Lifestyle Interventions for Treatment and Remission of Type 2 Diabetes and Prediabetes in Adults: A Clinical Practice Guideline From the American College of Lifestyle Medicine

Abstract

Objective: Diabetes is a defining disease of the 21st century because of its rising prevalence, association with obesity, and enormous health impact. Abundant evidence shows that lifestyle interventions can delay or prevent type 2 diabetes (T2D) in adults, offer relief, and sometimes achieve complete remission. Despite this empowering message, there are no clinical practice guidelines that focus primarily on lifestyle interventions as first-line management of prediabetes and T2D. Our objective, therefore, is to offer pragmatic, trustworthy, and evidence-based guidance for clinicians in using the 6 pillars of lifestyle medicine—nutrition, physical activity, stress management, sleep, social connectedness, avoidance of risky substances—for managing adults with T2D and in preventing T2D in adults with prediabetes or a history of gestational diabetes mellitus. Methods: We used well-established, peer-reviewed guideline methodology to develop evidence-based key action statements (recommendations) that facilitate quality improvement in clinical practice. The guideline development group included 20 members representing consumers, advanced practice nursing, cardiology, clinical pharmacology, behavioral medicine, endocrinology, family medicine, lifestyle medicine, nutrition and dietetics, health education, health and wellness coaching, sleep medicine, sports medicine, and obesity medicine. Recommendation strength was based on the aggregate evidence supporting a key action statement plus a comparison of associated benefits vs harms/costs. Multiple literature searches, conducted by an information specialist, identified 8 relevant guidelines, 118 relevant systematic reviews, and 112 randomized clinical trials. The guideline underwent extensive internal, external, and public review and comment prior to publication. Results: We developed 14 key action statements and associated evidence profiles, each with a distinct quality improvement goal in the context of lifestyle interventions for T2D. Strong recommendations were made regarding advocacy for lifestyle interventions; assessing baseline lifestyle habits; establishing priorities for lifestyle change; prescribing aerobic and muscle strength physical activity; reducing sedentary time; identifying sleep disorders; prescribing nutrition plans for prevention and treatment; promoting peer/familial support and social connections; counseling regarding tobacco, alcohol, and recreational drugs, and establishing a plan for continuity of care. Recommendations were made regarding identifying the need for psychological interventions and for adjusting (deprescribing) pharmacologic therapy. We include numerous tables and figures to facilitate implementation, a plain-language summary for consumers, and an executive summary for clinicians as separate publications. Conclusions: There is robust research evidence supporting the efficacy of lifestyle interventions in preventing, treating, and achieving remission of T2D in adults. Our multidisciplinary guideline development group successfully synthesized this evidence into 14 key action statements that can be used by clinicians and other healthcare professionals to improve quality of care for adults with, or at-risk for, T2D. Despite the research gaps and implementation challenges we highlight in the guideline we believe strongly that our recommendations have immediate relevance and can help raise awareness and shift the paradigm of T2D management towards optimal use of lifestyle interventions.

This guideline has been endorsed by the American Association of Clinical Endocrinology, American Academy of Physician Associates, American Association of Nurse Practitioners, American College of Clinical Pharmacology, Obesity Medicine Association, American Academy of Sleep Medicine, Association of Diabetes Care & Education Specialists, and National Board of Health and Wellness Coaches. It has been designated with an “Affirmation of Value” from the American Academy of Family Physicians and is supported by the Academy of Nutrition and Dietetics.

“There is robust and expanding evidence in this global epidemic as to how lifestyle changes can delay or prevent T2D, and in some cases achieve complete remission.”

Introduction

Diabetes has been termed an epidemic and a defining disease of the 21st century because of its rising prevalence, association with obesity, and enormous health impact.^1,2 In the United States (US) over 38 million people have diabetes (T2D) ³ (Table 1), making it the eighth leading cause of death. ⁴ Of the total number of individuals with diabetes, approximately 90-95% of these have type 2 diabetes. ⁵ The prevalence of diabetes and prediabetes in US adults are 14.7% and 38.0%, respectively, meaning that about one-half the US adult population has either condition. ³ Diabetes and prediabetes account for $413 billion and $43 billion of US annual healthcare spending, respectively, and people with diabetes account for 25% of total health care dollars.^6,7 Globally, about 1.3 billion people are expected to be living with diabetes by the year 2050, ⁸ with projected annual expenditures for T2D exceeding $1 trillion. ⁹

Table 1.

Definitions of Terms.

Term	Definition
Intervention	An action, strategy, or program that is intended to benefit an individual with a specific plan for implementation, monitoring adherence, and assessing outcomes.
Lifestyle interventions	One or more interventions, as defined above, based on the 6 pillars of comprehensive lifestyle change (Table 2).
Lifestyle medicine a	A medical specialty that uses therapeutic lifestyle interventions as a primary modality to treat chronic conditions including, but not limited to, cardiovascular diseases, T2D, and obesity. Lifestyle medicine certified clinicians are trained to apply evidence-based, whole-person, prescriptive lifestyle changes to treat and, when followed intensively, often reverse such conditions. Applying the 6 pillars of lifestyle medicine (Table 2) also provides effective prevention for these conditions.
Standard American diet (SAD)	Also called the Western diet, this eating pattern includes high sodium intake and excess calories from meats, added fats, processed foods, and refined carbohydrates, while lacking many nutrients found in fruits, vegetables, and whole grains. 10
Ultra-processed foods	Foods that are energy-dense and high in salt, additives, unhealthy fats, refined starches, and free sugars that are formulated to be attractive and to trigger the brain’s reward system and encourage excess eating. These foods can be poor sources of protein, dietary fiber, and micronutrients. 11
Whole-food, plant-predominant diet b	An eating plan composed primarily of nutrient-dense whole grains, vegetables, legumes, fruits, nuts, and seeds while avoiding or minimizing animal foods, refined foods, and ultra-processed foods.
Prediabetes	A condition characterized by blood glucose levels that are higher than normal but not high enough for a diabetes diagnosis. Prediabetes increases an individual’s risk of developing T2D and cardiovascular disease. There are no clear symptoms of prediabetes, so a person may have it and not know it unless they get blood tests for their sugar levels. A diagnosis of prediabetes is defined by the American Diabetes Association as average HbA1c of 5.7% to 6.4%.
Type 2 diabetes	Previously referred to as “non-insulin-dependent diabetes” or “adult-onset diabetes,” accounts for about 95% of all diabetes, and encompasses individuals who have relative (rather than absolute) insulin deficiency and have insulin resistance that is hepatic, peripheral, or both. At least initially, and often throughout their lifetime, these individuals may not need insulin treatment to survive. A diagnosis of T2D is defined by the American Diabetes Association as average HbA1c of ≥6.5% and is confirmed by a second test with a similar result. 12
Gestational diabetes mellitus	Occurs in the second half of pregnancy because placental hormones lead to insulin resistance; symptoms usually resolve after delivery, but although this condition (not symptoms) usually resolves after delivery it may sometimes persist. Even when it does resolve postpartum, these individuals have a much higher risk of developing T2D in the future.
Remission b	The disappearance of diabetes signs and symptoms for a specified minimum time without excluding the possibility of recurrence. Remission of T2D is defined by the American College of Lifestyle Medicine as HbA1c <6.5% for at least 3 months with no surgery, devices, or active pharmacologic therapy for the specific purpose of lowering blood glucose. 13
Medication deprescribing	Also called deintensification or de-escalation, refers to a planned and supervised process of withdrawal, discontinuation, dose reduction, or substitution of a medication that may be causing harm or is no longer providing benefit to the patient.

^aAmerican College of Lifestyle Medicine: about us, https://lifestylemedicine.org/about-us/.

^bBased on expert consensus. ¹³

Encouragingly, there is robust and expanding evidence in this global epidemic as to how lifestyle changes can delay or prevent T2D, and in some cases achieve complete remission (Table 1), such that glucose-lowering pharmacotherapy is reduced or eliminated. ¹³ Yet despite this empowering message, supported by robust and rapidly growing research, there are no clinical practice guidelines focusing primarily on lifestyle interventions (Table 2) as first-line management for T2D. Lifestyle interventions have long been demonstrated as being more effective than drug therapy (metformin) in preventing prediabetes from becoming T2D, ¹⁴ a finding reaffirmed in subsequent research.^15-18 Lifestyle interventions can also reduce the risk of gestational diabetes progressing to T2D. ¹⁹

Table 2.

Six Pillars of Lifestyle Medicine Interventions. ^a

Intervention	Description	Importance
Nutrition	Focuses on foods and food substances that provide energy and nutrients for health, including the behaviors and social factors that influence food choices.	Extensive scientific evidence supports a whole-food, predominantly plant-based eating plan as an important strategy in preventing chronic disease, treating chronic conditions, and, in intensive therapeutic doses, reversing chronic illness. Such an eating plan is rich in fiber, antioxidants, and nutrient-dense, with a variety of minimally processed vegetables, fruits, whole grains, legumes, nuts, and seeds.
Physical activity	Any movement of the body done through skeletal muscle contraction that causes the energy expenditure to be beyond its baseline.	Regular and consistent physical activity combats the negative effects of sedentary behavior. Engaging in general physical activity and purposeful exercise weekly builds mental health, overall health, and resiliency.
Stress management	The mechanisms involved in the body’s physiological arousal to survive a real or perceived threat.	Stress, when appropriate, may improve health and productivity, but in excess can lead to anxiety, depression, obesity, immune dysfunction and more. Helping people recognize negative stress responses, identify coping mechanisms and stress reduction techniques leads to improved well-being.
Sleep	Defined by how much sleep a person gets (sleep duration), when a person slept (sleep timing), and how well a person slept (sleep quality).	Inadequate or disordered sleep causes sluggishness, low attention span, decreased sociability, depressed mood, decreased daytime caloric burn, increased hunger, decreased satiety, insulin resistance, and decreased performance. 7 to 9 hours nightly is associated with optimal health; under 6 hours or more than 9 hours is associated with increased mortality.
Social connectedness	Exemplified by relationships wherein individuals feel seen, heard, and valued, and from which they derive sustenance and strength.	Positive social connections and relationships affect our physical, mental, and emotional health. Leveraging the power of relationships and social networks can help reinforce healthy behaviors.
Avoidance of risky substances	Avoiding tobacco, recreational drugs, and excessive alcohol consumption.	Tobacco and excessive alcohol consumption increase the risk of chronic diseases and death, with similar impact from opioids and recreational drug use. Treatments take time, requiring varying approaches and many attempts, with patience and support essential to cease risky substance habits.

^aAdapted from the American College of Lifestyle Medicine's 6 pillars of lifestyle medicine. ²⁰

Lifestyle interventions for adults with T2D can improve quality of life, promote weight loss, optimize glucose management, reduce cardiovascular risk factors, facilitate medication deprescribing (Table 1), increase employment, and achieve full remission.^21-24 These effects are causal, not associational, ²⁵ apply to low- and middle-income countries, ²⁶ and have been achieved in individuals who leave their usual place of residence for reasons other than conflict or persecution. ²⁷ Unfortunately, these benefits are not being fully realized because only about 20% of US adults surveyed in 2020 reported a healthy lifestyle that included at least 4 of the following: healthy diet (25% prevalence), healthy weight (25%), never smoking (58%), sufficient physical activity (69%), and moderate or lighter alcohol consumption (91%). ²⁸

Despite decades of research on the efficacy of lifestyle interventions for T2D, drug therapy remains the current mainstay of management, consistent with the growing preference among US adults for medication over lifestyle change, rising from 16% in 2012 to 38% in 2022, with nearly 50% of those under 50 years opting for medication. ²⁹ Medications for managing diabetes include insulin and non-insulin medications such as metformin, sulfonylureas, DPP-4 inhibitors, sodium-glucose cotransporter inhibitors (SGLT-2i) or, increasingly, glucagon-like peptide-1 (GLP-1) receptor agonists. ³⁰ Drug therapy for diabetes offers significant benefits, but can cause adverse events, such as hypoglycemia from insulin use that may be severe enough to require glucose or glucagon intervention, or potentially lead to coma or death. ³¹ Metformin, while promoting glucose management and being weight-neutral, has known adverse effects that include gastrointestinal disorders, reversible vitamin B12 deficiency, and less commonly, lactic acidosis. SGLT-2i drugs may cause genital yeast infection, urinary tract infection, and rarely, diabetic ketoacidosis or acute kidney injury (from hypovolemia).^30,31 The most common adverse event with GLP-1 receptor agonists is gastrointestinal disorders, usually mild to moderate, but sometimes severe enough to require discontinuation. Moreover, as the popularity of GLP-1 receptor agonists soars for chronic weight management, potentially serious adverse effects are increasingly reported that include pancreatitis, bowel obstruction, gastroparesis, acute gallbladder disease, pulmonary aspiration (during general anesthesia), reduced lean muscle mass, nonarteritic anterior ischemic optic neuropathy, and possible self-injury or suicidal thoughts.^30-34

The rise in diabetes prevalence, plus growing evidence on the efficacy of lifestyle interventions and the potential harm of pharmacological therapy, suggest a need for a paradigm shift, with lifestyle interventions as the consistent foundation of first-line management, ³⁵ based on actionable recommendations and pragmatic implementation strategies. Existing guidelines for prediabetes and T2D do have nutritional recommendations, but they can be extensive and complex, dealing with energy balance, glycemic load, macronutrient composition, and medical nutrition therapy. ³⁶ A healthy pattern of eating is advised in broad terms or with specific approaches including Mediterranean, Nordic, DASH (dietary approaches to stop hypertension), and vegetarian.^37,38 These approaches tend to emphasize practice over principles, rarely discuss a whole-food, plant-predominant eating plan (Table 1), do not always condemn ultra-processed foods, and have been questioned as not necessarily being culturally sensitive or appropriate. Current (2025) Standards of Care in Diabetes from the American Diabetes Association, however, place greater emphasis on eating healthy whole plant foods and plant sources of protein, while minimizing consumption of red meat, sweets, sugar-sweetened beverages, refined grains, and processed or ultra-processed foods. ³⁹

Lifestyle interventions are the cornerstone of therapy for lifestyle medicine, a specialty that prevents, treats, and in some cases can reverse chronic disease—including T2D—using the 6 pillars of active intervention (Table 2), plus strategies to implement and support behavior change. ⁴⁰ As an essential component of primary care, and a foundational component of all health professional education, lifestyle medicine services can be delivered through in-person or virtual appointments, either individually or in a group visit setting. There is strong, multidisciplinary consensus that lifestyle modifications are the first line of treatment in the standard of care for obesity, prediabetes, T2D, cardiovascular diseases, and other conditions impacted by lifestyle that involve chronic inflammation. ⁴⁰ Notably, the American Diabetes Association Standards of Care in Diabetes increasingly emphasizes lifestyle behavior change for preventing and managing T2D, including healthy eating, physical activity, and, sleep health. ⁴¹

The intent of this guideline is to offer clear, pragmatic, and actionable recommendations for clinicians and healthcare professionals seeking to implement lifestyle interventions for individuals with prediabetes, T2D, or a history of gestational diabetes mellitus (GDM). We do not seek to replace existing guidelines or standards, but rather to enhance awareness of lifestyle interventions in preventing and managing T2D, while also adding nuance and practical strategies for expanding upon any existing lifestyle recommendations. Additionally, we offer an in-depth summary of the current best evidence regarding lifestyle interventions for T2D, including coaching strategies and behavior change, supported by extensive tables, figures, and handouts to facilitate implementation.

Purpose

The rationale for this clinical practice guideline (CPG) is a high, and rising, prevalence of prediabetes and T2D in adults, often accompanied by obesity or other chronic conditions that shorten life and worsen health. At the same time, there has been substantive growth in lifestyle medicine as a medical specialty ⁴² and the supporting research evidence as to how different lifestyle interventions can benefit adults with T2D and many other chronic, non-infectious diseases. Despite this growth in knowledge and experience, our guideline development group (GDG) perceived an underappreciation and underutilization by clinicians, individuals, and the public regarding the scope, impact, and utility of lifestyle interventions in managing adults with T2D.

As the first multidisciplinary CPG emphasizing lifestyle interventions as primary therapy for prediabetes, T2D, and GDM, we seek to empower clinicians and individuals in preventing progression of prediabetes and GDM, and in achieving remission or improved glycemic management without medication intensification for T2D. We provide clear, actionable, and evidence-based recommendations, using a trustworthy guideline process, to synthesize current best evidence into pragmatic opportunities for quality improvement. ⁴³ This CPG is the natural extension of prior efforts by the American College of Lifestyle Medicine (ACLM), beginning with a position statement on T2D remission, ⁴⁴ followed by an expert consensus statement on dietary interventions to achieve remission in many adults. ¹³

The CPG scope was delineated in PICOT format as follows:

• • Population: non-pregnant adults, aged 18 years and older, with T2D, prediabetes, or a history of GDM.

• • Intervention: one or more lifestyle interventions (Table 2), administered as primary or adjuvant therapy, with specified duration and intensity.

• • Control or comparator: any concurrent group in a study managed the same as the lifestyle intervention group except for the lifestyle intervention (e.g., lifestyle intervention vs usual/standard care, or medication ± lifestyle intervention).

• • Outcomes: objective measures (labs, health metrics), quality of life (general & disease-specific), optimizing medical treatment (including deprescribing), symptomatic improvement (e.g., neuropathic pain), incidence of complications (avoiding, preventing, mitigating), impact on other outcomes (wound healing), impact on health equity/disparities, cost-effectiveness/efficiency, mortality (increased lifespan), burden of care on individual and caregiver, work productivity, clinician and healthcare professional satisfaction.

• • Time frame: intermediate and long-term, guided by the available research evidence.

Our target audience for the CPG is any clinician or healthcare professional in a community or non-inpatient healthcare setting involved in managing non-pregnant adults with T2D, prediabetes, or a history of GDM. Excluded from the CPG are research on diagnosis of diabetes, research on screening for diabetes, individuals with active GDM, inpatient hospital settings, assisted living settings, diabetes from pancreatic insufficiency, cystic fibrosis related diabetes, and post-transplantation diabetes.

In planning the guideline content, we began by brainstorming to identify all potential topics that might lead to guideline recommendation statements. This expansive list (Table 3) assisted the GDG with capacious thinking about how to proceed, recognizing that only a small portion of the topics would rise to a recommendation level. We excluded consideration of pharmacologic therapy or endocrine (metabolic) surgery because these topics are already fully covered in other diabetes guidelines from diverse national organizations and medical specialty societies. For a list of commonly used abbreviations and definitions used throughout the guideline, please refer to Table 4.

Table 3.

Brainstorming List of Potential Topics to Consider in Guideline Recommendation Statements.

Subject	Potential Topics
Nutrition	Whole-food, plant-predominant eating plan, keto eating plan, intermittent fasting, carbohydrate counting, Mediterranean eating pattern, time-restricted eating plan, low-fat eating plan, caloric restriction, time restriction, meal replacement, liquid eating plans, mindful eating, DASH eating plan, ADA individualized eating plan, flexitarian eating plan, high-fiber eating plan, fiber intake, saturated fat intake, polyunsaturated fatty acid intake, monounsaturated fatty acid intake, ultra-processed food intake, sugar-sweetened beverage intake, water intake.
Physical activity	Strength, aerobic, flexibility, balance, non-exercise activity thermogenesis, high-intensity interval training, interval, physical therapy, soleus pushups, walking, yoga, exercise snacks, exercise for individuals with disabilities, standing intervention, decreased sedentary time, daily step count, accelerometer, fitness tracker, walking groups, exercise prescription.
Stress management	Breathing exercises, mindfulness-based stress reduction, meditation, cognitive behavior therapy, yoga, pharmacologic therapy, counseling, music therapy, psychotherapy, physical activity, qigong, tai chi, marijuana, nature therapy/forest bathing, journaling, gratitude practice, bibliotherapy, volunteering, spirituality/faith, music, crafts.
Avoidance of risky substances	Tobacco, alcohol, illicit drugs, recreational drugs, abuse of prescription drugs, air, and environmental pollutants.
Restorative sleep	Insomnia, sleep apnea, restless leg syndrome, shift-work disorder, CPAP, sleep hygiene, sleep deprivation, circadian rhythm disorder, social jet lag, melatonin.
Social connectedness	Group visits, couples therapy, cultivating high-quality connections, walking groups, group exercise classes, community groups, volunteering with groups, faith-based organizations, workplaces.
Behavior change	Cognitive behavior therapy, readiness to change, health/wellness coaching, motivational interviewing, group visits, behavioral medicine, transtheoretical model, general coaching, peer/family support, self-management, digital coaching/apps, social media.
Person engagement	Counseling, education, FAQ lists, coaching, apps, risks of prediabetes, complications of diabetes, future risk of prior GDM, role of lifestyle interventions in management, opportunities for remission, shared decision-making, person-centered care, texting.
Health disparities and inequities	Access to care, food deserts vs swamps, food apartheid, social determinants, cultural barriers, venues & supplies (equipment, clothing, facilities) for physical activity, language barriers, disabilities, social norms, default choice architecture, lack of insurance coverage, unemployment, lack of public transportation (access to care, appointments), racism.

ADA, American Diabetes Association; FAQ, frequently asked questions; GDM, gestational diabetes mellitus.

Table 4.

Abbreviations and Definitions Used in the Guideline.

Abbreviations and Definitions of Common Terms
Term	Definition
ACLM	American College of Lifestyle Medicine
ADA	American Diabetes Association
BMI	Body Mass Index
CBT	Cognitive Behavioral Therapy
CBT-I	Cognitive Behavioral Therapy for Insomnia
CHW	Community Health Worker
CPAP	Continuous Positive Airway Pressure
CPG	Clinical Practice Guideline
DASH	Dietary Approaches to Stopping Hypertension
DPP	Diabetes Prevention Program
EVS	Exercise Vital Sign
FITT	Frequency, Intensity, Time, Type
GDG	Guideline Development Group
GDM	Gestational Diabetes Mellitus
HbA1c	Hemoglobin A1c
HCP	Healthcare Professional
HWC	Health and Wellness Coaching
IVGTT	Intravenous Glucose Tolerance Testing
KAS	Key Action Statement
OARS	Open-ended questions, Affirmations, Reflections, Summaries
OSA	Obstructive Sleep Apnea
PAP	Positive Airway Pressure
PAVS	Physical Activity Vital Sign
PWD	Person With Diabetes
RCT	Randomized Controlled Trial
RDN	Registered Dietitian Nutritionist
SMART	Specific, Measurable, Achievable, Relevant, and Time-Bound
T2D	Type 2 Diabetes

Healthcare Burden

Diabetes has been part of the human experience since antiquity. Ancient Indian, Chinese, Arab and Greek physicians commented on individuals with characteristically sweet and sticky urine, along with polydipsia and polyuria, often employing ants that were attracted to the urine as part of their diagnostic armamentarium. ⁴⁵ Several early physicians also noted the preponderance of diabetes among the wealthy, especially those consuming excessive amounts of calorie-rich foods. ⁴⁵ Yet, despite thousands of years of study, diagnosis, and treatment, diabetes remains stubbornly present—and on the rise—in our society. A new approach, emphasizing healthy lifestyle choices, is imperative to address the root causes of insulin resistance and impaired glucose metabolism, instead of emphasizing lifelong pharmacologic therapy for glucose management and symptomatic relief.

The prevalence of diabetes is accelerating at an alarming rate, considering that in 1958 under 1% of the US population was affected. ⁴⁶ In just over 60 years, the prevalence of diabetes (type 1 and type 2) in the adult population in 2020 reached 13.2%, ⁴⁶ with an additional 36.5% meeting the criteria for prediabetes. ⁴⁶ Globally, the prevalence of diabetes rose 5-fold within 4 decades, from 108 million people in 1980 to 529 million in 2021. ⁹ By 2050, the estimated global prevalence will more than double, exceeding 1.31 billion individuals. ⁸

The healthcare burden, prompted by a rising prevalence of diabetes, is compounded by a concurrent increase in diabetes complications, both traditional and emerging. ⁴⁷ Traditional complications include stroke, coronary heart disease, peripheral neuropathy, retinopathy, kidney disease, and peripheral vascular disease. Emerging complications, which are a consequence of increased life expectancy from advances in management, include cancer (especially gastrointestinal and female-specific), foot and kidney infections, nonalcoholic fatty liver disease, functional disability, cognitive disability, and affective disorders. ⁴⁷ These complications, however, are beyond the scope of this guideline and will not be discussed further.

Health Disparities

Community factors can have a large impact on diabetes outcomes. Housing insecurity impacts about 38% of US adults with diabetes and is associated with lower rates of seeing a physician, checking HbA1c, getting an eye examination, and receiving a flu vaccine. ⁴⁸ Limited access to food because of financial constraints (food insecurity) is associated with higher HbA1c for adults with T2D. ⁴⁹ Living conditions can also affect T2D complications, as indicated by disproportionately higher rates of lower extremity amputations among adults in the US who live in underserved communities. ⁵⁰

The burden of living with diabetes varies by race and ethnicity. The adult prevalence of diagnosed diabetes, between 2019 and 2021, was 13.6% in American Indians and Alaskan Natives, 12.1% in non-Hispanic Blacks, 11.7% in Hispanics, 9.1% in Asians, and 6.9% in non-Hispanic Whites. ³ An even higher age- and sex-adjusted adult prevalence was found in the National Health and Nutrition Examination Surveys, between 2011 and 2016, reaching 22.1% for Hispanics, 20.4% for non-Hispanic Blacks, 19.1% for non-Hispanic Asians, and 12.1% for non-Hispanic Whites. ⁵¹ In Hawaii, where most of the population consists of Asians, Native Hawaiians and Other Pacific Islanders (NHOPIs), the highest adjusted prevalence of diabetes occurs in NHOPIs and Filipinos, with lower prevalence in Japanese adults, and the lowest in White adults. ⁵²

Within these categories, there is marked clinical and genetic diversity. For example, among Hispanic adults, the highest prevalence of total diabetes was in Mexicans at 24.6%, followed by 21.7% for Puerto Rican, 20.5% for Cuban/Dominican, 19.3% for Central American, and 12.3% for South American subgroups (overall P < .001). ⁵¹ Puerto Rican-identified adults living in the continental US are disproportionately impacted by disparity, as demonstrated by poor diabetes outcomes and suboptimal diabetes self-care. ⁵³ Among non-Hispanic Asian adults, the prevalence of total diabetes was lower among East Asian individuals at 14.0% compared with 23.3% for South Asian individuals, and 22.4% for Southeast Asian subgroups. ⁵¹ American Indians and Alaska Native adults are over 3 times more likely to have diabetes than non-Hispanic White adults, over twice as likely to have diabetes as an underlying cause of death, and twice as likely to be diagnosed with end-stage renal disease. ⁵⁴

There are significant racial and ethnic disparities in diagnosing diabetes—because of infrastructure, resources, and access in minoritized communities—with a prevalence of undiagnosed diabetes in adults of 2.7% in non-Hispanic White people, 4.7% in non-Hispanic Black people, 4.4% in Hispanic people, and 5.4% in non-Hispanic Asian people. ³ Overall undiagnosed diabetes is seen in 3.4% of all US adults and 22.8% of all US adults with diabetes. ³ Undiagnosed cases of diabetes are defined as meeting the laboratory criteria for diabetes and the person is unaware of, or has not reported, having diabetes. ³ The prevalence of undiagnosed diabetes in US adults is also subject to disparities based on immigration status, with rates about twice as high for noncitizens and 50% higher for naturalized citizens when compared to native-born citizens, even after accounting for health insurance. ⁵⁵

Disparities in diabetes, based on immigration status, may be partly explained by language barriers. For example, limited English proficiency is associated with significant health disparities for North American adults with T2D, including poor glucose management, a higher incidence of T2D-related complications, and suboptimal patient-provider interactions. ⁵⁶ Further, when adults with T2D require interpreters to communicate, they are more likely than proficient English speakers to have HbA1c levels of at least 7% and elevated HbA1c levels accompanied by hypertension. ⁵⁷

Disparities can also be found when considering GDM. Compared to a 21% incidence of T2D in non-Hispanic White individuals with a history of GDM, the risk of incident T2D was 32% for Hispanic individuals and for non-Hispanic Black individuals. ⁵⁸ Greater disparities were seen in a New York City cohort, ⁵⁹ where White individuals with a history of GDM had a 5.4% risk of T2D over 8 years, compared to 18.5% in Black individuals, 16.8% in South and South Asian individuals, and 14.6% in Hispanic individuals. In addition, for individuals with a history of GDM, rates of postpartum follow-up exhibit disparities linked to Black race, Hispanic ethnicity, low level of education, and coexisting morbidities such as mental health disorders. ⁶⁰

Age and Body Mass Index (BMI) Factors

Nearly 90% of adults with T2D in the US have overweight (27%), obesity (47%), or extreme obesity (16%), reflecting the strong link between diabetes and BMI. ³ Globally, rising obesity rates significantly contribute to the increasing prevalence of T2D, with obesity responsible for about 30%-50% of new cases annually in the US and worldwide. ⁶¹ Although T2D is much less common among lean adults (BMI of <25 kg/m²), the prevalence in this group is also rising, with the largest growth in Black, Hispanic, and female populations. ⁶²

South and Southeast Asian people tend to be diagnosed with diabetes at lower BMIs, a trend persisting even in their early adult years. ⁶³ In the US and Canada, South Asian people in the normal weight bracket consistently exhibited higher diabetes prevalence than their White peers. ⁶⁴ Similarly, from the United Kingdom Clinical Practice Research Datalink, ⁶⁵ among individuals diagnosed with T2D between 1998 and 2015, South Asian people and Black people developed diabetes a decade earlier compared to other groups. The HbA1c levels were also higher in those with younger onset diabetes, particularly in Black people. ⁶⁵ In the California Health Interview Survey ⁶⁶ adjusted regression model, ages at diagnosis were 10.5, 8.7, 8.4, and 4.2 years earlier among South Asian, Vietnamese, Filipino, and Korean populations, respectively, as compared to non-Hispanic White people; no significant difference in age at diagnosis was noted for Chinese and Japanese populations.

Social Determinants of T2D and Prediabetes

Assessing the social determinants of T2D and prediabetes is important for identifying root causes and in addressing health disparities, but the interrelated nature of many of these determinants raises the potential for confounding. Therefore, the factors we describe next should not necessarily be viewed as independent predictors, but as part of the complex network of social determinants of disease risk, status, and outcomes.

Higher educational attainment is inversely correlated with developing diabetes, with only 6.9% of adults who have more than a high school education being diagnosed compared with 13.1% who did not finish high school. ⁴⁶ Only 5.1% of adults who report family incomes at least 5 times the federal poverty level developed diabetes, compared to 13.1% who reported being below poverty level. ⁴⁶ Living in a food-insecure household increases the risk of developing diabetes about 50% higher than adults living in food secure households. ⁶⁷ Adults diagnosed with diabetes who live in food-insecure households are also more likely to experience uncontrolled disease with a HbA1C above 8%. ⁶⁷

Unemployment is associated with increased odds of 58% for prediabetes and 72% for T2D. ⁶⁸ Further, shift work is associated with higher risk of diabetes than working normal daytime schedules in a meta-analysis of observational studies. ⁶⁹ A U.S. population-based survey found highest prevalence of diabetes among transportation workers and lowest prevalence among physicians. ⁷⁰ Among other social determinants of health (SDOH), a qualitative study found that unstable housing made self-care, self-management routines, affording diabetes medications and supplies, and eating healthy foods more challenging. ⁷¹

Housing interventions may facilitate access to diabetes care. People with diabetes who were provided with housing support were about 10% more likely to receive HbA1c tests and lipid tests, while for people without baseline diabetes, housing support was associated with a 13% lower risk of new diabetes diagnoses. ⁷² Moreover, there were 54% higher present-day diabetes mortality rates attributable to structural racism, as captured by historic residential redlining practices from a dataset from Seattle, Washington. ⁷³ Environment is also important, with high exposure to neighborhood greenspace (defined as open, undeveloped land with natural vegetation and/or spaces such as parks and tree-lined areas) associated with a 29% lower incidence of T2D. ⁷⁴ Conversely, diabetes risk is higher in populations exposed to environmental chemicals including arsenic, persistent organic pollutants, phthalates, and possibly bisphenol, as well as those exposed to air pollution with higher concentrations of particulate matter of <2.5 μm aerodynamic diameter. ⁷²

Comorbidities

Nearly 30% of people with T2D have 3 or more comorbid conditions at diagnosis, increasing to 60% of people with T2D for 10 years or longer. ⁷⁵ Hypertension and obesity are some of the most common comorbid conditions, but others include cardiovascular disease, retinopathy, renal disease, depression, back pain, osteoarthritis, and asthma. ⁷⁵ Although less common that the preceding comorbid conditions, adults with T2D are also at higher risk for Alzheimer’s disease. ⁷⁶ The COVID-19 pandemic revealed another insidious risk for people with diabetes: a death rate about twice as high after infection with SARS-CoV-2 compared to controls without diabetes. ⁷⁷ Quality of life is also adversely affected by diabetes, especially in the presence of micro- or macro-vascular complications. ⁷⁸

Prediabetes and GDM

An estimated 97.6 million US adults (36.5% of all adults) aged 18 years or older had prediabetes in 2021, ⁴⁶ based on their fasting glucose or HbA1c level, more often in men than women (41% vs 32%). However, only 19% of adults with prediabetes reported being told by a health professional that they had this condition. ⁴⁶ Although the prevalence of prediabetes in this study was similar among all racial and ethnic groups and education levels, the rate of progression to T2D was more rapid among certain ethnicities (e.g., South Asian people). ⁴⁶

In the US, the Centers for Disease Control and Prevention ⁴⁶ reported that 2% to 10% of all pregnant women are diagnosed with GDM annually. ⁷⁹ From 2016 to 2020, the rate of GDM increased by 30%, with 7.8 cases per 100 births in 2020 compared to 6.0 cases per 100 births in 2016. Further, non-Hispanic Asian mothers experience the highest rate of GDM, with approximately 14.9 cases per 100 births. ⁸⁰

Although non-Hispanic Black individuals have a lower risk of developing GDM (6.5 per 100 births) compared to the general population, they are approximately 10 times more likely to develop subsequent T2D after a GDM diagnosis. ⁵⁸ The 2020 GDM rate for mothers under age 20 was approximately 2.5%, substantially lower than the 15.3% rate observed among those aged 40 and above. ⁷⁹ Additionally, individuals residing in low-income communities are disproportionately affected by GDM. ⁸¹

Financial Impact of Diabetes

The financial cost of the diabetes epidemic includes direct medical costs in the US in 2022 estimated at $306.6 billion and additional indirect costs of $106.3 billion. ⁷ People with diabetes spend approximately 2.6 times more on yearly healthcare costs compared to those without the diagnosis. ⁷ The total projected healthcare expenditure costs for 2022 were approximately $2.0 trillion, of which $503.4 billion was incurred by people with diabetes, representing 25% of all health care dollars, with 15% of spending attributable directly to diabetes. ⁷

Direct Cost of Diabetes and Prediabetes

The direct costs of diabetes (type 1 and type 2) increased in the US by $80 billion dollars from 2012 to 2022. ⁷ In the US, excess costs associated with medications constitute almost half (44%) of the total direct medical burden of diabetes, including 7% for insulin, 9% for non-insulin glucose-lowering agents, and 28% for other prescription medications. ⁷ Healthcare resource use is another important cost, with almost 1 out every 5 healthcare dollars spent on inpatient hospitalization directly attributable to diabetes. Similarly, office visits to clinicians and other HCP (e.g., podiatrists, home health care) are much higher among people with diabetes ($33.6 billion) compared to the population without diabetes. The direct medical costs—across all categories including prescriptions or diabetes supplies, hospitalization, or office visit costs—are much higher among seniors aged 65 or older compared with younger individuals. A substantial majority (61%) of diabetes costs are for adults aged 65 or older, which is mainly paid by Medicare. ⁸²

Additionally, the comorbid conditions that often accompany diabetes are expensive, including chronic kidney disease and treatment for ketoacidosis, which can increase the cost for people with diabetes to an average of over $68,000 per year. ⁸³ Although ketoacidosis is less common in people with T2D compared to those with type 1 diabetes, the incidence with T2D is nontrivial and remains stable at 1.7 to 1.8 per 1000 patient-years. ⁸⁴ An analysis of commercial claims data found that in the first 5 years after diagnosis, those with diabetes spent $8941 more than control subjects without diabetes, with $4828 in the year of diagnosis (possibly indicating a higher prevalence of prediabetes than suspected). ⁸⁵ The total annual costs, direct plus indirect, for prediabetes and GDM have been estimated as $43.4 billion and $1.6 billion respectively, with annual per-case burdens of $5800 and $500. ⁶ Employees with diabetes cost employers billions of dollars annually, with expenditures growing approximately 20% year over year, which is twice as fast as the costs for employees without a diabetes diagnosis. ⁸³

A systematic review assessing the global economic burden of T2D found that direct diabetes costs were closely and positively associated with a country’s gross domestic product (GDP) per capita, and that the US stood out as having particularly high costs, even after controlling for GDP. ⁸⁶ Another systematic review of cost-of-illness of adults with T2D in low and lower-middle income countries (LMIC), found that direct costs ranged from $107 US to $294 US per person per year. ⁸⁷ In contrast to the US, where prescription medication costs are the primary cost drivers, hospitalization cost was the major contributor of direct costs followed by drug costs in the LMICs. ⁸⁷

Indirect Costs of T2D and Prediabetes

The major contributors to indirect costs based on US data from 2022 were $28.3 billion from disability-related reduced employment, $35.8 billion from reduced workplace productivity, and $32.4 billion from premature employee deaths. ⁷ Further, the average per capita indirect annual cost among US adults was $4357 among non-Hispanic Whites, compared to $4749 among non-Hispanic Black adults. Breaking down these indirect costs systematically, the average cost per premature death averaged approximately $95,658 per-case across all ages; however, the cost from premature death in someone who dies from diabetes-related causes at the younger ages of 45 to 54 years of age is approximately $700,000 per case. This finding was corroborated by another cost analysis that found indirect costs are much higher than direct medical costs when T2D is diagnosed at a younger age. ⁸⁸

In terms of indirect costs of decreased employment, if people with diabetes participated in the labor force at rates similar to their peers without diabetes, there would be an estimated 447,000 to 2,000,000 additional people between the ages of 18 and 64 years in the workforce, a staggering number that is almost entirely attributable to T2D. Other indirect costs included $4.4 billion for reduced productivity days if unemployed, and $5.4 billion for absenteeism or missed workdays if employed. Another study ⁸⁸ based on secondary analysis of the Look AHEAD trial, compared labor outcomes 7 years before and 15 years after randomization, finding 2.9% increased employment in the lifestyle intervention group compared to controls, with no relative change in disability benefit receipt. The impact was higher for individuals with less than a college degree, with a 7% increase in employment plus reductions in disability benefit receipt and payments, notably from improvement in mobility loss (48% reduction in the first 4 years of the trial).

Direct Cost of Obesity

A 15-year analysis of Medical Expenditure Panel Surveys of adults aged 20 to 65 years in the US found that adults with obesity experienced higher annual medical care costs by $2,505, or 100% more than with those with normal weight. ⁸⁹ Costs increased significantly with class of obesity, from 68.4% for class 1 to 233.6% for class 3, with higher costs in every category of care: inpatient, outpatient, and prescription drugs. ⁸⁹ Adding one unit of BMI increased annual expenditures paid by public insurance by $240, and that paid by private insurance by $163. The total direct medical costs of adults with obesity more than doubled from $124.2 in 2001 to $260.6 billion in 2016. In 2016, $139.4 billion was paid by private health insurance, $57.9 billion was paid by public health insurance programs, and $20.0 billion was paid out of pocket by individuals for obesity-related care. ⁸⁹

Economic Benefits of Therapeutic Lifestyle Interventions

Lifestyle interventions have the potential to reduce the direct and indirect costs of diabetes, through medication deprescribing, reduced needs for medical care, fewer complications, less comorbid conditions, and better work productivity and engagement when maintaining a wholesome, balanced eating plan, restful sleep, adequate physical activity, stress reduction, not smoking, and positive social connections.^90-95 Acquiring these habits, however, can incur expenses related to coaching, shared medical appointments, or intensive therapeutic lifestyle T2D remission or prevention programs, but as noted in the examples that follow there can be an overall cost savings.

Secondary analysis of data from the UK Diabetes Remission Clinical Trial (DiRECT) found that lifestyle intervention could achieve a mean total lifetime cost savings per participant of £1337 ($1716), beginning within 6 years. ⁹⁶ Another study of intensive lifestyle interventions for adults with T2D achieved remission rates of 78% at 1 year and 51% at 5 years, with a mean cost savings of per case of $765 over 5 years. ⁹¹ US data on cost savings for T2D remission in the immediate 3-year period following the lifestyle intervention in the Look AHEAD (Action for Health in Diabetes) for diabetes remission found lower prescription drug costs by $803 but no difference in total Medicare spending when compared to age and sex matched controls. ⁹³ The lifestyle intervention, however, was more expensive (compared with other international studies) costing $2865 per patient per year in the first year and gradually decreasing to $1120 per patient per year in years 5 to 9 (in 2012 dollars). ⁹³ More recent analysis found significant indirect cost savings from the Look AHEAD trial, including higher employment rates that disproportionately improved for individuals with lower educational attainment rates (see below).

Preventing progression of prediabetes to T2D is also estimated to afford major cost savings in multiple studies. ⁴⁶ One analysis ⁹⁵ used a potential budget impact model and estimated 5-year cost savings of $1146 per participant for in-person classes and $618 for online. A 3-year cost-effectiveness analysis from the Diabetes Prevention Program (DPP) found lifestyle intervention to be more cost-effective than the metformin intervention in preventing prediabetes progression, from the perspective of both a health system and society. ⁹² The authors estimated that DPP lifestyle intervention would cost $3100 to $7900 per quality-adjusted life year (QALY) compared with the placebo intervention over a lifetime, even if future adherence and effectiveness of the lifestyle intervention were 20% to 50% less than that observed in DPP. They noted that published cost per quality adjusted life years (QALY) relating to prevention and treatment ranged from less than $10,000 to over $1 million, with most between $10,000 and $50,000.

In the Medicare population, mammography, anti-hypertensive treatment, and cholesterol treatment for secondary prevention of cardiovascular disease have been estimated to cost between $10,000 and $60,000 per QALY, thereby highlighting the cost savings from DPP style lifestyle interventions. This study looked at excess costs associated with being at risk for T2D diagnosis, stratified into low, medium, and high risk and found an average of $1028, $4828, and $11,876 cost savings annually for the 3 risk categories (high risk: diagnosis imminent <1-year, medium risk: diagnosis ∼1 year away, low risk: diagnosis >1 year away). ⁹⁰

The cost savings from lifestyle interventions for GDM were studied using a decision-analytic Markov model to compare the health and cost-effectiveness outcomes for a structured lifestyle intervention in Australia during pregnancy to prevent GDM and subsequent T2D from current usual antenatal care. ⁹⁴ Costs incorporated both healthcare and societal perspectives, using an intervention effect based on published meta-analyses. The intervention was cost saving compared with usual care from a healthcare perspective, and returned Australian $1.22 per dollar invested, due to a reduction in adverse health outcomes for individuals during both the perinatal period and over their lifetime.

Methods

This CPG was developed based on established methodology that has been published, peer-reviewed, and used successfully in developing many multidisciplinary guidelines. ⁴³ This a priori methodology is aimed at creating pragmatic, evidence-based key action statements (KAS) that facilitate quality improvement in clinical practice.

Stakeholder Involvement

The American College of Lifestyle Medicine (ACLM) assembled a Guideline Development Group (GDG) of 20 members, including 12 physicians (MD or BCh), a clinical health psychologist (PhD), lifestyle medicine researcher (PhD), nurse practitioner, physician associate, registered dietitian nutritionist, a certified diabetes care and education specialist who is also a dietitian, and 2 consumer advocates. These panel members represented the disciplines of advanced practice nursing, cardiology, clinical pharmacology, behavioral medicine, endocrinology, family medicine, lifestyle medicine, nutrition and dietetics, health education, health and wellness coaching, sleep medicine, sports medicine, and obesity medicine. The GDG participated in 3 conference calls and 2 in-person, 2-day, meetings to define the scope and objectives of the guideline, including identifying quality improvement opportunities, systematically reviewing, and assessing published literature identified via literature searches, developing statement evidence profiles, and drafting the KAS recommendations.

Literature Search and Selection of Evidence

ACLM staff conducted 3 literature searches working with an information specialist. Search strategies were based on the PICOTs criteria noted above, and the full search strategy is included in the online Appendix. Search terms included T2D, prediabetes, and GDM.

The first search, conducted in September 2023 in PubMed, Embase, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL), aimed to identify other practice guidelines, systematic reviews, and meta-analyses on the topic of lifestyle, health behaviors, and T2D. After de-duplicating, this search yielded a total of 5377 abstracts that were first screened by 2 GDG members (MK, KLS) who identified 294 abstracts as potentially relevant, based on studies conducted among humans and having an outcome related to blood glucose, medication use, or diabetes remission. The GDG chair and co-assistant chairs (RR, MG, MG) then conducted a final screening of the 294 abstracts, identifying 184 as relevant and meeting quality standards for inclusion. ⁴³ The final list included 8 CPGs and 176 systematic reviews.

The second search, conducted in November and December 2023 in PubMed, Cochrane Central Register of Controlled Trials, Embase, and CINAHL, aimed to identify randomized controlled trials (RCTs) on the topic of lifestyle interventions and T2D. This search generated 4451 potentially eligible abstracts that were initially screened by 2 authors (MK, KLS) who identified 732 as potentially relevant. The GDG chair and co-assistant chairs again conducted a screen of the 732, identifying 550 as relevant and grouping them thematically. Finally, after in-person meeting 1, it was identified that a supplemental search on de-escalation of T2D medications was needed. This search was conducted in PubMed and Medline, yielding 233 potentially relevant abstracts. Given that the amount of published literature on this topic was known to be limited, the search was not restricted to specific study designs, and only one round of abstract screening (MK, KLS) was conducted. Fifty-seven abstracts were identified.

All search strategies were restricted to publications in English, were adjusted to the appropriate syntax for each database, and the search lines are detailed in a supplemental file. An academic librarian with expertise in information services worked closely with 2 authors (MK, KLS) to build and execute the searches. In certain instances, targeted searches were performed by GDG members to address gaps from the systematic searches identified in writing the guideline from January 2024 through August 2024.

Abstracts were initially included if they met the criteria of focusing on people with T2D and lifestyle change or T2D and health behaviors with a focus on glucose, HbA1c, or insulin resistance as one of the outcomes of interest. The search for lifestyle was intentionally broad (see online Appendix) and included specific searches on lifestyle, health behavior, and the 6 individual pillars of lifestyle medicine (eating plan, physical activity, sleep, stress management, positive social connection, and avoidance of risky substances). Following screening by the leadership, individual section authors reviewed literature identified as thematically pertinent to their topic and best suited to support the guideline.

No new systematic reviews or meta-analyses were conducted for the CPG since more than 170 were identified during the systematic literature search, which was the primary basis for determining the aggregate level of evidence supporting each of the guideline KAS recommendations. Additional background evidence included RCTs and observational studies, as needed, to supplement the systematic reviews or to fill gaps when a review was not available. Therefore, in total, the evidence supporting this guideline, derived from the searches, includes 126 systematic reviews/meta-analyses, 107 randomized control trials, 8 guidelines, 6 umbrella reviews, 55 observational studies and other studies or resources, and 14 additional review resources/recommendations derived from consensus statements, position statements, and the American Diabetes Association Standard of Medical Care in Diabetes.

Classification of Evidence-Based Statements

The goal of this guideline is to optimize health outcomes, minimize harm, and align clinical care approaches. As this guideline was developed using an evidence-based approach, peer-reviewed published literature was identified, assessed, and summarized in the evidence profile linked to each KAS. These KAS recommendations reflect both the grade (level) of aggregate evidence and the balance of benefit and harm that is anticipated when the statement is implemented by the clinician. Table 5 defines the grades of aggregate evidence, ⁹⁷ and Table 6 defines the strength of action (obligation) based on the interaction of grade and benefit-harm balance. ⁹⁸ The evidence could be downgraded based on study risk of bias, imprecision, indirectness (different study population or question than guideline), inconsistency between studies (heterogeneity), or effects of small or questionable clinical importance. Conversely, the evidence could be upgraded if there was a large or very large effect size, or, in some cases, based on systematic reviews of observational studies.

Table 5.

Aggregate Grades of Evidence by Question Type. ^a

Grade	Level	Treatment	Harm	Diagnosis	Prognosis
A	1	Systematic review c of randomized trials	Systematic review c of randomized trials, nested case-control studies, or observational studies with dramatic effect c	Systematic review c of cross-sectional studies with consistently applied reference standard and blinding	Systematic review c of inception cohort studies b
B	2	Randomized trials, or observational studies with dramatic effects or highly consistent evidence	Randomized trials, or observational studies with dramatic effects or highly consistent evidence	Cross-sectional studies with consistently applied reference standard and blinding	Inception cohort studies b
C	3-4	Non-randomized or historically controlled studies, including case-control and observational studies	Non-randomized controlled cohort or follow-up study (post-marketing surveillance) with sufficient numbers to rule out a common harm, case-series, case-control, or historically controlled studies	Non-consecutive studies, case-control studies, or studies with poor, non-independent, or inconsistently applied reference standards	Cohort study, control arm of a randomized trial, case series, or case-control studies, or poor-quality prognostic cohort study
D	5	Case reports, mechanism-based reasoning, or reasoning from first principles
X	n/a	Exceptional situations where validating studies cannot be performed and there is a clear preponderance of benefit over harm

Abbreviations: n/a, not applicable; OCEBM, Oxford centre for evidence-based medicine.

^aAdapted from Howick and colleagues. ⁹⁷

^bA group of individuals identified for subsequent study at an early, uniform point in the course of the specified health condition, or before the condition develops.

^cA systematic review may be downgraded to level B because of study limitations, heterogeneity, or imprecision.

Table 6.

Strength of Action Terms in Guideline Statements and Implied Levels of Obligation.

Statement	Definition	Implied Obligation
Strong recommendation	A strong recommendation means the benefits of the recommended approach clearly exceed the harms (or that the harms clearly exceed the benefits in the case of a strong negative recommendation) and that the quality of the supporting evidence is excellent (grade A or B). a In some clearly identified circumstances, strong recommendations may be made based on lesser evidence when high-quality evidence is impossible to obtain (grade X) and the anticipated benefits strongly outweigh the harms.	Clinicians should follow a strong recommendation unless a clear and compelling rationale for an alternative approach is present.
Recommendation	A recommendation means the benefits exceed the harms (or that the harms exceed the benefits in the case of a negative recommendation), but the quality of evidence is not as strong (grade B or C). a In some clearly identified circumstances, recommendations may be made based on lesser evidence when high-quality evidence is impossible to obtain (grade X) and the anticipated benefits outweigh the harms.	Clinicians should also generally follow a recommendation but should remain alert to new information and sensitive to patient preferences.
Option	An option means that either the quality of evidence that exists is less robust (grade C or D) a or that well-done studies (grade A, B, or C) a show little clear advantage to one approach vs another.	Clinicians should be flexible in their decision-making regarding appropriate practice, although they may set bounds on alternatives. Patient preference should have a substantial influencing role.

^aAdapted from the classification scheme of the American Academy of Pediatrics. ⁹⁸ Table 5 provides definitions of evidence grades.

Development of Key Action Statements (KASs)

KASs were developed using the 3 literature searches and an assessment of the published evidence, identified in the searches, which was distributed to the GDG after the first conference call. The GDG proposed topics for developing KASs within the scope of the guideline, driven by the evidence, their clinical expertise, and perceived gaps in clinical care. The initial topic list was limited to issues that could be tied to a specific quality improvement opportunity and was then refined and released for review to the ACLM Board of Directors (BOD). Quality improvement opportunities were based on the 6 priorities highlighted in the National Quality Strategy, ⁹⁹ which include safety, engaging patients, coordination of care, promoting effective prevention/treatments, community engagement, and affordable quality care.

The resulting topics gathered from both the GDG and the ACLM BOD were ranked for perceived importance by all GDG members, with special relevance to the stakeholder group they represented. In total, 139 topics were identified and ranked prior to the first in-person meeting. At the first in-person GDG meeting, a transparent a priori protocol, ⁴³ was used for creating actionable KAS recommendations based on supporting evidence and the associated benefit and harm ratio. The recommendation statements were prioritized based on the GDG rankings of quality improvement topics and organized to mimic the flow of a patient encounter. Electronic decision support (BRIDGE-Wiz, Yale Center for Medical Informatics, CT) software was used to facilitate creating action statements and the related evidence profiles.^43,100 The strength of recommendation was constrained by the relationship of aggregate evidence grade (based on GDG consensus regarding the studies used to support a given KAS) and the benefit vs harm balance that would be anticipated if the KAS was followed, based on our assessment of, and confidence in, the supporting research evidence (Figure 1).

Figure 1.

Criteria for determining recommendation strength. The recommendation strength for a key action statement is determined by the aggregate evidence grade and the benefit vs harm relationship (e.g., preponderance vs balance). For some combinations with a preponderance of benefit or harm the guideline development group can choose between 2 possibilities (e.g., for evidence grades B, C, and X).

Once the KASs were derived, the GDG discussed the recommendations and the strength of evidence. The KASs are followed by action statement profiles and specified in the guideline protocol. ⁴³ Each KAS was assigned to at least 2 GDG members to develop the supporting and clarifying text, one serving as primary author and the other serving as the secondary author. The final KASs were compiled for review and an assessment of aggregate evidence levels and recommendation strength by the GDG.

To ensure accuracy in assessing the evidence, an unaffiliated ACLM consultant, with master’s level training in epidemiology, reviewed each individual reference cited in the KASs to ensure the accuracy of citations and the aggregate strength of evidence. Extracted data included study design, outcomes, statistical significance, effect size, limitations, generalizability, and consistency. These data were used to review the strength of evidence and strength of recommendations developed by the GDG. The GDG provided input and approved this aspect of the method to achieve consensus on how to develop strength of recommendations. In addition, the consultant reviewed all citations in the text to ensure proper alignment with evidence from the corresponding citation in the reference list. Two team members (KS and MK) further reviewed the data extracted from references by the consultant and confirmed limitations, consistency of evidence, and the aggregate evidence quality (strength) assigned by the GDG for each KAS in the accompanying profile. Final assessments of aggregate evidence quality (strength) were found to be supported by the studies cited and no changes were required.

The draft guideline underwent Guideline Implementability Appraisal (GLIA), by 3 staff members not involved in the guideline development process, to assess the clarity of the recommendations, adherence to methodologic standards, and potential barriers to implementation. ¹⁰¹ A subsequent conference call with the GDG reviewed the GLIA recommendations and revised the CPG accordingly. The final draft of the guideline was revised based on comments received during the co-author editing period, multidisciplinary peer review, open public comment, and journal editorial peer review. The guideline will be reviewed 5 years following publication unless new evidence warrants an earlier review.

This CPG reflects the best judgment of the GDG based on the current best evidence and trustworthy guideline development standards. These guidelines should not replace professional judgment and should be incorporated at the discretion of the clinician while considering each unique clinical circumstance. It is expected that a “strong recommendation” will facilitate less variation in practice than a “recommendation,” while “options” are intended to allow for the most variability in clinical practice. ¹⁰² It remains the priority of the clinician to assess the needs and interests of all individuals and patients, to customize care accordingly, and to function within their practice scope and training, regardless of CPGs. The recommendations of this GDG are rooted in value judgments with the aim of improving health outcomes and reducing usage of T2D medications when appropriate. Primarily, the GDG aimed for transparency in the process of creating and documenting KAS.

Financial Disclosure and Conflicts of Interest

The ACLM funded the development of this guideline in full, including meeting and travel expenses. Members of the GDG declared perceived conflicts of interest from the past 2 years, and these conflicts were shared across the group. Conflicts of interest included financial relationships, personal experiences, work/employment situation, and any previously established “stake” in a topic. ¹⁰³ It was determined that individuals with potential conflicts could remain in the GDG if the following criteria were met: (1) they reminded the panel of potential conflicts before discussion related to their conflict, (2) they recused themselves from discussions related to their conflict if requested by the panel, and (3) they agreed not to discuss the guideline in any way with industry prior to publication. ¹⁰⁴ Conflicts were reviewed at the start of each conference call and in-person meeting with the same process followed for perceived conflicts as described above. All conflicts are disclosed at the end of this document.

Key Action Statements (KASs)

Each evidence-based statement is organized as follows: a KAS in bold, followed by the strength of the recommendation in italics. Each KAS is followed by the ‘action statement profile’ detailing the quality improvement opportunities, aggregate evidence quality, level of confidence in the evidence (high, medium, low), benefits, harms, risks, costs, and a benefits-harm assessment. Statements of value judgments, the role of patient (person, individual) preferences, clarification of any intentional vagueness by the panel, exceptions to the statement, differing opinions, and implementation considerations are included for each KAS. Discussed in greater detail below is an assessment of the evidence base for each KAS. Please see Table 7 for an overview of each evidence-based statement in this guideline and Figure 2 for their interrelationships.

Table 7.

Summary of Guideline Key Action Statements.

Statement	Action	Strength
KAS 1: Advocacy for lifestyle interventions	The clinician or HCP should be an advocate for lifestyle interventions as first-line management for prediabetes and T2D, including restorative sleep, stress management, adequate physical activity, positive social connections, a whole-food, plant-predominant eating plan, and avoiding risky substances.	Strong recommendation
KAS 2: Assessment of baseline lifestyle habits	The clinician or health care professional should assess the baseline lifestyle habits, in adults with prediabetes, T2D or a history of GDM with regards to the 6 pillars of lifestyle medicine (see Table 2), educate the individual regarding opportunities to improve their lifestyle behaviors, and evaluate the individual’s readiness to change.	Strong recommendation
KAS 3: Establishing priorities for lifestyle change	For an adult with prediabetes, T2D, or a history of GDM, the clinician or HCP should establish priorities for lifestyle change with regards to the 6 pillars of lifestyle intervention (see Table 2) through shared decision-making and should discuss the role of using SMART (Specific, Measurable, Achievable, Relevant, And Time-Bound) goals in supporting positive lifestyle change.	Strong recommendation
KAS 4: Prescribing aerobic and muscle strength physical activity	The clinician or HCP should prescribe physical activity, with an emphasis on aerobic and muscle strength training, by establishing SMART goals and using the FITT (frequency, intensity, time, type) framework for implementation for adults with prediabetes, T2D, or a history of GDM.	Strong recommendation
KAS 5: Reducing sedentary time	The clinician or HCP should prescribe physical activity to reduce sedentary time, using SMART goals, for adults with prediabetes, T2D, or a history of GDM.	Strong recommendation
KAS 6: Identifying sleep disorders	In adults with prediabetes, T2D, or a history of GDM, the clinician or HCP should ask about sleep quality, quantity, and patterns, determine if a sleep disorder is present, and refer, as indicated, for further evaluation and management. Sleep disorders associated with prediabetes, (T2D), and a history of GDM include, but are not limited to, obstructive sleep apnea, shift work sleep disorder, chronic insomnia, and short or long sleep duration.	Strong recommendation
KAS 7: Prescribing a nutrition plan for prevention	In adults with prediabetes, or a history of GDM, the clinician, HCP, or their designee, should prescribe a nutrition plan using SMART goals that is consistent with the individual’s cultural background and is framed in food-based advice regarding caloric intake, nutrient needs, and the importance of a whole-food, plant-predominant eating plan.	Strong recommendation
KAS 8: Prescribing a nutrition plan for treatment	The clinician, HCP, or their designee, should clarify with the person with T2D if their goal is to achieve T2D remission or T2D improvement and should prescribe a nutrition plan using SMART goals that is consistent with the person’s desired outcome(s), cultural background, and is framed in food-based guidance promoting appropriate energy intake, nutrient needs, and the benefits of a whole-food, plant-predominant eating plan.	Strong recommendation
KAS 9: Peer/familial support and social connections	The clinician or HCP should counsel adults with prediabetes, T2D, or a history of GDM regarding the importance of cultivating positive social connections provided by peers, family members, and/or other professionals trained in lifestyle change methods to achieve SMART goals and optimize glucose management.	Strong recommendation
KAS 10: Identifying need for psychological interventions	In adults with prediabetes, T2D, or a history of GDM the clinician or HCP should identify or refer to someone who can identify serious mental illness such as severe mood/affective disorders, anxiety disorders, or psychotic disorders. For individuals experiencing stress or symptoms of depression or anxiety, prescribe mindfulness-based, cognitive behavioral therapy (CBT), or CBT-based interventions to improve diabetes clinical outcomes.	Recommendation
KAS 11: Tobacco, alcohol, and recreational drugs	The clinician or HCP should assess adults with T2D for use of tobacco, alcohol, and other recreational drugs and should counsel them on how using these substances can adversely impact management of T2D.	Strong recommendation
KAS 12: Achieving person-driven, sustained positive behavior change	For adults with prediabetes, T2D, or a history of GDM, the clinician, HCP, or their designee, should help individuals achieve sustained, person-centered, positive behavior change using evidence-based approaches including, but not limited to, coaching, motivational interviewing, and cognitive behavioral therapy.	Strong recommendation
KAS 13: Establishing a plan for continuity of care	For adults with prediabetes, T2D, or a history of GDM, the clinician or HCP should establish a plan for continuity of care that prescribes lifestyle interventions and specifies the frequency of visits, anticipated duration of care, potential need for adjustments of pharmacologic therapy, and expectations regarding the individual’s engagement.	Strong recommendation
KAS 14: Adjusting pharmacologic therapy	For adults with prediabetes, T2D, or a history of GDM, the clinician or HCP should adjust the type and dosing of an individual’s pharmacologic therapy based on the impact of lifestyle intervention on their medication needs.	Recommendation

GDM, gestational diabetes mellitus; HCP, healthcare professional; KAS, key action statement; T2D, type 2 diabetes.

Figure 2.

Flowchart showing the interrelationships of the guideline key action statements (KAS), with the numbering for each KAS corresponding to its order in the text.

In this guideline, “shared decision-making” is defined as the exchange of information regarding treatment risks and benefits, as well as the expression of patient preferences and values, which result in mutual responsibility in decisions regarding treatment and care. ¹⁰⁵ Shared decision-making (SDM) allows for collaboration between the individuals and clinicians and is particularly useful when evidence on a topic is relatively weak or if the benefits of a recommendation are not clear. Patient preference including, but not limited to, absolute benefits (numbers needed to treat), adverse effects (number needed to harm), cost of medications or procedures, and frequency and duration of treatment should be discussed and considered.

KAS 1: Advocacy for Lifestyle Interventions

The clinician or HCP should be an advocate for lifestyle interventions as first-line management for prediabetes and T2D, including restorative sleep, stress management, adequate physical activity, positive social connections, a whole-food, plant-predominant eating plan, and avoiding risky substances. Strong recommendation based on RCTs, systematic review, and observational studies with a preponderance of benefit over harm.

Action Statement Profile

• • Quality improvement opportunity: To advocate for, and raise awareness of, lifestyle interventions as first-line management for prediabetes and T2D. (National Quality Strategy Domain: Person- and Family-Centered Care; Prevention and Treatment of Leading Causes of Morbidity and Mortality)

• • Aggregate evidence quality: Grade A, for the benefits of lifestyle interventions, based on 5 meta-analyses and systematic reviews and 3 CPGs; Grade B, for the importance of advocacy based on observational studies

• • Level of confidence in evidence: High

• • Benefits: Raising awareness of lifestyle interventions, self-management skills for patients, and their efficacy; increasing access to evidence-based care; promoting shared decision-making; empowering individuals to take control of their health; drawing explicit attention to an aspect of diabetes management that may be overlooked or underappreciated by clinicians or health professionals, specifically lifestyle behaviors and associated factors; articulating the 6 pillars of lifestyle medicine with supporting evidence for benefiting adults with diabetes; facilitating the translation and implementation of public health knowledge into public health messaging; shifting the paradigm of diabetes management from pharmacological therapy to lifestyle interventions

• • Risk, harm, cost: Improper advocacy could stigmatize the individual or create animosity; miscommunication could lead to unrealistic expectations about the benefits of lifestyle interventions; inadequate resources to support advocacy could lead to dissatisfaction; overemphasis of lifestyle interventions could undermine or trivialize the role of pharmacological management in cases where needed

• • Benefit-harm assessment: Preponderance of benefit over harm

• • Value judgments: There is a perception among the GDG that in many healthcare settings, the lifestyle interventions are not discussed in the context of primary management, but often described in very general terms, or as an adjunct to pharmacological interventions

• • Intentional vagueness: The word “advocate” is used in the broad context of actively supporting, promoting, or arguing in favor of lifestyle interventions, which may include speaking out or taking action to influence others and bring about positive change

• • Role of patient (individual) preferences: Limited role, but individual may decline advocacy

• • Exceptions: None

• • Differences of opinion: None

• • Implementation considerations: Language and cultural barriers; facilitating clinicians or HCPs who may not personally be sufficiently knowledgeable about or embrace these lifestyle interventions to advocate them for individuals; time constraint on the clinician or health care professional that may not be compensated for by the insurance provider

Supporting Text

The purpose of this statement is to provide a context for clinicians or HCPs to recognize the need for advocacy regarding lifestyle interventions as the first line of management for prediabetes and T2D, including restorative sleep, stress management, adequate physical activity, positive social connections, avoiding risky substances, and a whole-food, plant-predominant eating plan. Clinical trials, systematic reviews, and observational studies show that these multifactorial lifestyle interventions as warranted are important considerations in the management of prediabetes and T2D and should be the first line of management before drug therapy commences for both prediabetes and T2D.

Although eating plans, specifically whole-food, plant-predominant eating plans, and physical activity are primarily highlighted in CPGs for prediabetes and T2D in Europe, the UK, and the United States,^{37,38,106-110} clinicians and other health care professionals must be aware of additional lifestyle factors that are not only relevant, but are also key frontline approaches to patient care. Lifestyle interventions prevent or delay progression to T2D in prediabetes and improve glycemic and associated outcomes such as deprescription of drugs and decreasing the likelihood of complications in T2D.^18,111-114 In addition, lifestyle intervention research studies show meaningful benefits for both direct and indirect medical costs due to less medication, a reduced need for professional and expensive health professional care, fewer diabetes complications, and improved work productivity.^22,91-93,96

Lifestyle interventions for adults with prediabetes and T2D that address all 6 pillars (Table 2) can impact the success of individuals in achieving desired clinical and personal outcomes for prediabetes and T2D management, including remission. For example, sleep duration and quality has been consistently shown to be associated with hemoglobin A1c (HbA1c) and other metabolic parameters indicative of diabetes management in systematic reviews of randomized control trials and epidemiological studies.^115,116 Additionally, a prediabetes or even T2D diagnosis can result from or be associated with increased stress. Therefore, it has been shown that stress management in a variety of person-specific or person-centered ways can help to ameliorate some of the diabetes-related negative symptoms, for example, glycemic/metabolic control and indeed control or prevent progression to T2D for those with prediabetes.^117-120

Social connectivity is an important pillar of lifestyle medicine that warrants strong consideration in diabetes care. For example, family, community, faith-based, workplace, and other groups play a critical role in adherence to and reinforcement of or failure to conform to key lifestyle behaviors such as eating plan and physical activity mentioned above that have been shown to be beneficial in delaying or preventing progression of prediabetes to T2D and achieving remission or better management of T2D. A systematic review ¹²¹ of RCTs that explored the effect of social network interventions showed improved social support and HbA1c after 3 months, confirming that social networking can promote meaningful clinical changes for adults with T2D. Similarly, a survey ¹²² of university employees with prediabetes enrolled in a behavior-change program for 3 months found that social and external support, in addition to high motivation, was critical in frontline and continued management strategies to enhance the success of the individual. Although data are limited, this aspect of diabetes self-management success is clearly relevant.

Risky behavioral practices such as smoking, alcohol, drug (illicit, recreational, and indiscriminate use of prescription drugs) are all regarded as potentially harmful, especially to adults with prediabetes or T2D. Speculation that smoking cessation can enhance appetite, and therefore risk of prediabetes and T2D, has been disproven in a study of Swiss adults, aged 35 to 75 years. ¹²³ Moreover, substance use (e.g., alcohol, smoking, and drugs) are associated with serious conditions including heart disease, cerebrovascular disease, some cancers, mental health conditions, road trauma, and domestic violence. ¹²⁴ Alcohol and drug use are also associated with diabetes incidence and the development of diabetes-related complications. Therefore, if identified upon diagnosis of either prediabetes or T2D, modification of these behaviors is integral to the frontline lifestyle behavior plan for individual self-management and improving outcomes.

Adherence to this KAS can be documented in the electronic health record, if possible, using check boxes or a standard field. Alternatively, the accompanying handout for individuals (Figure 3) developed for this purpose can be shared with the individual with documentation in the EMR that the information was provided and discussed, with appropriate counseling.

Figure 3.

Handout for Individuals 1: Advocacy for Lifestyle Interventions in Preventing and Managing Type 2 Diabetes in Adults.

KAS 2: Assessment of Baseline Lifestyle Habits

The clinician or health care professional should assess the baseline lifestyle habits, in adults with prediabetes, T2D or a history of GDM with regards to the 6 pillars of lifestyle medicine (See Table 2), educate the individual regarding opportunities to improve their lifestyle behaviors, and evaluate the individual’s readiness to change. Strong recommendation based on RCTs, systematic review, and observational studies with a preponderance of benefit over harm.

Action Statement Profile

• • Quality improvement opportunity: To set the stage for implementing lifestyle interventions for T2D. (National Quality Strategy Domain: Person- and Family-Centered Care; Prevention and Treatment of Leading Causes of Morbidity and Mortality)

• • Aggregate evidence quality: Grade A, based on 2 systematic reviews and 14 RCTs on the effectiveness of using education, coaching, and motivational interviewing in managing adults with prediabetes and T2D.

• • Level of confidence in evidence: High

• • Benefits: Establishing a baseline; raising awareness; gaining insights into the individual’s understanding and self-awareness of their lifestyle habits; identifying areas for improvement; promoting individual awareness of opportunities for improvement; individual empowerment; setting the stage for goal setting; enhancing individual understanding regarding the validity and credibility of lifestyle interventions; prioritizing lifestyle change; supporting the willingness of the individual to consider moving forward with lifestyle change; guiding the action plan for implementing lifestyle change; alerting the clinician or HCP to prior efforts of unsuccessful change and barriers to change; personalizing the approach to the individual; and setting the stage for true shared decision-making

• • Risk, harm, cost: Individual anxiety or sense of stigma, shame, and judgment by the clinician or HCP; blame, embarrassment, or both; time burden involved in assessment

• • Benefit-harm assessment: Preponderance of benefit over harm

• • Value judgments: There is a perception among the GDG that these fundamental issues of implementing lifestyle interventions are not routinely assessed in clinical care, and that many clinicians or HCPs are unaware of how to efficiently assess lifestyle interventions and readiness for change

• • Intentional vagueness: The specific methods for assessment are up to the clinician or provider, recognizing that the principle of doing this is more important than the specific practices used, and that validated tools are preferred when available

• • Role of patient (individual) preferences: Limited

• • Exceptions: None

• • Differences of opinion: None

• • Implementation considerations: Tools and materials to perform the tasks of assessing lifestyle behaviors and assessing readiness for change; trying to implement these tools and materials into integration into the electronic health record; integration of tools and materials into office flow; harmonization across different electronic health records

Supporting Text

The purpose of this statement is to provide a framework for clinicians and health care professionals to pragmatically assess baseline lifestyle habits, educate individuals about opportunities to improve their behaviors, and personalize the delivery of this content in a way that facilitates action steps towards improved health behaviors and sustainable change. A baseline assessment of lifestyle habits is necessary to highlight domains individuals are doing well in and to identify areas that could be improved. This can be accomplished by using a general lifestyle medicine screening tool, a detailed domain-specific questionnaire, or inquiring about the pillars as they relate to the visit focus. Validated questionnaires are ideally used, though clinically relevant and practical approaches can be utilized as appropriate.

The Lifestyle Medicine Assessment ¹²⁵ uses 21 items, addressing the 6 lifestyle pillars (Table 2), to identify modifiable behaviors that impact morbidity or mortality. This tool provides domain-specific and an overall lifestyle score that can be tracked over time and used to efficiently identify domains that may be most impactful in improving health. Another commonly used tool that evaluates lifestyle behaviors globally is the Loma Linda University Short Form, ¹²⁶ (a two-page form collects information about an individuals’ behaviors across 6 lifestyle domains (Table 2) and queries an individual’s motivation and overall health. The LLU Short Form is based on the LLU Long Form, which provides a more in-depth assessment, covering other medical symptoms and medical history components as well. ¹²⁷

Once specific areas are identified using a global assessment measure, domain-specific questionnaires (Table 8) can be used for more in-depth baseline assessment or for follow-up. Understanding the impact of social determinants of health (SDoH) is integral to this process to understand the individual’s resources, context, and abilities to make lifestyle changes, ¹²⁸ and can be assessed using the American Academy of Family Physicians Social Needs Screening Tool. ¹²⁹ Considering the importance of SDoH, because of concerns regarding the ability of lifestyle medicine to address broader SDoH beyond the 6 pillars listed in Table 2 and their corresponding assessment tools (See Table 8), SDoH factors such as education, access to parks, racism, and discrimination are recognized by only 50% to 60% of family physicians when surveyed, whereas factors like tobacco, alcohol, and access to healthy food are appreciated by over 80%. ¹³⁰

Table 8.

Recommended Lifestyle Medicine Tool Examples by Domain.

Lifestyle Medicine Domain	Brief Assessment or Screening Tool (Items), Best Suited for Clinical Practice	In-Depth Assessment (Items) for Research or Clinical Practice
Global screen	Lifestyle Medicine assessment, 125 Loma Linda University Short Form (20 items) 126	Loma Linda University Long Form (150+ items) 127
Avoidance of risky substances	Alcohol Use Disorders Identification Test (AUDIT-C), 131 NIDA Quick Screen (4 items) 132	AUDIT (10 items), 131 NIDA Modified Assist (8 items) 132
Nutrition	ACLM Diet Screener, 133 Starting the Conversation (8 items) 134	Automated Self-administered 24-Hour Recall, 135 Food diaries, Food frequency questionnaires
Physical activity	Exercise Vital Sign (EVS), 136 Physical Activity vital sign (PAVS) (2-3 items) 137	International Physical Activity questionnaire (7 items), 138 Physical Activity scale for the Elderly 139 (10+ items)
Positive social connection	A Brief Measure of Social Support (27 items) 140
Sleep	Single Sleep Quality Scale (1 item), 141 Patient-Reported Outcomes Measurement Information System (PROMIS) 142	Pittsburgh Sleep Quality Index (10-24 items) 143
Stress or depression	Perceived Stress Scale (PSS) (4 items), 144 Patient Health Questionnaire (PHQ) (2 items) 145 (depression), Generalized Anxiety Disorder (GAD) (2 items) 146	PSS (10 items), 147 PHQ-9 (9 items) 148 (depression), GAD-7 (7 items) 149

The baseline assessment can highlight opportunities for clinicians and health professionals to educate individuals on how they can improve their health. For example, multiple RCTs and a systematic review show improved HbA1c levels in prediabetes and T2D using self-care education approaches.^150-154 Tailoring education to individuals with T2D can also improve HbA1c^155-160 with significantly more weight loss and lower HbA1c levels when coaching programs are utilized.^161-163 The positive impact of health coaching on improvements in HbA1c and greater weight reduction has been demonstrated in lower-socioeconomic populations as well. ¹⁶⁴

Assessing the individual for readiness to change and the subsequent approach to behavior change should be motivating, collaborative, and individualized. Motivational interviewing is the most common framework to deliver behavior change and a systematic review of RCTs found it to be effective in improving HbA1c, postprandial plasma glucose, and systolic blood pressure in individuals diagnosed with diabetes. ¹⁶⁵ Motivational interviewing is often combined with the Transtheoretical Model of Change or Stage of Change model ¹⁶⁶ framework to match interventions to an individual’s current stage of change. ¹⁶⁷ It also utilizes tools such as the readiness to change ruler to aid in individual behavior change. ¹⁶⁸ These approaches can all be used to help deliver personalized, culturally sensitive, care to people with prediabetes and T2D.

Adherence to this KAS is best documented by including the assessment tools and results in the individual’s health record. Promoting health behavior change can be facilitated using a variety of techniques (See Figure 4 for an Infographic on MI/OARS/RULERS). Readiness to change can be documented through discussion or by including the results of a readiness to change ruler (See Figures 5 and 6) in the health record. Additionally, any discussion regarding the educational implications of the baseline assessment, and opportunities for behavior change, should be documented in the individual’s health record by the clinician, HCP, or another member of healthcare team.

Figure 4.

Infographic on MI/OARS/RULERS and behavioral change techniques: motivational interviewing (MI) and open questions, affirmations, reflective listening, and summary reflections (OARS).

Figure 5.

Adapted FAQ ruler for assessing and documenting individual readiness to change.^169-172

Figure 6.

Flow chart showing how motivational interviewing, open questions, and readiness to change are integrated into the dynamic process of behavior change.

KAS 3: Establishing Priorities for Lifestyle Change

For an adult with prediabetes, T2D, or a history of GDM, the clinician or HCP should establish priorities for lifestyle change with regards to the 6 pillars of lifestyle intervention (See Table 2) through shared decision-making and should discuss the role of using SMART (Specific, Measurable, Achievable, Relevant, And Time-Bound) goals in supporting positive lifestyle change. Strong recommendation based on RCTs, systematic review, and observational studies with a preponderance of benefit over harm.

Action Statement Profile

• • Quality improvement opportunity: To establish the individual’s priorities for lifestyle change using SMART goals and shared decision-making with regards to the 6 pillars of lifestyle intervention (National Quality Strategy Domain: Person- and Family-Centered Care; Effective Communication and Care Coordination; and Prevention and Treatment of Leading Causes of Morbidity and Mortality)

• • Aggregate evidence quality: Grade B, based on 6 observational studies, 6 RCTs, 2 cluster randomized trials, and 8 systematic reviews of RCTs

• • Level of confidence in evidence: High

• • Benefits: Facilitates individual engagement, empowerment for change, and buy-in; ensures that interventions align with the individual’s priorities; establishes structure and accountability for a more comprehensive plan; reassures the individual that there will be specific tailored advice to help them implement change; sets the stage for tailored SMART goals for specific behaviors related to individual lifestyle medicine pillars; establishes consistency in care; avoids non-specific prescriptive statements of “eat a healthy diet” and “exercise more” that rarely lead to sustained lifestyle change; informs the individual about how tailored goal setting will be created for lifestyle change; emphasizes the role of SMART goals in making lifestyle change more manageable, by emphasizing process not outcome (e.g., acknowledge progress); increases feasibility, accountability, and sustainability of change

• • Risk, harm, cost: Time in gathering information, time counseling individuals

• • Benefit-harm assessment: Preponderance of benefit over harm

• • Value judgments: There is a consensus among the GDG that the preferred way to implement lifestyle change is by using and tracking SMART goals; assumption that individuals are more likely to engage in and adhere to care plans when based on their priorities. The GDG has defined “SMART” goals in the action statement for alignment with Health and Wellness Coaching (HWC) of individuals, but recognizes that there are other variations on how specific letters of the acronym are defined

• • Intentional vagueness: None

• • Role of patient (individual) preferences: Little to none with regards to engaging in a discussion of priorities and SMART goals, but substantial role for shared decision-making in establishing and implementing SMART goals

• • Exceptions: None

• • Differences of opinion: None

• • Implementation considerations: Specific recommendations or informational materials on eliciting individual priorities; supporting materials for understanding SMART goals tailored to individuals, clinicians, and HCPs; potential for electronic health record integration

Supporting Text

The purpose of this statement is to ensure that clinicians and HCPs utilize SMART goal setting (Figures 7–9) and SDM when counseling and coaching people with prediabetes and T2D about behavior change. Telling people what to do, and demanding that they change is not motivating, nor is it effective behavior-change counseling. Coaching is a type of behavior-change counseling that focuses on the person as the expert in their own life and the HCP as a partner and collaborator who can help empower the person to adopt and sustain healthy lifestyle change. Healthcare professionals should partner with individuals through shared decision-making, give individuals autonomy, and work to co-create SMART goals that promote ownership over the change process. This partnership should recognize 3 innate psychological needs—relatedness, competence, autonomy—that, when satisfied, can enhance motivation and mental health. ¹⁷³

Figure 8.

Smart goals in action: examples of SMART goals and goals that are not in the SMART framework.

Figure 7.

Explanation of SMART goals.

Figure 9.

Worksheet for shared decision-making in implementing SMART goals for behavior change. The framework applies to all 6 pillars of lifestyle intervention, namely physical activity, nutrition, sleep, stress management, social connections, and avoidance of risk substances.

The person must be central to the clinical encounter and conversation when counseling on behavior change, ensuring bi-directional conversations. SDM, which is synergistic with the SMART framework, centers on understanding the person’s values, preferences, and context of life to integrate into the discussion with their clinicians to make a truly informed decision about their care plans. ¹⁷⁴ When compared to usual care for adults with T2D, based on standardized protocols, patient-centered care significantly lowers HbA1c, can reduce obesity, lowers cardiovascular risk, and significantly improves self-care behaviors.^175,176 Patient-centered care, in contrast to usual care, is culturally sensitive, is personalized to the individual’s values and preferences, and uses a holistic approach for multidisciplinary care based on the person’s emotional, social, and psychological needs.

It is important for the clinician or HCP to acknowledge the person’s expertise, with regards to their sense of purpose, priorities, vision for themselves, their values, and their daily responsibilities. These SMART goals should align with the person’s priorities and their values. Repeatedly setting SMART goals (e.g., weekly) helps individuals reach the vision they set for themselves for the future. A vision can be set for a year in the future or 5 years in the future. Setting SMART goals that help people fulfill their sense of purpose in life make the goals more compelling and inspiring (Figure 10).

Figure 10.

Ladder for coaching or counseling a person to continue to set new goals, which are like steps on a ladder to reaching their vision and purpose in life. The sides of the ladder are their priorities and their values. The SMART goals need to connect with the person’s priorities and values to be inspiring and motivating, using an iterative process that revisits the person’s mission in life. The SMART goals are how the person moves upward toward their healthiest self.

For people with prediabetes and diabetes, there are systematic reviews demonstrating that goal setting and SDM are effective strategies to empower discussions about lifestyle-centered strategies, improve the quality of decision-making, increase knowledge transfer, minimize decision conflict, and improve blood glucose levels and achieve recommended target HbA1c and fasting blood glucose at 6 months and 12 months follow-up.^177,178 SDM helps individuals achieve their target treatment goals. ¹⁷⁹ SDM and motivational interviewing sessions, followed by 7 biweekly telephonic coaching sessions, can significantly decrease diabetes distress and depressive symptoms in people with diabetes. ¹⁸⁰ Motivational interviewing, discussed in detail later in this guideline, enhances outcomes for adults with T2D when used in conjunction with SDM and patient-centered care.^181,182

Goal setting is a consistent element in research on diabetes coaching for individuals with T2D. ¹⁸³ Behavior-change techniques, such as goal setting, have been shown to reduce body mass index in people newly diagnosed with T2D ¹⁸⁴ and individualized goal setting and drug treatment lowers the risk of complications from diabetes. ¹⁸⁵ Goal setting can also help with changes in health behaviors, change in mindset or awareness, change in engagement with healthcare resources, change in physical and emotional health as well as change in health indicators. ¹⁸⁶ Additional research is required to further understand if a multiple-goal approach or a single goal-approach is more effective for individuals with T2D. ¹⁸⁷ Web-based interventions for individuals with T2D can facilitate goal setting. ¹⁸⁸ Wearable devices paired with goal setting can support behavior change in diabetes and are effective for improving glucose management.^189-191

Interventions using collaborative goal setting in diverse communities can improve self-efficacy, HbA1c, and glucose management. ¹⁹² For persons who identify as Black, there is a paucity of research with regards to the impact of SDM on outcomes, but SDM is most effective when based on humanistic communication (empathy, rapport, talking with people not against them), involvement of family members in decision-making, understandable medical information, and an open and direct approach from the clinician that fosters trust. ¹⁹³ SDM with individuals who have T2D has been evaluated and research supports varying approaches that include weighing alternatives, negotiating conflicting desires, and solving problems. ¹⁹⁴ More research is needed in this area to further identify how to personalize the process with cultural sensitivity, relevance, and humility.

There are few studies on goal setting and SDM for people with a history of GDM. Individuals with a history of GDM from minority groups rated goal setting for weight management as very or moderately helpful. ¹⁹⁵ For individuals with, or at risk for, GDM during pregnancy or postpartum, effective interventions were noted to include goal setting and individualized care. ¹⁹⁶

KAS 4: Prescribing Aerobic and Muscle Strength Physical Activity

The clinician or HCP should prescribe physical activity, with an emphasis on aerobic and muscle strength training, by establishing SMART goals and using the FITT (frequency, intensity, time, type) framework for implementation for adults with prediabetes, T2D, or a history of GDM. Strong recommendation based on RCTs and systematic reviews with a preponderance of benefit over harm.

Action Statement Profile

• • Quality improvement opportunity: To improve the person’s level of physical activity using the FITT framework for establishing SMART goals. (National Quality Strategy Domain: Person- and Family-Centered Care; Prevention and Treatment of Leading Causes of Morbidity and Mortality; and Making Quality Care More Affordable (compared to pharmacologic therapy))

• • Aggregate evidence quality: Grade A, based on 3 systematic reviews and meta-analyses, 2 RCTs, and 2 longitudinal cohort studies demonstrating the benefits of regular physical activity for individuals with dysglycemia

• • Level of confidence in evidence: High

• • Benefits: Improved glucose management, cardiorespiratory fitness, sleep quality, cognitive function, mental health, health-related quality of life (HRQOL), and cardiometabolic markers; assistance with stress and weight management; fewer major adverse cardiovascular events (MACE); decreased all-cause and diabetes-related mortality; less progression of sarcopenia, preserve lean muscle mass; reduced disability; improved resilience; reduced healthcare costs; enhanced bone health; increased adherence to physical activity recommendations

• • Risk, harm, cost: Injury from improper activity; hypoglycemia; compensatory overeating; individual frustration if unable to adhere to prescription (e.g., limited access to needed facilities); overexercise; ischemic and arrhythmogenic heart disease; cost of access to equipment, facilities

• • Benefit-harm assessment: Preponderance of benefit over harm

• • Value judgments: The GDG chose to emphasize aerobic activity and muscle strength training because they align with physical activity guidelines for Americans, and are most evidence-based, but also recognize that physical activity can include other modalities

• • Intentional vagueness: None

• • Role of patient (individual) preferences: Large role for shared decision-making in defining the optimal SMART goals

• • Exceptions: Those with physical limitations making it too uncomfortable, dangerous or impossible to increase physical activity as directed in the guidelines

• • Differences of opinion: None

• • Implementation considerations: Describing FITT paradigm; instructional materials for specific activities; referral information; access to facilities; promoting safety, cost, ease of documenting FITT framework and SMART goals in EHR

Supporting Text

The purpose of this statement is to highlight the importance of prescribing regular physical activity as part of a comprehensive approach to improving lifestyle behaviors and managing disease for people with prediabetes, T2D, and for individuals with a history of GDM. We recognize that some individuals with physical limitations or disabilities may be unable to adhere to all recommendations in this section and may therefore require additional evaluation or counseling when prescribing aerobic or muscle-strengthening activity (Table 9). ¹⁹⁷

Table 9.

Resources/Links/Videos Related to Physical Activity in Individuals With Limitations, Such as People With Amputations, Neuropathies, Mobility Restrictions, Etc.

Resources for Clinicians and Healthcare Professionals
Educating individuals to start exercising
Go4Life is based on studies that demonstrate the beneficial effects of exercise and physical activity for older people, including those with chronic health conditions.
Go4Life: The NIA health education campaign
https://www.nia.nih.gov/research/blog/2014/07/go4life-nia-health-education-campaign
While the resources were designed for older individuals, these can be SAFE and EASY to get started with younger individuals.
Introduction training—15 min
https://www.youtube.com/watch?v=Ev6yE55kYGw
Requires a chair and a towel
Safe including individuals who are chair bound or who have falls risk
Strength training—27 min
https://www.youtube.com/watch?v=JejTelL05Qw
More active participants
Upper and lower body—light weights—group based
Upper body resistance exercise
https://www.youtube.com/watch?v=pUYxcRvdal8
Hand grip—shoulder—arm curl—biceps curl with resistance bands
Wall pushups—chair dips—triceps
Lower body resistance exercise
https://www.youtube.com/watch?v=TOKxtgKrGCQ
back leg raise—side leg raise—chair stand—toe stand
Balance Initial exercise—stand on one foot
https://www.youtube.com/watch?v=QT5d4tTXW6U
Using a chair, first standing on 2 foot, then on one foot
Middle body exercise—heel-to-toe balance walk next to a wall
https://www.youtube.com/watch?v=z_GKdFf3qv4
Advanced—balance
https://www.youtube.com/watch?v=4YOBIEOobCE
Flexibility
https://www.youtube.com/watch?v=KcdkySvCRCc
Shoulder and upper arm stretch
Back stretch—ankle stretch—back of leg stretch—hip stretch—buddy stretch
PDF version of Exercise and Physical Activity: Your Everyday Guide from the National Institute of Aging at the National Institutes of Health 211
https://healthysd.gov/wp-content/uploads/2015/04/go4life-exercise-guide.pdf

Adapted from the Go4Life: the NIA health education campaign (National Institute on Aging, 2014) Exercise & Physical Activity: Your Everyday Guide from the National Institute on Aging (healthysd.gov). ²¹²

Regular physical activity is a main component of the National Diabetes Prevention Program, which includes individuals with prediabetes and a history of GDM. In the U.S. Diabetes Prevention multicenter trial, individuals meeting recommended physical activity levels had a 44% decreased risk of developing T2D independent of weight loss. ¹⁹⁸ Similarly, meeting physical activity recommendations reduces the risk of adults with T2D developing complications including heart disease, chronic kidney disease, and amputations.^199,200 Among U.S. adults aged 18 and older with diabetes, however, only 24.1% reported achieving the recommended 150 min per week of leisure time physical activity. ³ This reinforces the need for HCPs to take a more active role in assessing, promoting, and prescribing physical activity to individuals to help them meet the recommended 150-300 min of moderate-intensity aerobic activity and 2 muscle-strengthening activities per week (Figure 11). ²⁰¹

Figure 11.

Move your way physical activity guidelines for Americans (PAGA). Note that the guidelines include recommendations for both aerobic and muscle-strengthening activity. Department of Health and human services. Office of disease prevention and health promotion. Move your way. Walk. Run. Dance. Play. What’s your move? https://health.gov/moveyourway. ²⁰¹

The Physical Activity Vital Sign (PAVS), described in the American College of Sports Medicine’s (ACSM) Exercise Is Medicine™ (EIM) program, is a 2-item assessment tool, integrated into many electronic health records, prompting the healthcare team to assess and document minutes per week of moderate-to-vigorous physical activity. With this information, clinicians and HCPs can counsel and prescribe physical activity as part of a comprehensive disease prevention and management program. Another option for assessing physical activity with minimal administrative burden is the Exercise Vital Sign (EVS), ¹³⁶ a 2-item tool that is readily integrated with the electronic health record. A subgroup analysis of a systematic review and a meta-analysis of physical activity counseling in primary care found that 65.5% of people with diabetes received counseling compared to 37.9% overall. ²⁰² Information on the percentage of individuals who receive a written physical activity prescription is limited, but rates are considerably lower (by 3%-14%) than verbal advice. ²⁰²

There are 3 main components of the physical activity prescription (1) reducing sedentary time, (2) getting sufficient aerobic activity, and (3) engaging in muscle-strengthening activities. Notably, these 3 components are consistent with recommendations from the American Diabetes Association Standards of Care in Diabetes—2024 which advocate for breaking up prolonged sitting, moderate-to-vigorous aerobic activity, and muscle-strengthening. ¹¹⁰

Safety should first be determined using the ACSM’s Recommendations for Exercise Preparticipation Health Screening ²⁰³ to guide exercise intensity and progression (Figure 12). People with T2D who are currently exercising can continue with moderate-intensity physical activity, though should undergo medical clearance prior to engaging in vigorous intensity physical activity. Medical clearance is also recommended for people with diabetes who are not currently exercising prior to starting moderate or vigorous intensity physical activity. Notably, the person with known cardiovascular, metabolic (type 1 and T2D), or renal disease is recommended to seek medical clearance prior to initiating an exercise program. The HCP should decide what, if any, further evaluation is appropriate prior to the initiation of exercise. This can be as simple as a chart review or as thorough as formal cardiovascular testing (Figure 12). ²⁰³ Importantly, individuals may require additional modifications to their physical activity prescriptions to ensure it is feasible, acceptable, effective, and safe (Table 9).

Figure 12.

American College of Sports Medicine preparticiption health screening flowchart. The flowchart is used for determining safe exercise intensity and progression when prescribing physical activity for adults with type 2 diabetes. ²⁰³ ACSM-101-PrescreeningInfographicColorLegal-2015-12-15-V02).

Meeting aerobic activity guidelines can be accomplished with a wide variety of activities, the most common of which is walking. Brisk walking, which elevates heart rate and breathing, and allows for talking but not singing, is considered moderate intensity. Light-intensity walking and simple resistance activities (e.g., half squats, calf raises, knee raises), following meals and throughout the day for as little as 3 min, are also associated with improved glucose management in people with diabetes. ²⁰⁴ Following the ACSM’s Recommendations for Exercise Preparticipation Health Screening, people may advance to more vigorous intensity exercise (Figure 13). ²⁰³

Figure 13.

American College of Sports Medicine (ACSM) prepartipation screening algorithm. ^§Exercise participation, performing planned, structured physical activity at least 30 min at moderate intensity on at least 3 d·wk⁻¹ for at least the last 3 months. ^*Light-intensity exercise, 30% to <40% heart rate reserve (HRR) or vigorous oxygen uptake reserve (V˙O₂R), 2 to <3 metabolic equivalent of tasks (METs), 9-11 rate of perceived exertion (RPE), an intensity that causes slight increases in heart rate (HR) and breathing. ^**Moderate-intensity exercise, 40% to <60% HRR or V˙O₂R, 3 to <6 METs, 12-13 RPE, an intensity that causes noticeable increases in HR and breathing. ^***Vigorous-intensity exercise ≥60% HRR or V˙O₂R, ≥6 METs, ≥14 RPE, an intensity that causes substantial increases in HR and breathing. ^‡Cardiovascular disease (CVD), cardiac, peripheral vascular, or cerebrovascular disease. ^‡‡Metabolic disease, type 1 and 2 diabetes mellitus. ^‡‡‡Signs and symptoms, at rest or during activity; includes pain, discomfort in the chest, neck, jaw, arms, or other areas that may result from ischemia; shortness of breath at rest or with mild exertion; dizziness or syncope; orthopnea or paroxysmal nocturnal dyspnea; ankle edema; palpitations or tachycardia; intermittent claudication; known heart murmur; or unusual fatigue or shortness of breath with usual activities. ^‡‡‡‡Medical clearance, approval from a health care professional to engage in exercise. ^ΦACSM Guidelines, see ACSM’s Guidelines for Exercise Testing and Prescription, 9th edition, 2014.

Aerobic activity is most often prescribed using a FITT prescription. This should be co-created by the clinician or HCP and the individual, and tailored to fit the individual’s abilities, needs, and preferences. Frequency refers to the number of days per week an activity is performed. This can start out with a few days each week and should progress towards most days of the week. Intensity refers to the difficulty of exercise. For people just starting an exercise program, the following descriptions of exercise intensity may be helpful to guide their progression:

• • Light intensity: an intensity that causes slight increases in HR and breathing.

• • Moderate intensity: an intensity that causes noticeable increases in HR and breathing.

• • Vigorous intensity: an intensity that causes substantial increases in HR and breathing.

Time is the number of minutes of activity. While the Physical Activity Guidelines for Americans recommend 150-300 min of moderate-intensity aerobic activity per week or 75 min of vigorous intensity aerobic activity per week, there are no recommendations for “bout length,” meaning activity can be accumulated throughout the day or week in 5-, 10-, 30- or 60-min bouts, and can include a multitude of activities such as walking, dancing, or gardening. Shorter (3-5 min) bouts scattered throughout the day are sometimes referred to as exercise “snacks” or “bite-sized exercise” ²⁰⁵ (Figure 14). Similarly, there are several ways in which people can participate in vigorous intensity physical activity, including jogging, running, hiking uphill, or singles tennis; high-intensity interval training (HIIT); and “vigorous intermittent lifestyle physical activity (VILPA),” defined as brief and sporadic (up to 1-2 min) bouts of vigorous physical activity during daily living, (e.g., bursts of very fast walking or stair climbing).

Figure 14.

Breaking sitting streaks. Examples of how exercise “snacks” or “bite-sized exercise” regimens can be easily integrated into everyday activities by increased standing time and a few 2-to-3-minute exercise bursts throughout the day.

Compared to continuous moderate-intensity physical activity, participation in HIIT is associated with greater fitness and better glucose management in people with T2D; however, it has been found to increase the likelihood of adverse events, predominantly musculoskeletal injuries. ²⁰⁶ Type refers to the modality of exercise being performed, such as walking, jogging, biking, rowing, swimming, etc. Using the FITT principle (frequency, intensity, time, and type), the HCP can partner with the individual to customize the physical activity prescription. The Exercise Is Medicine™ Prescription Form (EIM) (Figure 15) can be used by HCPs to provide the individual with written information and guidance to start or increase their physical activity.

Figure 15.

Person-centered exercise form that can be used by clinicians and healthcare professionals to engage individuals in physical activity by prescribing goals using the FITT framework: frequency, intensity, time and type. American College of Sports Medicine. Exercise is medicine. Physical activity prescription form. https://www.exerciseismedicine.org/wp-content/uploads/2021/02/EIM-Prescription-2018-e-form.pdf. ²⁰⁷ Reproduced with permission from the American College of Sports Medicine.

Muscle strength training is the third leg of the physical activity prescription. The Physical Activity Guidelines for Americans recommend that adults participate in 2 sessions per week, focused on strengthening large muscle groups. ²⁰¹ Muscle strength training can be performed with exercise bands, body weight (e.g., pushups, planks, squats), using weight machines or free weights. Resistance training is demonstrated to improve muscle strength and insulin sensitivity and lower HbA1c in people with T2D. ²⁰⁶ Interventions that combine both aerobic and muscle strength training activities are superior to either alone in achieving improvements in fitness, body composition and glucose management. ²⁰⁶

Beyond aerobic fitness and muscle strength and endurance, the components of fitness include flexibility and balance, both of which may be impaired due to T2D and may be improved with regular physical activity. Activities such as yoga and Tai chi can improve joint mobility, balance, neuropathic symptoms, and quality of life; and reduce BMI, improve glucose management, and lower HbA1c levels. ²⁰⁶ These activities generally require a lower fitness level, no equipment, and are increasingly available through online sources and at no or low cost, reducing the barrier to participation for people with limited resources.

In summary, regular physical activity is a key component for preventing and managing T2D, with additional benefits from lowering diabetes-related complications, healthcare costs, and premature mortality. The PAVS^136,137 can be integrated into the electronic health record as a prompt to ask, document, and counsel individuals to integrate regular physical activity into their daily lives. Recommendations should include both aerobic and muscle strength training, while focusing on “move your way.”

Activity that is enjoyable, and done with others, is more likely to be sustained. Avoiding prolonged sedentary time and encouraging movement throughout the day has been shown to improve glucose management. ²⁰⁸ Resources from the American College of Sports Medicine and its Exercise Is Medicine program can support clinicians and HCPs in prescribing and assisting individuals engaging in regular physical activity.^206,209 Finally, it is important that clinicians and HCPs serve as active role models for individuals, colleagues, and communities, because as role models they are more likely to counsel individuals to engage in regular physical activity. ²¹⁰

KAS 5: Reducing Sedentary Time

The clinician or HCP should prescribe physical activity to reduce sedentary time, using SMART goals, for adults with prediabetes, T2D, or a history of GDM. Strong recommendation based on RCTs, systematic review, and observational studies with a preponderance of benefit over harm.

Action Statement Profile

• • Quality improvement opportunity: To reduce the person’s sedentary time using SMART goals to increase physical activity. (National Quality Strategy Domain: Person- and Family-Centered Care; Prevention and Treatment of Leading Causes of Morbidity and Mortality)

• • Aggregate evidence quality: Grade B, based on systematic reviews, meta-analyses, and RCTs on the effectiveness of using physical activity to reduce sedentary time in the management of prediabetes and T2D

• • Level of confidence in evidence: High

• • Benefits: Promote awareness of the adverse impact of sedentary activity; educate individuals about how even small levels of physical activity to interrupt sedentary time are beneficial; improve glucose management

• • Risk, harm, cost: None

• • Benefit-harm assessment: Preponderance of benefit over harm

• • Value judgments: Potential lack of awareness by clinicians and individuals of how harmful excessive sedentary time can be for T2D and overall health

• • Intentional vagueness: None

• • Role of patient (individual) preferences: Large role in agreeing upon action plan goals

• • Exceptions: None

• • Differences of opinion: None

• • Implementation considerations: Handouts for individuals on how to disrupt sedentary time in different environments (e.g., home, workplace)

Supporting Text

The purpose of this statement is to highlight the status of sedentary lifestyle habits that contribute to the high prevalence of T2D, prediabetes and GDM, and how that can be remedied by incorporating physical activity throughout the day. Although physical activity has been fully discussed in the prior KAS, our GDG considered it equally important to raise awareness of the detrimental effects of sedentary time, and the need to reduce or interrupt it, in addition to achieving adequate physical activity. This is consistent with recent global guidelines on targets to reduce sedentary behavior for adults. ²¹³

According to NHANES evaluation in adults sitting more than 6 hours per day has increased from 16.1% in 2007-2008 to 18.8% in 2015-2016. ²¹⁴ Device-based estimates of sedentary time are even higher varying from 7.7 h to 11.5 h per day. ²¹⁵ A sedentary time of more than 9.5 h per day results in a demonstrable increase in mortality; whereas a reduction of mortality is seen with higher levels of total physical activity and intensity. ²¹⁵ This is true for people with prediabetes and GDM, for whom there is an increased incidence of the development of T2D in the future.

Sedentary behavior is defined as any waking behavior characterized by an energy expenditure below 1.5 metabolic equivalents (METs), while sitting, reclining, or lying posture. ²¹⁶ Most desk-based office work, driving or riding in a car, and watching television are examples of sedentary behavior and can also apply to those unable to stand, such as wheelchair users. Accelerometer-based data derived from large or population-representative studies, indicate that adults spend approximately 8.2 h/day (range 4.9 – 11.9 h/day) sedentary. ²¹⁷

Leisure time sedentary behavior (TV watching) is associated with higher T2D prevalence, an effect mediated through higher BMI, higher triglycerides, as well as moderated through decreased levels of educational attainment. ²¹⁸ A systematic review ²¹⁹ found a conclusive deleterious association between not just sedentary behavior and T2D, but also insulin sensitivity, fasting insulin, 2-h insulin, and interleukin-6. Some studies in this review also found benefits reallocating sedentary behavior to light or moderate-to-vigorous physical activity for 2-h glucose, fasting insulin, insulin resistance (HOMA-IR), and insulin sensitivity.

An RCT of adults with obesity and T2D showed that frequent interruptions of prolonged sitting with 3 min of light-intensity walking breaks every 15 min improved fasting glucose, the dawn phenomenon, and night-time glycemic variability. ²²⁰ Another randomized, crossover trial in adults with overweight or obesity with medically controlled T2D showed that interrupting prolonged sitting with brief 6-min bouts of simple resistance activities every 60 min (like half squats or calf raises, etc.) reduced postprandial glucose and insulin response. ²²¹ The ADA guidelines suggest that brief activity should occur at least every 30 min to interrupt prolonged sitting. ²²²

The timing of physical activity in relation to meals can impact benefits for adults with T2D. ²²³ For example, light exercise, such as 20 min of walking, can benefit hyperglycemia after a meal when performed soon after eating. In contrast, exercise before eating does not reduce postprandial hyperglycemia. Current evidence, although not definitive, suggests that regular mild to moderate exercise shortly after, or directly following, a meal could have long-term beneficial effects on glycemic control.

Given the importance of reducing, or interrupting, sedentary time, concurrent with efforts to achieve adequate physical activity, the clinician or HCP should offer SMART goals to the individual to minimize the adverse health impact of sedentary time. Some examples include:

• • I will do some light walking for 3 min to interrupt my sitting time every 15 min for the next 4 weeks.

• • I will interrupt any prolonged sedentary time with 6 min of calf raises or half squats after every 60 min for the next 3 months.

• • I will take a 3 min break to stretch, walk, or climb some stairs, every 30 min if I find myself sedentary for more than 30 min during the next 2 months.

As noted previously, the specifics of the SMART goals or a FITT prescription should align with the individual’s abilities, purpose, and values to maximize adherence. Consideration should also be given to using a wearable activity tracker (e.g., pedometer, smart ring, smartphone), which was found in an umbrella review (review of systematic reviews) to be an appealing, low-cost tool for reducing inactivity, with average of daily gains of 1800 extra steps and 40 added minutes of walking. ²²⁴ Figure 16 demonstrates activities that individuals can utilize to break up sedentary time.

Figure 16.

Bite-sized exercise snacks. Examples of bite-sized activities that individuals can utilize to break up or reduce sedentary time.

KAS 6: Identifying Sleep Disorders

In adults with prediabetes, T2D, or a history of GDM, the clinician or HCP should ask about sleep quality, quantity, and patterns, determine if a sleep disorder is present, and refer, as indicated, for further evaluation and management. Sleep disorders associated with prediabetes, T2D, and a history of GDM include, but are not limited to, obstructive sleep apnea, shift work sleep disorder, chronic insomnia, and short or long sleep duration. Strong recommendation based on RCTs, systematic reviews, and observational studies with a preponderance of benefit over harm.

Action Statement Profile

• • Quality improvement opportunity: To identify individuals with sleep disorders and to optimize sleep behaviors. (National Quality Strategy Domain: Patient Safety, Person- and Family-Centered Care; Effective Communication and Care Coordination, Prevention and Treatment of Leading Causes of Morbidity and Mortality)

• • Aggregate evidence quality: Grade B, based on RCTs and systematic reviews with meta-analyses of both RCTs and observational studies indicating an association and examining management of prediabetes and T2D for delineated sleep disorders

• • Level of confidence in evidence: High

• • Benefits: Prioritize additional assessment and intervention of individuals who require further evaluation to improve sleep quality, avoid complications, or sequelae, of an underlying sleep disorder that may not have been previously recognized or diagnosed; better inform the management plan for diabetes mellitus by taking into account comorbid sleep disorders; raise awareness of optimal sleep duration and patterns for better disease-specific and overall health, providing information and strategies on how to improve sleep behaviors, avoiding lifestyle behaviors that could impair sleep patterns; offer specific, individualized advice acceptable to the individual and consistent with their values

• • Risk, harm, cost: Time counseling individuals; cost of additional assessment, testing, or referral; limited access to individuals who can perform the needed additional evaluations; frustration if unable to achieve goals

• • Benefit-harm assessment: Preponderance of benefit over harm

• • Value judgments: Importance of not missing a sleep disorder that requires special assessment or management, before proceeding with more standard recommendations on improving sleep quality and quantity

• • Intentional vagueness: None

• • Role of patient (individual) preferences: Limited, in terms of recognizing disorders

• • Exceptions: None

• • Differences of opinion: None

• • Implementation considerations: Table describing sleep disorders, their relevance to diabetes, and their implications; FAQs regarding how to optimize sleep duration and quality; education handouts for individuals; access to a sleep professional for referral; access to testing for a sleep study

Supporting Text

The purpose of this statement is to highlight the importance of obtaining information about sleep quality, quantity, and patterns in people with prediabetes, T2D, or a history of GDM. Poor sleep habits and sleep disorders are associated with a higher prevalence and incident risk of T2D and GDM, and worse glucose management in the setting of T2D. Several sleep disorders are considered here including obstructive sleep apnea (OSA), chronic insomnia disorder/insomnia symptoms/poor sleep quality, shift work disorder (SWD), and short and long sleep duration.

Obstructive Sleep Apnea

OSA is one of the most common sleep disorders characterized by recurrent upper airway collapse resulting in intermittent hypoxia and sleep fragmentation. The resultant pathophysiological consequences of OSA—including systemic inflammation, dysfunction of the hypothalamic-pituitary-adrenal axis, oxidative stress, and sympathetic neuronal activation—can disrupt glucose metabolism. The association between OSA and disorders of glucose metabolism has long been recognized.^225,226 Cross-sectional analyses and prospective, cohort studies have unequivocally demonstrated that untreated OSA is associated with prevalent prediabetes, ²²⁷ prevalent T2DM,^228,229 as well as incident diabetes with a linear, dose-dependent association described between OSA severity and the development of diabetes. ²²⁷ Additional analyses estimate the risk of T2D to increase by 8% for each 5-event/hour increase in the apnea-hypopnea index, the primary metric of OSA severity. ²³⁰

Despite strong evidence of the association between OSA and disorders of glucose metabolism, RCT’s assessing the treatment effects of positive airway pressure (PAP) therapy, the most common therapy for OSA, on glycemic outcomes has been equivocal. While some studies have shown a benefit of PAP therapy on glycemic outcomes in T2D,^231-233 others have not.^234-238 Meta-analyses from pooled data in people with T2DM is also mixed with some analyses showing no effect with PAP treatment in outcomes,^239,240 others showing a partial effect, ²⁴¹ and others showing clear improvement in glucose management.^242,243

The effect of PAP therapy on prediabetes appears to be more consistent across studies with pooled data showing that PAP therapy can help halt or reverse metabolic disturbances such as insulin resistance.^244,245 Potential reasons for the conflicted findings include duration of disease and adherence to therapy. A dose-response effect has been noted with PAP use and improvement in glycemic outcomes.^233,245 Furthermore, heterogeneity of disease (in both OSA and metabolic disorders) can impact outcomes. Emerging OSA phenotypes and endotypes may explain the variable response to therapy and inconsistencies in the existing literature. Sex-specific differences in glycemic outcomes with PAP therapy are also starting to become apparent, with improvements in glycemic outcomes noted in women.^234,237 Further research is needed to understand mechanisms underlying these differences.

The STOP-Bang questionnaire is widely validated as a simple, effective screening tool for OSA, with each letter corresponding to a question: Snoring, Tired, Observed (apnea, choking, gasping), Pressure (blood), BMI, Age, Neck size, and Gender. ²⁴⁶ A systematic review found that a STOP-Bang score of 3 or greater provides high sensitivity (over 90%) for detecting moderate-to-severe OSA, making it useful across various populations. ²⁴⁷ The questionnaire’s ease of use makes it valuable for early identification of individuals at-risk for OSA.

Shift Work Disorder (SWD)

About 20% of the workforce in industrialized nations are employed in shift work, defined as a job schedule other than the 9 am to 5 pm usual schedule. ²⁴⁸ Shift work disorder is a circadian rhythm disorder caused by the forced disruption of the normal sleep-wake cycle leading to circadian misalignment and sleep loss. The circadian timing system and its regulation are closely linked and critical to metabolic homeostasis. A mismatch in eating times with the normal biological clock, desynchronization between peripheral and central clock systems, alterations in neurohormones such as leptin, ghrelin, and melatonin, and changes in energy expenditure all contribute to decreased insulin sensitivity and increased postprandial glucose values in shift workers.^249,250

Shift work disorder is strongly associated with incident diabetes mellitus. A recent umbrella review ²⁵¹ of meta-analyses examining the association between shift work and several health outcomes found the strongest associations with shift work were myocardial infarction and T2D incidence, and other meta-analyses have noted an elevated 5-year exposure relative risk.^252,253 Additionally, the association between the type of shift work and diabetes is strongest for those doing rotating, evening, and night shifts.^69,253

Overall, the available data on a variety of therapies from clinical trials for SWD are promising but limited by small sample sizes and mixed results. Therapeutic interventions such as sleep hygiene education,^254,255 modifying meal composition during shift work ²⁵⁶ and restricting/changing timing of food intake during a shift ²⁵⁷ have been shown to have positive effects on glycemic outcomes or weight. ²⁵⁸ In contrast, limited evidence on the use of melatonin ²⁵⁹ or light therapy ²⁶⁰ in SWD suggests they are not associated with improvement in glycemic outcomes.

Insomnia

Chronic insomnia disorder, insomnia symptoms, and poor sleep quality are frequently reported in people with T2D or at risk for T2D. ²⁶¹ The measurement and reporting of sleep quality, insomnia symptoms, and chronic insomnia disorder varied considerably in the reviewed literature and ranged in rigor from asking a singular question about sleep initiation, sleep maintenance, or hypnotic drug use, to the use of validated questionnaires (e.g., PSQI, ISI, MOS-SS, AIS), and most strictly, the use of DSM-5 and International Classification of Sleep Disorders (ICSD) diagnostic codes. Nonetheless, the findings across multiple meta-analyses were consistent. First, the prevalence of insomnia symptoms was noted to be as high as 39% in those with T2D ²⁶² and was associated with worse glucose management.^115,262 Poor sleep quality, insomnia symptoms, and chronic insomnia disorder have also been shown to be associated with approximately a 30%-40% risk for developing T2D.^263,264 Further, there is a dose-response association between duration of insomnia and of the risk of developing T2D, ranging from 14% for duration under 4 years to over 50% when persisting over 8 years. ²⁶⁵

Clinical trials assessing interventions for insomnia and glycemic outcomes are limited but promising. Studies on sleep hygiene education, ²⁶⁶ and cognitive behavioral therapy for insomnia (CBT-I), show significant or positively trending improvements^266-270 in glycemic outcomes and even diabetes self-care behaviors.^267,269,270 Pharmacological interventions for insomnia symptoms such as melatonin, suvorexant, benzodiazepine receptor agonists have resulted in mixed effects on glycemic outcomes.^270,271 The insomnia subtype of short sleep duration (less than 6 h) is associated with a higher risk of T2D compared to insomnia disorder of normal sleep duration. ²⁷²

Sleep Duration

Short sleep duration is defined as less than 7 h of sleep per 24-h period, as per the Centers for Disease Control, ²⁷³ and it is recommended that adults sleep at least 7 h per night. ²⁷⁴ Reduced sleep duration can adversely impact insulin sensitivity and insulin resistance when assessed by Matsuda index ²⁷⁵ and on intravenous glucose tolerance testing (IVGTT).^275,276 Similarly, short sleep duration is associated with worse glucose management demonstrated by higher HbA1c and fasting plasma glucose levels in people with T2D. ¹¹⁵ Possible explanations for the association between sleep restriction and impairment of glucose metabolism include changes in appetite, caloric intake, and energy balance possibly through alterations in hormones such as leptin and ghrelin.^115,276 The impact of sleep extension on glucose metabolism, however, is uncertain because of studies with inconsistent results and with methodological limitations including heterogeneity of the intervention, study populations, and outcome measures.^270,275,276

Long sleep duration, defined as total sleep time of 8.5 h or more, is also associated with worse glucose management in people with T2D, indicating a U-shaped association between sleep duration and glucose management. ¹¹⁵ Mechanisms underlying the association, however, are not well elucidated. Finally, manipulation of sleep stages can impact glycemic outcomes, with slow wave sleep suppression resulting in reduced insulin sensitivity. ²⁷⁵

Sleep Health and Hygiene

Sleep disturbances occur commonly in people with T2D, and at risk for T2D, with a resulting impact that is comparable to that seen with traditional risk factors. ²⁶⁴ Identifying sleep disorders in people with prediabetes, T2D, or a history of GDM could mitigate progression to diabetes and/or diabetes-related complications. Even without a suspected or apparent sleep disorder, prioritizing sleep, in people with T2D or at risk for T2D, has significant value given that sleep is a pillar of health. Reviewing and optimizing sleep-related habits and hygiene should be considered for all people with or at risk for T2D as part of their T2D self-management education (Figure 17).

Figure 17.

Lifestyle sleep health: tips and guidelines for maintaining good sleep habits for better management of diabetes and prediabetes. Adapted from the following American Academy of Sleep Medicine resources: https://aasm.org/clinical-resources/patient-info/ and https://aasm.org/resources/pdf/products/howtosleepbetter_web.pdf.

KAS 7: Prescribing a Nutrition Plan for Prevention

In adults with prediabetes, or a history of GDM, the clinician, HCP, or their designee, should prescribe a nutrition plan using SMART goals that is consistent with the individual’s cultural background and is framed in food-based advice regarding caloric intake, nutrient needs, and a whole-food, plant-predominant eating plan. Strong recommendation based on RCTs and systematic reviews with a preponderance of benefit over harm.

Action Statement Profile

• • Quality improvement opportunity: To increase early nutritional interventions for people at risk of developing T2D using SMART goals (National Quality Strategy Domain: Person- and Family-Centered Care; Effective Communication and Care Coordination; Prevention and Treatment of Leading Causes of Morbidity and Mortality)

• • Aggregate evidence quality: Grade A, based on systematic reviews, meta-analyses, and RCTs on the effectiveness of using evidence-based strategies for implementing nutrition and food-based strategies for preventing T2D

• • Level of confidence in evidence: High

• • Benefits: Prevent progression of prediabetes to T2D, achieve normoglycemia in people with prediabetes, prevent recurrence of GDM, prevent progression of GDM to T2D, dispel nutrition myths and misinformation

• • Risk, harm, cost: Cost of food, a focus on weight loss could be problematic for someone with disordered eating behaviors, time counseling individuals

• • Benefit-harm assessment: Preponderance of benefit over harm

• • Value judgments: There is a perception among the GDG that a history of GDM is underappreciated as an opportunity for nutritional intervention to prevent recurrence or progression. Although the GDG recognizes that preventing T2D is the optimal goal for people at risk for T2D, not everyone may be willing to commit to the degree of intervention, and should this occur, a goal of improvement is reasonable. The GDG agreed that for T2D prevention, nutrition, and physical activity should be a frontline approach to treatment for prediabetes and are not always communicated and offered as a management option

• • Intentional vagueness: None

• • Role of patient (individual) preferences: Large role for shared decision-making, both in deciding upon the goals and in devising and implementing a culturally relevant acceptable action plan

• • Exceptions: None

• • Differences of opinion: None

• • Implementation considerations: Information about Diabetes Prevention Program; fact sheets; materials describing a whole-food, plant-predominant eating plan vs standard American diet; education materials on identifying ultra-processed foods; food preparation challenges; inadequate or no access to plant-based food options; inability to purchase healthier food options; preference for referral to registered dietitians and other team members who can assist with sustainable weight loss and educate individuals one-on-one, especially those with low literacy; need to modify EMRs to facilitate capturing information needed to show adherence to these lifestyle intervention recommendations and accompanying SMART goals

Supporting Text

The purpose of this statement is to provide practical and evidence-based strategies for implementing a whole-food, plant-predominant eating plan in treating prediabetes, and preventing prediabetes or GDM from progressing to T2D.

For many adults with prediabetes, or a history of GDM, early intervention is beneficial and important, rather than watching and waiting (e.g., with borderline HbA1c). A history of GDM increases the lifetime risk of developing T2D even though the blood glucose levels may come back to non-diabetes levels after the pregnancy ends. ²⁷⁷ Maternal GDM can also impact the child as an independent risk factor for increased BMI and obesity at 6-8 years of age.^278,279 Therefore, discussing healthy lifestyle choices is important at all life stages, as well as both during and after pregnancy for diabetes prevention. Most of the nutrition research related to diabetes prevention was completed in people with prediabetes and there is a need for more studies on diabetes prevention in individuals with a history of GDM.

The Diabetes Prevention Program (DPP), published in 2002, showed that intensive lifestyle intervention, which included 5% to 7% weight loss and 30 min of physical activity 5 days per week, could reduce the incidence of T2D by 58% over 3 years in adults with overweight or obesity and had impaired glucose tolerance, compared to metformin that reduced the incidence by only 31%. ¹⁴ In 2009, the DPP 10-year follow-up showed prevention or delay of diabetes with lifestyle intervention or metformin can persist for at least 10 years. ²⁸⁰ Originally, the DPP used a low-fat eating pattern to induce weight loss, but the program has expanded to include alternate calorie-controlled eating patterns that may align more with what the person at risk for diabetes is willing and able to do.

Eating Patterns and Food-Based Strategies for Preventing Diabetes

Many eating patterns can induce weight loss if calories are restricted compared to usual intake. In 2019, the American Diabetes Association (ADA) published a consensus report on Nutrition Therapy for Adults with Diabetes and or Prediabetes and reviewed 8 eating patterns including Mediterranean, vegetarian or vegan, low fat, very low fat, low carb, very low carb, DASH (Dietary Approaches to Stopping Hypertension), and Paleolithic/Paleo. ²⁸¹ All eating patterns produced weight loss except for Mediterranean and Paleo. Despite the Mediterranean eating pattern having less impact on weight, this eating pattern is associated with decreased risk of diabetes. ²⁸² Of these 8 eating patterns, 4 were associated with decreasing risk for T2D including Mediterranean, vegetarian or vegan, DASH, and low fat. The ACLM analyzed nutrition recommendations for preventing and treating T2D in 12 CPGs and found consistent and closely aligned messaging, emphasizing vegetables (92%), legumes/pulses (75%), whole grains (67%), and fruit (67%). In contrast, the top foods to exclude or minimize were processed meat (42%), red meat & pork (25%), refined grains (25%), and fatty meat (8%). ²⁸³

These recommendations can be operationalized with more plant-predominant eating patterns. For example, Mediterranean, vegetarian or vegan, low fat, and the DASH eating patterns all include predominantly plant food sources such as fruits, vegetables, beans/legumes, nuts/seeds, and whole grains while limiting red meat, processed foods, and added sugars. Moreover, these plant-predominant eating patterns are high in fiber which reduces the risk of T2D by between 15% and 20%, with a 9% risk reduction for every 10 grams per day increase fiber intake. ²⁸⁴ Dietary recommendations across CPGs for diabetes show strong consensus to include/increase intake of vegetables, legumes/pulses, fruit, whole grains, fish/seafood, and nuts and seeds. The most often discouraged food groups, as indicated by dietary guidelines, are processed meat, red meat, and refined grains. ²⁸³

Emphasizing Whole-Foods and Avoiding Ultra-Processed Foods

Also common among these eating patterns is that they emphasize whole-foods and avoid ultra-processed foods. Whole-foods—such as fruits, vegetables, legumes and whole grains—are rich in dietary fiber, which is often absent or minimally present in ultra-processed foods. Increased dietary fiber intake by adults with T2D can reduce HbA1c and fasting glucose, ²⁸⁵ may improve renal outcomes, ²⁸⁶ and has beneficial effects on the gut microbiome that include an increase in beneficial bacteria (Bifidobacterium), glycated hemoglobin, and short-chain fatty acids. ²⁸⁷ An active approach to increasing whole-foods and dietary fiber would have the added benefit of reducing the amount of ultra-processed foods consumed.

Eating plans high in ultra-processed foods cause excess calorie intake and weight gain. ²⁸⁸ Since ultra-processed foods can impair weight loss, whole or minimally processed eating patterns are preferred for preventing T2D. Conversely, consuming a higher proportion of ultra-processed foods in the eating plan is associated with a higher risk of T2D. ²⁸⁹ Ultra-processed foods are defined using the NOVA criteria (Figure 18). ²⁹⁰

Figure 18.

The NOVA criteria: classification of food into 4 groups by amount of processed ingredients, with examples of foods and processing methods, showing increased levels of processing moving from left to right. An optimal eating plan emphasizes foods in group 1 and minimizes, or completely avoids, foods in group 4. ²⁹⁰

Ultra-processed foods contain the least amount of fiber and have fewer vitamins and minerals compared to the whole intact, or minimally processed, original food source. Figure 19 shows how a food begins as whole and can become ultra-processed.

Figure 19.

Understanding ultra-processed foods. Handout for individuals explaining the health risks of ultra-processed foods, why whole-foods are better, and how to increase fiber in the eating plan.

Encouraging people at risk for T2D to add whole or minimally processed plant foods into their eating patterns is an approachable first step in prevention. Even though plants are a source of carbohydrates and can raise blood glucose, plants tend to have a positive impact on diabetes. For example, whole grains improve short-term glycemia and insulinemia compared to refined grains, which may improve HbA1c, a marker of long-term glucose management. ²⁹¹ Increasing fruit intake reduces fasting blood glucose concentration, ²⁹² and consuming pulses (legumes) significantly reduces acute postprandial glucose concentration in normoglycemic adults and in those with T2D. ²⁹³ Further, a low-fat vegan eating plan is an effective alternative therapy to improve T2D biomarkers in those with, or at elevated risk of, developing diabetes. ²⁹⁴ The effect of the eating pattern was similar to conventional energy restrictive eating plans, despite the absence of restrictions on energy intake or portion sizes.

Very Low Carbohydrate Eating Patterns

While very low carbohydrate eating plans can be helpful for weight loss over the short term, ²⁹⁵ and may be a dietary pattern that some individuals prefer, there is a risk of lower nutrient intakes and increased LDL cholesterol when avoiding legumes, fruits, and whole intact grains. ²⁹⁶ Given these risks and their potential impact on cardiovascular health, the duration of this eating pattern should be discouraged. If an individual at risk for diabetes wishes to pursue this eating pattern, despite the downsides, the duration should be limited followed by a gradual re-introduction of nutrient dense carbohydrates (fruits, vegetables, legumes, and whole intact grains), while emphasizing physical activity and overall calorie intake for sustainable weight loss.

Plant-based, very low carbohydrate nutrition plans can also be discussed and may have more favorable impact on cardiovascular risk factors and lipid profiles.^297,298 If a person at risk for diabetes chooses a very low carbohydrate eating pattern or a low-fat vegan eating pattern, these patterns should be well designed to meet nutrient needs (as noted in Statement 8.)

Implementing a Nutrition Plan

RDNs are preferred clinicians for delivering nutrition counseling as they are well versed in assessing nutritional intake, and they are trained to consider the social and cultural environments that can impact a person’s eating patterns. RDNs provide medical nutrition therapy (MNT), which in adults with T2D can improve glycemic outcomes, anthropometrics, blood pressure, and most lipid levels. ²⁹⁹ While individualizing nutrition advice is ideal, there are some practical tips that can be used when teaching people at risk for diabetes how to transition towards a whole, minimally processed eating pattern (Figure 20). Another helpful resource in supporting individuals is ACLM’s handout on whole-food, plant-based eating on a budget, ³⁰⁰ which was originally created to help Women Infant and Children (WIC) participants follow a budget-friendly whole-food plant-based eating plan but can be used with various populations.

Figure 20.

Moving toward a plant-predominant eating pattern: handout for individuals to promote a better understanding of a plant-predominant, whole-food eating pattern with practical tips for implementation.^282,301

A variety of barriers can present challenges with dietary behavior change and adherence. Table 10 presents common barriers and potential solutions that may be useful to explore when counseling individuals.

Table 10.

Common Barriers and Potential Solutions to Address Dietary Change and Adherence Among People With T2D Who Are Open to Considering Change.

Barrier	Strategies
• Person lacks knowledge or skills in cooking or preparing plant-based foods	• Provide handouts referenced in this guideline; refer to cooking classes or community events when available; suggest recipe and cooking social media to follow.
• Person expresses concern about cost of healthy eating plan	• Focus on simple plant-based foods such as beans, whole grains, and frozen vegetables, as opposed to mock meats or processed replacements; refer to “WFPB Eating on a Budget.”
• Friends and family may be unsupportive or may eat very differently in the home	• Discuss the possibility of frank conversations with friends and family, especially those who live with the individual. Help the person craft a strategy to ask for help from these people and potentially make certain compromises related to keeping certain foods out of the home for the sake of their health. Help the person set SMART goals that will support them in these conversations and planning.
• Person faces food access issues	• Focus on strategies that are possible for the individual given their circumstances, encouraging and celebrating all their success at every level. Explore food delivery options when locally available. Focus on frozen vegetables and fruits rather than fresh. Counsel them on making the best choices possible when shopping, without judging or worrying about what is not possible.

People at risk for diabetes should be referred to a RDN ²⁹⁹ for medical nutrition therapy, and/or health coaches or a diabetes care and education specialist, when team members are available who are experienced at lifestyle for T2D prevention. People at risk for diabetes should also be referred to any digitally or locally available programs, whether medical or non-medical, that may help them maintain their best dietary habits over the long-term. While the time required for effective counseling and behavioral medicine poses a challenge with many current reimbursement models, a potential benefit of adoption of the recommendations in this guideline would be to help justify the benefits of that contact time, which could lead to potential changes in reimbursement by health systems and insurers.

KAS 8: Prescribing a Nutrition Plan for Treatment

The clinician, HCP, or their designee, should clarify with the person with T2D if their goal is to achieve T2D remission or T2D improvement and should prescribe a nutrition plan using SMART goals that is consistent with the person’s desired outcome(s), cultural background, and is framed in food-based guidance promoting appropriate energy intake, nutrient needs, and the benefits of a whole-food, plant-predominant eating plan. Strong recommendation based on RCTs and systematic reviews with a preponderance of benefit over harm.

Action Statement Profile

• • Quality improvement opportunity: To increase early nutritional interventions for achieving remission in people with T2D or improvement objectives using SMART goals (National Quality Strategy Domain: Person- and Family-Centered Care; Effective Communication and Care Coordination; Prevention and Treatment of Leading Causes of Morbidity and Mortality)

• • Aggregate evidence quality: Grade A, based on 31 systematic reviews or meta-analyses and on 11 RCTs

• • Level of confidence in evidence: High

• • Benefits: Determine the type and intensity of nutritional intervention; avoid implementing a plan that is unlikely to be accepted by, or adhered to, by the individual; educate the individual about the potential to achieve remission in many adults with T2D; promote individual autonomy and agency; enhance collaborative relationship with the individual; promote adherence to recommendations; educate, advise, and inform the individual; offer specific and actionable advice that is tailored to the person’s needs and preferences; raise awareness regarding the 3 key areas of focus: energy/calories, nutrients, and a low-fat plant-predominant eating pattern; focus on process, not outcomes, to improve adherence

• • Risk, harm, cost: No risk for asking individuals to clarify their T2D remission or improvement goals; however, the individual may be unreceptive to advice, or overwhelmed, if not managed in a sensitive, easy to understand, professional manner. Costs include food cost, risk of disordered eating, stigma, lack of access to appropriate and culturally acceptable food (e.g., problems in food deserts, food swamps, and with food apartheid), time counseling individuals

• • Benefit-harm assessment: Preponderance of benefit over harm

• • Value judgments: Although the GDG recognizes that remission is the optimal goal for adults with T2D if physiologically feasible, not all individuals may be willing to commit to this degree of intervention, and should this occur, a goal of improvement is reasonable. It is the perception of GDG that remission and eating plan as a frontline approach to treatment are not always communicated as options to people with T2D

• • Intentional vagueness: None

• • Role of patient (individual) preferences: Large role for shared decision-making, both in deciding upon the goal (remission vs improvement) and in devising and implementing a culturally relevant acceptable action plan

• • Exceptions: None

• • Differences of opinion: None

• • Implementation considerations: Decision aid for remission vs improvement; preference for referral to registered dietitians and other team members who can educate individuals one-on-one, especially those with low literacy

Supporting Text

The purpose of this statement is to identify the need to elicit individual goals ¹⁷⁷ and preferences regarding their potential targeted health outcomes with respect to diabetes progression, improvement, or remission of T2D, and to provide context for clinicians to design a nutrition recommendation referral/plan, based on current best research evidence, with individuals that will be effective in achieving those goals.

Improvements in dietary quality and adherence to an eating plan designed for diabetes remission would confer benefits such as reduced risk of T2D, ³⁰² better glycemic management, weight optimization, lowered cardiovascular risk, and potentially a reduced need for pharmacologic therapy.^303-309 ACLM defines remission as non-diabetic blood glucose (HbA1c <6.5%) for at least 3 months without glucose-lowering medication. ¹³ The experience of living free of the side effects of glucose-lowering medications when this occurs is likely to improve quality of life for many people. ³¹⁰

While virtually all people with diagnosed diabetes or prediabetes are offered pharmaceutical solutions to elevated blood glucose, a discussion of eating pattern as first-line therapy is perceived as uncommon by our GDG. Clinicians and HCPs should educate the individual about the possibility of remission with appropriate dietary changes, refer individuals to RDNs, diabetes care and education specialists, and health coaches ³¹¹ when possible, and should, through shared decision-making, ¹⁷⁹ synthesize the person’s stated goals ¹⁷⁷ with their previously assessed readiness to change to maximize treatment potential.

Remission as an Optimal T2D Outcome

Remission may be an optimal outcome for many people with T2D but others may not be interested in remission or the effort to achieve it. If so, the clinician should follow the person’s lead and offer support towards improving glucose management and associated metabolic biomarkers such as lipid profile within acceptable targeted levels first with lifestyle behaviors, particularly eating plan and physical activity. Remission has been achieved by many adults using energy-restricted diets ³¹² ; low-fat, whole-food, plant-based interventions ³⁰⁹ ; and a carbohydrate restriction eating pattern. ³¹³ To pursue remission, a dietary intervention of appropriate dosing intensity ⁴⁴ is needed, requiring substantive and comprehensive changes in meal patterns and food choices beyond simply making modest additions or subtractions.

Optimal dosing for a goal of remission might consist of a substantive overhaul of the eating plan to replace meats, refined foods, sweet and salty snacks, and sweetened foods with vegetables, fruits, whole grains, and legumes. In contrast, a sub optimally dosed dietary change might be to reduce sugar-sweetened beverages, take a fiber supplement, or add a salad once per day while still otherwise consuming a standard American eating plan high in meat and processed food. Early intervention is beneficial and preferable, as opposed to a watching and waiting approach after elevated HbA1c or a recent diagnosis of T2D.

Regardless of the intensity of eating pattern change, clinicians should ensure that individuals on hypoglycemic agents have access to treatment for hypoglycemia when implementing dietary and lifestyle changes. The risk of hypoglycemia can be reduced using continuous glucose monitors and structured diabetes education programs (Tables 11 and 12). ³¹⁴

Table 11.

Comparison of Dietary Approaches for Improved Glucose Management vs Diabetes Remission.

	Goal of Improved Glucose Management With Possible Reduction of Medications	Goal of Diabetes Remission
Food groups	Emphasize high-fiber, plant foods including whole grains,291,315 fruit, 292 and legumes.293,316	Eat a low-fat, high-fiber, whole-food, plant-predominant eating plan emphasizing leafy greens, other vegetables including starchy vegetables, fruit, 292 whole grain,291,315 and legumes.293,316 Aim for limited consumption of more energy-dense plant foods or foods higher in fat, such as nuts, seeds, avocado.
Processed/refined foods and foods with added fats/oils	Reduce highly processed/refined foods such as sugar-sweetened beverages, refined flour products, fried foods, and salty snacks.	Avoid all highly processed/refined foods such as sugar-sweetened beverages, refined flour products, fried foods, and salty snacks. Avoid eating or using added fats/oils.
Calorie restriction, meal replacements, or intermittent fasting	Improvements in glucose management are possible without necessarily engaging in energy restriction or intermittent fasting.	For individuals open to a more intensive phase-in period, begin the dietary change with an initial program of intermittent fasting 317 or calorie restriction, 312 aiming for sufficient reduction (>500 kcal deficit or <1000 kcal/day)312,318-320 to produce >10% weight loss, 312 with duration to be determined based on the individual’s ability to tolerate or not experience any negative effects. Meal replacements may be used temporarily to achieve substantive energy reduction. Individuals should be informed of any potential negative signs and symptoms, including those associated with hypoglycemia from diabetes medications (e.g., insulin and sulfonylureas).
Implementation strategies	Individuals must demonstrate some degree of motivation and readiness to change; having support family members or friends in the household is very helpful, while having non-supportive social networks can derail efforts. 321	Individuals must demonstrate motivation and readiness to make substantive eating plan changes; having support family members or friends in the household is very helpful, while having non-supportive social networks can derail efforts. 321 Additionally, for the great level of commitment required for an intensive eating plan change or calorie restriction, individuals must exhibit strong motivation and self-efficacy with making different nutrition choices. Clinicians and HCPs should discuss anticipated challenges from the food environment, social networks, or habits and construct tailored strategies 322 with the individual to counter them. 179

Table 12.

Conversation Prompts for Shared Decision-Making for People With Diabetes Based on Motivational Interviewing Principles.^324,325

Clinician: Is diabetes remission something you think you are interested in, which means managing your diabetes without a need for medications to lower your blood sugar levels?
Person: Definitely yes	• Clinician: Alright, let’s talk about remission as the goal. We never know what will happen for any individual person, but I think it could be possible. And even if you don’t achieve full remission, you can make some incredible improvements. Would you like to talk about what you need to do…Transitions into the fundamentals of intensive, therapeutic eating plan change, with SDM for developing SMART goals that can be used in nutrition prescriptions.
Person: Possibly; I’m not sure	• Clinician: I understand it may seem daunting. What are some of your thoughts and questions? Would you like to talk about what’s involved and how it could benefit you…Transitions into resharing of benefits of diabetes remission and what would be required in terms of eating plan changes.
Person: No, I don’t think so	• Clinician: Alright—let’s move forward with what is important to you. The idea of remission is something we can come back to in the future. For now, you have a great opportunity to really improve your blood sugar management—and maybe, even reduce some of your medications. Would you like to talk about what is possible for you now… Transitions into a scaled back discussion of non-intensive healthy eating plan changes for improved glucose management. SDM and SMART goals can still be implemented.

Clinicians or trained health care professionals should explain what diabetes remission is, its feasibility and relevance to the person (e.g., taking into consideration the duration of diabetes), and others’ experiences of remission, reduced medication, improved quality of life. Following this, clinicians should discuss with individuals this menu of dietary goals and accompanying lifestyle changes. Enabling SDM and individual buy-in will empower people to take control of their health and take ownership over lifestyle changes for lasting behavior maintenance.^179,323

An important point to emphasize with individuals considering lifestyle changes is that remission may be more feasible when the person has had diabetes for a shorter duration as compared to many years, but that it is unknown which individuals can achieve full remission. Individuals should have realistic expectations that no promises of remission are possible but be encouraged to make a commitment to try if they have an interest in that goal. Table 12 provides example conversation prompts that can be used to guide this SDM process. A motivational interviewing best practice is to avoid value judgments as responses to what individuals say, including positive judgments, so even if the person’s goal aligns with the clinician’s preference (such as remission), it is best to stay neutral in responses, that is, saying “Alright…” instead of “That’s great.”

Energy-Restricted Eating Plans

Energy-restricted eating plans, when used among individuals with diabetes, are successful in achieving remission, with greater accompanying weight loss associated with increasing rates of remission.^312,326 In the DiRECT Trial, 2-year, open-label, cluster-RCT conducted among 298 participants at 49 primary care practices in the UK, the likelihood of remission, and the successful maintenance of remission, was directly correlated with the amount of body weight lost and maintained. ³⁰⁷ Other predictors of remission included prescribed fewer glucose-lowering medications and having better quality of life/less depression or anxiety. ³²⁷ While individuals in the DiRECT trial started with a BMI of 27-45 kg/m², rates of remission varied as follows: 86% remission rate among those who lost 15 kg or more, 57% with 10-15 kg weight lost, 34% with 5-10 kg weight lost, and only 7% remission rate among those who achieved a 0-5 kg weight loss. ³²⁸

When coupled with bariatric surgery, individuals who achieved remission with a lifestyle intervention lost more than 7% of their body weight in 12 weeks. ³¹⁹ Based on systematic review data on energy restriction and remission for individuals with obesity or overweight, a target weight loss of at least 10% of body weight should be the goal for remission of T2D. ³¹² Thus, eating plan changes that have been demonstrated to produce substantive weight loss are more likely to be effective for goals of remission.

Understanding the biological mechanisms involved in insulin resistance and diabetes is important for clinicians and HCPs when motivating individuals to make helpful eating plan choices. Insulin resistance develops when ectopic fat accumulates in the liver and pancreas; ³²⁹ at the same time, β-cell function is compromised. ³²⁹ Decreasing stored fat via weight loss can restore insulin sensitivity and β-cell function. ³²⁹ A post-hoc analysis of pancreatic morphology in the DiRECT Trial confirms that for individuals with T2D, pancreatic irregularities in shape and reduced volume had normalized among those who achieved normal blood glucose by 24 months, with a reduction in pancreatic fat of 1.02%. ³⁰³ Making substantive and comprehensive eating plan changes will increase the chances of remission by enabling greater weight loss for most individuals, leading to greater decreases in pancreatic and hepatic fat.

This improvement in ectopic fat and associated insulin sensitivity in DiRECT was produced with liquid meal replacements providing approximately 830 kcal/day for the first 3 to 5 months of the intervention followed by stepped food re-introduction for 2 to 8 weeks and then education support for long-term weight maintenance. ³²⁸ This approach could work for some but may be too challenging for others to adhere to. There are other eating patterns known to produce substantive weight loss, and some of these may be easier for individuals to adopt and maintain. Table 13 presents a menu of recommended eating patterns for improvement in glucose management, with considerations for remission and cardiovascular health.

Table 13.

Eating Patterns Observed to Be Effective for Improving Glucose Management and Weight Loss.

Eating Pattern Tested or Observed	Documented Remission Outcomes or Rapid Reductions in Glucose-Lowering Medication Needs	Benefits for Cardiovascular Health 330	Special Considerations	Demonstrated Feasibility for Long-Term Adherence or Duration
DASH308,331	—	✔	—	✔
Low-carbohydrate or keto-type eating plans313,332,333	✔	—	Long-term adherence to low-carbohydrate eating plans is incompatible with accepted guidance for risk reduction of cardiovascular disease305,330,334 May be high in saturated fat, and, depending on food groups consumed such as in the context of Paleo diets, may additionally be low in calcium and potassium without supplementation 335	—
Low-fat, whole-food, plant-based306,309	✔	✔	Naturally very high in fiber 318 May be low in vitamins D and B12 without supplementation 318	✔
Low-glycemic index eating plans 336	—	✔	—	✔
Mediterranean337,338	—	✔	—	✔
MyPlate recommendations 304	—	✔	—	✔
Plant-predominant/vegetarian297,302,337	—	✔	—	✔
Vegan/low-fat vegan294,302,339	—	✔	Naturally very high in fiber 318 May be low in vitamins D and B12 without supplementation 318	✔
Very low-calorie eating plans312,319,320 (>500 kcal deficit or <1000 kcal/day)	✔	✔	Not feasible as a long-term lifestyle Individuals should be screened for a history of eating disorders to ensure that calorie-restricted eating plans are not being recommended to this population	—
Intermittent fasting317,340-342	—	—	Research on long-term maintenance of this behavior is limited	—

Low-Carbohydrate Eating Patterns

Low-carbohydrate, ketogenic (keto) eating plans, ³¹³ and very-low carbohydrate eating plans are popular and may be effective for short-term (up to 2 years) remission or improved glucose management.^332,333 Improvements in blood glucose from low-carbohydrate eating plans may be primarily driven by weight loss, ³⁴³ while both body weight and blood lipids may exhibit a U-shaped relationship with carbohydrate restriction at 6 and 12 months. ³⁴⁴ Additionally, benefits for glucose management are not seen at 24 months. ²⁹⁵ Low-carbohydrate eating plans may be difficult to adhere to, ³⁴⁵ and lifetime adherence to low-carbohydrate eating plans has not been studied.

The high saturated fat and animal protein content of low-carbohydrate, or very low-carbohydrate (keto), high fat eating plans may impair cardiovascular health over the long-term,^305,334 and should not be promoted to people with diabetes. The American Heart Association has identified most elements of very low-carbohydrate eating plans as being incompatible with recommendations for heart health. ³³⁰ Some improvements in eating plan quality, however, improve upon the standard American diet, such as the avoiding sugar-sweetened beverages, refined flour products, and ultra-processed foods, and including more vegetables. Individuals interested in a very low-carbohydrate eating plan should be cautioned about the risks and difficulties in adherence, counseled to focus primarily on whole-foods, and instead encouraged to pursue a whole-food, plant-predominant eating plan. ³⁴⁶

Cautions Regarding Eating Patterns

Specific eating patterns may carry certain concerns for nutrient adequacy, and the nutrients of public health concern, which are under-consumed or over-consumed by a majority of the population and also associated with negative health consequences, ³⁴⁷ are important to discuss when counseling individuals with diabetes. These are calcium, fiber, potassium, vitamin D, sodium, and saturated fat. Table 13 presents cautions and special considerations for specific eating patterns. When an individual follows a specific eating plan, supplementation of the under-consumed nutrients should be considered, based on the eating pattern being followed, and bloodwork taken to accurately assess specific nutrient status. Importantly, individuals should be screened for a history of eating disorders to ensure that calorie-restricted eating plans are not being recommended to this population.

Some important cautions should also be noted regarding intensive eating plan changes and its impact on HbA1c, which can cause rapid drops in blood sugar and hypoglycemia when medications are not adjusted and reduced accordingly. Individuals should check blood sugar frequently when embarking on intensive eating plan changes, and if they were prescribed long-acting insulin or sulfonylureas, a more gradual beginning of the eating plan changes is preferable to reduce the likelihood of hypoglycemia. Ideally, intensive eating plan changes should not be fully adopted until long-acting glucose-lowering medications have fully exited the person’s body, or after the clinician has been able to reduce or adjust diabetes medications that could cause hypoglycemia. See Key Action Statement 14 for more information on medication management.

Counseling and Behavior Change

Individuals should, ideally, be helped to develop a set of goals that will lead to long-term, sustainable eating plan changes. While not all individuals will have the same readiness to adopt their ultimate, healthiest behaviors immediately, many individuals may be willing to set bigger goals as they make progress sticking with smaller goals. Clinicians should continue to explore individuals’ willingness to set goals for remission or blood glucose improvement as they progress and should not assume that a given individual is uninterested or incapable of making eating plan changes.

For individuals who do not demonstrate readiness to target remission as their outcome, and/or who may feel reluctant to consider giving up refined processed food, all animal foods, or foods they value or place importance on for personal or cultural reasons, other conversations about choices will be important, and appropriately culturally tailored interventions should be used for optimal outcomes in glucose management. ³²² A spectrum of recommended eating patterns should be presented to such individuals, and they should be counseled using SMART goals to scale back their consumption of animal foods from multiple times per day to once or less per day if possible. SMART goals should also be used to ensure that health-promoting foods are consumed daily, such as legumes, nuts, seeds, and whole grains. The handout for individuals “Healthy Foods are Everywhere” (Figure 21) provides examples of culturally diverse ingredients and dishes from a variety of cuisines and may be helpful to share with individuals who want ideas for plant-based foods to prepare.

Figure 21.

Healthy foods are everywhere. A handout for individuals that provides culturally diverse, plant-based examples of food ingredients and international cuisines.

Culturally acceptable animal food choices emphasizing fish, low-fat dairy, poultry, and minimizing meats higher in fat and saturated fat should be discussed, while the spectrum of eating patterns, including completely plant-based patterns, can still be shared. ³⁴⁸ The importance of fiber, which has been shown to help regulate blood glucose, ³⁴⁹ should be highlighted in all cases, particularly when consumed as part of a whole-food, plant-predominant eating plan. Fiber intake can be encouraged with SMART goals for eating vegetables, legumes, and whole grains.

Referrals to Interdisciplinary Team Members

Individuals should be referred to a RDN for medical nutrition therapy, with or without a health coach or diabetes care and education specialist, when team members are available who are experienced at lifestyle for diabetes remission or improved control. Individuals should also be referred to any locally available programs, whether medical or non-medical, that may help them maintain their best dietary habits over the long term.

KAS 9: Peer/Familial Support and Social Connections

The clinician or HCP should counsel adults with prediabetes, T2D, or a history of GDM regarding the importance of cultivating positive social connections provided by peers, family members, and/or other professionals trained in lifestyle change methods to achieve SMART goals and optimize glucose management. Strong recommendation based on RCTs, systematic reviews and metanalyses with a preponderance of benefit over harm.

Action Statement Profile

• • Quality improvement opportunity: To involve a person’s support system in achieving SMART goals and optimizing glucose management. (National Quality Strategy Domain: Person- and Family-Centered Care; Health and Well-Being of Communities)

• • Aggregate evidence quality: Grade A, based on 41 RCTs, 6 meta-analyses, 4 systematic reviews and 1 umbrella review demonstrating consistently that support interventions lead to improved outcomes in prediabetes and T2D management

• • Level of confidence in evidence: High

• • Benefits: Improve adherence to SMART goals, promote sustainable lifestyle behaviors, enhance positive social connections

• • Risk, harm, cost: Potential for a negative social connection

• • Benefit-harm assessment: Preponderance of benefit over harm

• • Value judgments: There is a perception among the GDG that the importance of peer support, family support, and positive social connections may be underappreciated as a factor that influences outcomes

• • Intentional vagueness: None

• • Role of patient (individual) preferences: Large

• • Exceptions: None

• • Differences of opinion: None

• • Implementation considerations: Handouts for individuals; loneliness assessments; availability of community programs or shared medical appointments

Supporting Text

The purpose of this statement is to advise clinicians or HCPs to promote social support interventions for people with prediabetes, T2D, or a history of GDM. Clinicians or HCPs should inform individuals that optimal management of prediabetes, T2D, or history of GDM includes building a strong network of social support outside the clinic.

Lack of social integration, support systems, and community engagement can lead to social isolation and loneliness that can negatively influence health by increasing health risks, decreasing function, and reducing quality-of-life. According to the Surgeon General’s Advisory on the Healing Effects of Social Connection and Community, loneliness has been linked to a higher likelihood of poor physical and mental health and poses both individual and societal risk. ³⁵⁰ For any suspicion of social isolation or loneliness, a simple and widely used 3-item survey (Table 14) has been validated to measure loneliness, ³⁵¹ with a much lower administrative burden than the 20 item UCLA scale ³⁵² upon which it is based.

Table 14.

3-Item Loneliness Assessment ³⁵¹

Questions About Feelings	Hardly Ever	Some of the Time	Often
1. How often do you feel that you lack companionship?	1	2	3
2. How often do you feel left out?	1	2	3
3. How often do you feel isolated from others?	1	2	3
TOTAL SCORE	6 or higher is “lonely”

Adapted from the 20 item UCLA loneliness scale. ³⁵²

Investigators have categorized individuals with combined scores of 3 to 5 as “not lonely” and those scoring 6 to 9 as “lonely.” ³⁵³ Alternatively, Maes et al ³⁵⁴ suggests the 20-item UCLA Loneliness scale as a common and more extensive survey to assess loneliness. For more general social health screening related to diabetes, the ADA Problem Areas in Diabetes (PAID) Scale ³⁵⁵ is a well validated 20-item tool that can assess for negative emotions related to diabetes and can also expose social isolation or other related problem areas.

Significantly, the same evidence mentioned above strongly validates the protective effects of positive social connections,^350,356-358 which can be a valuable adjunct to traditional healthcare approaches when cultivated through one-on-one or group formats with different support partners or leaders. Social support in diabetes management can help to minimize or eliminate harmful influences and promote healthy lifestyle behaviors. A large body of evidence, including 4 meta-analyses, 3 systematic reviews (SRs) and 1 umbrella review, details significant associations of positive social connections to improved primary and secondary health outcomes in diabetes care and provides solid rationale for this KAS.^27,359-364 Clinicians or HCPs should counsel people to develop and maintain a variety of social supports via peers, family members, HCPs, and other lifestyle change health experts to improve glucose management and to achieve SMART goals related to diabetes (See Statement 3).

Peer Support

Peer support in diabetes care is a structured intervention that utilizes a single peer or group of peers with diabetes to provide practical guidance and assistance to another PWD.^365,366 Peer support complements formal medical care and recognizes the value of connecting with other PWD on the common lived experience of navigating diabetes. The purpose of either one-on-one or group peer support is to provide education, discuss experiences, and offer encouragement to enhance self-management, coping, and well-being. One-on-one peer support typically involves a planned program of contacts between a PWD and trained peers with diabetes, usually organized by the HCP or care facility.

Peer group support interventions can also involve joint sessions between PWD and peer mentors along with HCPs, trained lifestyle change professionals, or other healthcare leadership combinations. Several meta-analyses and systematic reviews establish the effectiveness of peer-led interventions in improving glucose management, self-care behaviors, SMART goals, and overall quality of life for individuals with diabetes.^27,359-361 Peer support can be most effective in optimizing glucose management for people with HbA1c above 8.5%, especially at a moderate-to-high frequency of contact. ³⁵⁹ Peer support mentors with effective communication skills, HbA1c levels <8%, and an interest in coaching were found to be the most effective peer leaders. ³⁶¹

Various modes of contact, including face-to-face support, online forums, or other social media platform formats, have been shown to lead to improvements in self-management behaviors, biomarkers of disease, and psychosocial outcomes.^367-375 Clinicians or HCPs should inform individuals about the benefits of peer support, explain options, and assess a person’s interest in the support format of their choice: one-on-one, group, or a combination of both.

Peer programs revealed best outcomes in people with an HbA1c over 8.5% and 7.5% to 8.5%, and in those programs lasting between 3 and 6 months’ duration.^359-361,376 People with well-controlled diabetes should be identified for potential peer mentor roles by chart review for optimal glucose management with secondary reviews by HCPs or delegates for coaching interest and communication skills. ³⁷⁰ Refer to Table 15 for a comprehensive list of characteristics and best practices for designing and implementing peer interventions.

Table 15.

Implementation Strategies—Peer Support.

Peer Support
Tailor interventions to be sensitive and responsive to a person’s unique cultural and/or community needs
Characteristics
• Peer support mentors should share a current or past diagnosis of T2D, maintain an HbA1c <8%, possess effective communication skills, and personality traits of being open, conscientious, agreeable, and enthusiastic to teach/support. 361
• Advanced qualifications of peer support candidates include knowledge of T2D management, self-management fundamentals, and skills in facilitation including shared decision-making, motivational interviewing, and behavior-modification strategies. 361
Best practices/methods
• HCP-led process is suggested to find best peer support candidates. 370
• Best outcomes are seen in people with diabetes with poor glucose management (HbA1c ≥8.5% and 7.5-8.5%). 359
• Optimal program duration is >3 and <6 mos. 360
• Prioritize moderate or high frequency contact courses for PWD with poor control. 359 Avoid low frequency contact programs targeting the general population of PWD. 359
• Individual interventions may be more effective than group followed by individual interventions. 360
• Curriculum combined with focused reinforcement and home-visit interventions are suggested. 360
• Interventions delivered via telephone lead to long-term improvements in HbA1c. 376
• Social media, despite its limitations, can offer valuable, reliable information and educational resources on diabetes, facilitating self-paced learning opportunities. 375
• Culturally matched peer supporters, culturally relevant communication styles, respect for traditional healing practices, and culturally adapted education materials and peer supporter training in cultural competency.377,378
Other considerations
• Peer-led groups without HCP-led educational programs are less common but viable with non-HCP training.
• Support format and dose may determine efficacy of any individual intervention. 376

T2D, type 2 diabetes; HCP, health care professional; PWD, person with diabetes.

Family Support

Family support for an individual with prediabetes, diabetes, or a history of GDM refers to intentional care by family members including emotional support, assistance in daily self-management tasks, and involvement in lifestyle modifications. Various types of family support positively impact glucose management and overall well-being in individuals with diabetes and appear to be a key component to successful self-care management at home.^364,379 Several RCTs cite significant associations between family support interventions and positive health outcomes for people with diabetes^380-382 and prediabetes. ³⁸³

Although consensus has expanded on the positive role of family-level interventions in diabetes care, the number of existing RCTs on effective intervention design remains limited and further research is needed. ³⁷⁹ Clinicians or HCPs should ask individuals about their family situation and identify one or more family members, a trusted confidant, close companion, or friend to support them in their care. Once such individuals are identified, clinicians can provide strategies and resources for the person and family members, or confidants, to create a mutual plan to achieve person-, family- or partnership-centered behavior changes. Clinicians or HCPs should utilize the evidence-based components and strategies for planning family- or partnership-based support interventions for individuals included in Table 16.^364,379

Table 16.

Implementation Strategies—Family Support.

Family Support
Tailor interventions to be sensitive and responsive to a person’s unique cultural and/or community needs
Characteristics
• Include ≥ one or more family members or others with strong relationships to the person 379
• May involve HCP-led sessions for one-on-one, dyad, or small group counseling or for caregivers alone—all for defined periods 379
• Themes to address may include 364
○ Knowledge of diabetes and lifestyle behaviors
○ Family members’ roles in both promoting or detracting from an individual’s self-care
○ Non-familial psychosocial issues including stress management, anxiety, and coping
○ Family issues, like asking for support or avoiding negative stimuli
Best practices/methods
• Use both outcome measures for people with diabetes and psychosocial outcomes for families 379
• Use a “stepped care” approach 379
○ Basic training and knowledge
○ Intensify depending on individual and family outcomes—glucose management, SMART goals, quality of life, family dynamics, well-being, level of conflict
• Address/discuss issues including support strategies, 364 family action plans, and collaborative problem-solving 379
• Encourage support/participation in
○ Basic training and knowledge
○ Food shopping and meal prep
○ Health-related activities/visits
○ Shared needs for better lifestyle
○ Positive attitudes towards diabetes management
○ Open dialogue, listening and consoling
• Tailor family support to the cultural needs of the person by384-386
○ Assessing family dynamics and including key family members
○ Respecting and understanding health beliefs, including traditional practices
○ Incorporating religious and spiritual beliefs
○ Facilitating family involvement in care planning and creating safe spaces for discussions
Other considerations
• Family-based intervention designs vary widely. Studies of design effectiveness are limited; further research is needed. 379
• Family roles and quality of care can be impacted by the degree of PWD/family members’ diabetes literacy and education, individual’s emotional and physical care needs, care needs or limitations related to family finances, and cultural issues such as refraining from social contact due to perceived diabetes care constraints. 364

HCP, health care professional; PWD, person with diabetes; SMART, specific, measurable, achievable, relevant, and time-bound.

Professional Support

Professional support interventions are typically led by HCPs or other professionals trained in lifestyle change to offer focused support for individuals or groups with prediabetes, diabetes, or a history of GDM. Structured diabetes and lifestyle educational programs are delivered by trained professionals including clinicians, HCPs, lifestyle change instructors, health coaches, researchers, and community health workers (CHWs). Professionally led group interventions for individuals with prediabetes and diabetes correlate with improved care outcomes in 6 RCTs.^387-392 The outcomes include significant HbA1c reductions,^389,390 improved glucose management and SMART goal fulfillment,^{387,388,390-392} preventing non-diabetes hyperglycemia (NDH), and normalized glycemia in people with NDH. ³⁹³ As designs and outcomes vary, more research is needed to reveal best-practice methods for interventions led by various professionals with or without a peer support component.

CHWs are trained and culturally competent frontline caregivers, often from the communities they serve, who are trained by and collaborate with HCPs to deliver essential services, education, and advocacy while promoting consistent self-management. Specialized programs for diabetes care can be delivered by CHWs in health care facilities, wellness centers, and other community settings. In one meta-analysis of 17 RCTs that included interventions delivered by CHWs, Rawal and colleagues ²⁷ found CHWs, peer partners, or a combination of both showed small but statistically significant reductions in HbA1c. Four RCTs found that support provided by CHWs either one-on-one or in groups led to variable improvements in fasting blood sugar, HbA1c reductions and other SMART goal outcomes.^152,394-396

Clinicians or HCPs should investigate available lifestyle intervention program options in their healthcare facility, system, or local community, including the use of CHWs or other similar support options especially for individuals in low-income populations with limited access to care. The use of shared medical appointments (SMAs) to provide diabetes treatment offers a built-in level of social support, and the team-based approach has been found to be effective at improving clinical outcomes, satisfaction from individuals and clinicians with the healthcare experience, and with efficiency in treatment time. ³⁹⁷ SMAs have also been successfully used in the field of lifestyle medicine to enable reimbursement for the increased contact time with individuals needed to support successful behavior change. ³⁹⁸ Upon assessing the person’s needs and preferences, based on program schedule, size, and focus, clinicians or HCPs should recommend the most suitable intervention strategy to achieve the identified goal or endeavor to create one based on characteristics and best practices in Table 17.

Table 17.

Implementation Strategies—Professional/Multimodal Support.

Professional/Multimodal Support
Tailor interventions to be sensitive and responsive to a person’s unique cultural and/or community needs
Characteristics
• HCP-led or other non-HCP-led one-on-one support or group education with or without peer or family support are the most common and effective.
• Different settings and alliances can be used for effective delivery of interventions: homes, schools or facilities housing nonprofit or faith-based organizations; collaborations with employee wellness initiatives and health community partnerships.367,369,374,387-392,394-396,399-405
• Programs should be structured.389,391,400
○ Design programs to increase motivation for self-management and improve adherence.
○ Design to allow PWD to engage in discussions, education sessions, and activities.
• CHW home-visit and group interventions are commonly used in low-income, rural, and low access to care populations.27,152,406
Best practices/methods
• Topics covered may include diet strategies, exercise practices, medication management, blood glucose monitoring, lifestyle modifications, and emotional well-being.
• Leaders should aim to create a group dynamic conducive to open dialogue for sharing information, challenges, and successes; mutual emotional support; and developing coping strategies for the demands of diabetes management.
• Sessions are recommended to be held over weeks or months with regular frequency; generally ranging from 12 weeks to 12 months with regular follow-up for 6-18 months.367,369,374,387-392,394-396,399-405
• Interventions should be tailored to the person’s cultural needs through cultural sensitivity training, cultural mediators, culturally adapted communication, attention to cultural stigma/barriers, and linking with cultural community resources and health workers.407-409
Other considerations
• Whether in community, healthcare, or remote settings, meeting places should be private to allow individuals to address and share various aspects of their conditions.
• Common support frameworks include adjunctive peer support groups led by a trained peer leader, inclusion of family members or other caregivers, text messages or telephone calls with information and reminders, and additional information shared between sessions.

HCP, health care professional; CHW, community health worker.

Multimodal Support

Multimodal (MM) support strategies combine 2 or more different formats of support including peer, family, HCPs and/or other structured contacts with the various lifestyle change professionals. MM approaches also include varied methods of support (e.g., educational interventions, technological tools, psychosocial care, online or social media platforms) to achieve clinical goals. MM support has demonstrated clinical efficacy in improving glycemic outcomes and self-management behaviors according to several systematic reviews and meta-analyses of existing studies.^27,311,362 Ten RCTs combining 1749 patients from 6 countries receiving MM support showed benefits of reduced HbA1c levels and lower elevations in HbA1c in people with diabetes, with 9 of 10 RCTs also demonstrating variable, but substantial, improvements in cardiometabolic, anthropometric, psychosocial, and behavioral outcomes.^{399-402,404,406,410-413} The predominant form of MM support explored in the literature is peer support organized as an adjunct to professionally led programs which often included training for peer leaders and CHWs.^{27,367,369,374,387,388,390,399,403,406}

Any plan to implement a peer, family, professional or MM support should be based on results of pre-intervention assessment tools combined with an exploration of individual preference and the availability of local structured program options. Upon assessing individual needs, explaining options, and exploring preferences, clinicians or HCPs should recommend a single or combined set of support options targeted to the person’s goals. Although individual support needs vary widely, clinicians or HCPs should inform individuals of the benefits of combining different forms or methods of social support. Guidance should be provided to individuals according to the person’s degree of health literacy to ensure optimal understanding to make informed decisions and to effectively adhere to prescribed interventions (See Figure 22: “Relationships Matter” Handout). Support plans are best developed through the process of shared decision-making ⁴¹⁴ which has been shown to improve individual engagement, adherence, and self-management. ⁴¹⁵

Figure 22.

Relationships and better health. Handout for individuals showing how strong relationships can reinforce healthy lifestyle habits.

Benefits vs Costs

No studies directly identified potential risks or harms related to any type of social support interventions including associations to decreased glucose management or a worsening of secondary clinical outcomes for people with prediabetes or diabetes. There is credible concern regarding inadvertent dissemination of misinformation by well-intentioned peers, family, or other support providers, potentially harming the individual. However, when family and friends can be educated about lifestyle changes along with the PWD, the likelihood of receiving accurate and supportive messaging is increased.

Most of the studies included in this review did not assess cost-effectiveness or undertake cost-benefit analyses of the interventions. Two studies reported peer-led interventions were effective low-resource programs.^368,370 In a combined systematic review and meta-analysis, ²⁷ one study estimated the per-person cost of lifestyle interventions by nurses, dietitians, and community workers to be between US $131 to $384 depending on program length. This included the cost of educational sessions, support group sessions, and food provided. Although there are financial implications of employing CHWs, integrating CHWs into healthcare systems reduces cost through reduced hospitalizations, increased preventive care, and improved community health outcomes. ²⁷

In summary, positive social connections in people with prediabetes, T2D, or a history of GDM cultivated through peer, family, and professional support can lead to broad improvements in outcome measures and wellness. Conducting proactive assessments for loneliness or social isolation is crucial for baseline evaluations of individual well-being and to direct support interventions appropriately. Although specific social support methods and program designs vary, the evidence is well-established that social support interventions lead to improved self-management, adherence, and coping which is associated with improved glucose management, achievement of SMART goals, resilience, long-term health outcomes, and overall well-being. Clinicians’ knowledge of, and connection to, loneliness assessment tools and programmatic support options in their facilities and local communities, and their emphasis on, and implementation of, various and targeted support interventions will empower, motivate, and assist individuals and lead to wide-reaching improvements in diabetes care outcomes.

KAS 10: Identify Need for Psychological Interventions

In adults with prediabetes, T2D, or a history of GDM the clinician or HCP should identify or refer to someone who can identify serious mental illness such as severe mood/affective disorders, anxiety disorders, or psychotic disorders. For individuals experiencing stress or symptoms of depression or anxiety, prescribe mindfulness-based, cognitive behavioral therapy (CBT), or CBT-based interventions to improve diabetes clinical outcomes. Recommendation based on RCTs, systematic reviews, and meta-analyses with a preponderance of benefit over harm.

Action Statement Profile

• • Quality improvement opportunity: To identify individuals who may need further assessment for psychological interventions to improve diabetes-related outcomes (National Quality Strategy Domain: Patient Safety; Person- and Family-Centered Care; Effective Communication and Care Coordination; Prevention and Treatment of Leading Causes of Morbidity and Mortality)

• • Aggregate evidence quality: Grade B, based on 10 combined systematic reviews and meta-analyses, 2 systematic reviews, and 9 RCTs, with some limitations regarding methodology, study design, and sample size-indicating the relationship between diabetes and mental health and the effectiveness of mindfulness-based, CBT, and CBT-based interventions for managing T2D

• • Level of confidence in evidence: High

• • Benefits: Prioritize additional assessment and intervention for individuals who require further evaluation to improve mental health; avoid complications or sequelae of an underlying mental illness that may not have been previously recognized or diagnosed, better inform the management plan for diabetes mellitus by taking into account comorbid mental illness; raise awareness of stress management strategies for better disease-specific and overall health; identify diabetes distress burden and develop strategies to reduce them; provide information and strategies on how to improve mental health; reduce symptoms of anxiety and depression; and improve coping skills

• • Risk, harm, cost: Time counseling individuals, cost of additional assessment testing or referral, limited access to individuals who can perform the needed additional evaluations; frustration if unable to achieve goals

• • Benefit-harm assessment: Preponderance of benefit over harm

• • Value judgments: Perception by GDG that routine assessment of mental health is not always part of managing a person with T2D, but that this assessment is important for identifying conditions that may require special assessment, referral, or management

• • Intentional vagueness: We describe referral to “someone” who can identify serious mental illness because the key concept is to recognize when referral is needed, not necessarily to specify a specific entity or discipline. Although referral to a licensed mental health professional might be ideal, access is not universal and therefore some flexibility is needed in this regard.

• • Role of patient (individual) preferences: Limited, in terms of recognizing disorders, increased role in terms of acting on the advice; substantial role in terms of participating in psychological interventions

• • Exceptions: None

• • Differences of opinion: None

• • Implementation considerations: Table describing mental health illness, their relevance to diabetes, and their implications; FAQs regarding how to manage stress when a mental health illness is not present; education handouts for individuals; cultural sensitivity and adaptations

Supporting Text

The purpose of this statement is to ensure that clinicians and HCPs recognize and inform individuals about the relationship between mental health and T2D, given a higher risk of depression that is 2-3 times that of the general population, and risk of anxiety about 20% more than the general population. ⁴¹⁶ Additionally, they should identify potentially serious mental illness, ensuring it is not overlooked, and incorporate psychological interventions in the treatment plan.

There is a bi-directional relationship between diabetes and mental health conditions, particularly, depression, anxiety, and serious mental illness (e.g., severe mood/affective disorders, anxiety disorders, or psychotic disorders) due to a combination of factors including the burden of managing diabetes, lifestyle behaviors, antidepressant/antipsychotic medication use, brain structure and function, biological pathways, and environmental factors.^417-423 An example of this bi-directional relationship is shown in Figure 23, with regards to diabetes and depression.

Figure 23.

Diabetes and depression. Pathway showing how poor health behaviors that lead to obesity and adversely impact both diabetes and depression through a bi-directional relationship. ⁴¹⁷

Mental health conditions can interfere with optimal diabetes self-care and affect diabetes-related clinical outcomes. ⁴²⁴ Clinicians and HCPs should refer individuals to mental health professionals to appropriately assess and diagnose serious mental illness. They should also review the use of any psychotropic medications because many are not weight-neutral and could contribute to insulin resistance. In some cases, more weight- and metabolic-friendly medication alternatives may exist. With all individuals, clinicians can use the validated measures in Table 18 to assess symptoms of depression and anxiety, stress, and diabetes distress.

Table 18.

Validated Measures to Assess Psychosocial Factors Among People With T2D.

Psychosocial Factor	Descriptions/Symptoms	Validated Measure (# of Items)
Depression	• Depressed mood • Loss of interest or pleasure • Poor appetite or overeating • Trouble falling or staying asleep; sleeping too much • Feeling tired or having little energy • Feelings of worthlessness or inappropriate guilt • Trouble concentrating • Fatigue or loss of energy • Suicidality	Patient Health Questionnaire (PHQ-9) 425 (9 items), PHQ-4 426 Beck Depression Inventory (BDI-II) 427 (21 items) Hospital Anxiety and Depression Scale (HADS) 428 (14 items)
Anxiety	• Restlessness • Excessive worrying • Being easily fatigued • Difficulty concentrating • Irritability • Muscle tension • Sleep disturbance	Generalized Anxiety Disorder—7 (GAD-7) 149 (7 items) Beck Anxiety Inventory (BAI) 429 (21 items) PHQ-4 426 Hospital Anxiety and Depression Scale (HADS) 428 (14 items)
Stress	Emotional response to external triggers or changes that can be short- or long-term. Symptoms include: • Irritability • Anger • Fatigue • Muscle pain • Digestive troubles • Difficulty sleeping	Perceived Stress Scale (PSS) 430 (10 items)
Diabetes distress	An emotional state where people experience feelings such as stress, guilt, or denial that arise from living with diabetes and the burden of self-management.	Problem Areas in Diabetes (PAID)431,432 (20 items) Diabetes Distress Scale (DDS)433,434 (17 items)

To support people with T2D who are also experiencing stressors, symptoms of depression or anxiety, and/or diabetes distress, there are several effective intervention approaches to improve diabetes-related clinical outcomes. Mindfulness-based interventions, including the 8-session Mindfulness-Based Stress Reduction and meditative movements (e.g., Tai Chi, Yoga, and Qigong) have been associated with significant improvement in HbA1c^404,435-439 while also reducing symptoms of depression and anxiety as well as perceived stress and diabetes distress.^436,437,439 Furthermore, cognitive behavioral therapy (CBT) or CBT-based interventions are also effective in improving glycemic management.^440-448 Mindfulness-based and CBT-based interventions can be effectively delivered by non-mental health professionals/specialists,^436,447 which enhances the reach of these interventions in diverse communities.

The stress pillar overlaps with the other 5 lifestyle medicine pillars (Table 2) in that there are a few studies that suggest using physical activity^442,449 or nutrition ⁴⁵⁰ to manage stress and mental health may help improve both mental well-being and diabetes-related clinical outcomes. Figure 24 outlines a few helpful tips for managing stress that clinicians can share with individuals.

Figure 24.

Managing stress. Handout for individuals with suggestions on how to think about and manage stress for better health. Adapted from: (1) American Psychological Association tips for stress management ⁴⁵¹ ; (2) Lifestyle stress reduction: patient handout. ⁴⁵²

KAS 11: Tobacco, Alcohol, and Recreational Drugs

The clinician or HCP should assess adults with T2D for use of tobacco, alcohol, and other recreational drugs and should counsel them on how using these substances can adversely impact management of T2D. Strong recommendation based on RCTs, systematic reviews, and observational studies with a preponderance of benefit over harm.

Action Statement Profile

• • Quality improvement opportunity: To promote the individual’s awareness of the adverse impact of recreational drug use in the management of T2D. (National Quality Strategy Domain: Patient Safety, Person- and Family-Centered Care; Prevention and Treatment of Leading Causes of Morbidity and Mortality)

• • Aggregate evidence quality: Grade B, based on 3 RCTs, 3 systematic reviews, and 1 meta-analysis emphasizing the value of counseling on tobacco, nicotine and recreational drugs in adults with T2D

• • Level of confidence in evidence: High

• • Benefits: Raising awareness of an issue that might not have been fully appreciated by the individual; identifying opportunities to reduce harmful habits; triaging individuals for smoking cessation programs; identify alcohol use disorder

• • Risk, harm, cost: Perception of being judgmental, potential harm to clinician-person relationship

• • Benefit-harm assessment: Preponderance of benefit over harm

• • Value judgments: None

• • Intentional vagueness: The term “recreational drugs” is intended to include a variety of products

• • Role of patient (individual) preferences: Limited role in hearing or receiving advice; large role in the extent to which the advice is acted upon

• • Exceptions: None

• • Differences of opinion: None

• • Implementation considerations: Substance use assessment tools; education materials for individuals; smoking cessation; managing alcohol use disorder; referral sources

Supporting Text

The purpose of this statement is to encourage the clinician or HCP to assess tobacco, alcohol, and other recreational drug use at regular intervals using standardized screening tools. This assessment should be part of routine care for people with diabetes and prediabetes to identify substance use early and to tailor interventions accordingly. Individuals should be educated about the specific risks that tobacco, alcohol, and recreational drugs such as cannabis pose to their diabetes management and overall health. Potential adverse effects include the possibility of worsening glucose management, increasing the risk of diabetes-related complications, ⁴⁵³ and interfering with diabetes medications.

Tobacco Use

Research has emphasized the increased risk for cardiovascular disorders in smokers with diabetes compared to non-smokers with diabetes. ⁴⁵⁴ In one trial, subjects in the subgroup that completely abstained from smoking for 12 months had the second lowest increase in fasting blood glucose and had the greatest reduction in cardiac risk. ⁴⁵³

Clinicians or HCPs can diagnose, evaluate, and treat nicotine dependence as part of a routine office visit by using the NIDA Quick Screen to identify individuals using tobacco products within the past year. If the individual screens positive for tobacco use, it is important to determine how frequently they use tobacco products and the amount of tobacco used on a typical occasion. A standard way to record this information for a person who smokes cigarettes is how many cigarettes or how many packs of cigarettes smoked per day; and how many years has the person smoked cigarettes at this level. It is also beneficial to determine whether the person is interested in cutting down or stopping tobacco use.

Several instruments have been designed to measure the individual’s readiness to change. One well-known option is the University of Rhode Island Change Assessment (URICA) ⁴⁵⁵ ; and many clinicians and HCPs find the following two-question assessment to be adequate to determine the individual’s stage of change:

• 1. “Do you currently smoke?”

• 2. (If yes): “What are your thoughts and feelings about quitting smoking?”

Another assessment for evaluating readiness to change is the readiness ruler (Figure 25), described earlier in this guideline (see KAS 2). Tobacco use cessation may take some individuals several years, while others go from contemplation through preparation and into action within a single clinical encounter. ⁴⁵⁶ Cultivating a supportive, longitudinal relationship with a person undergoing the process of tobacco use cessation is an important component for success.

Figure 25.

Readiness ruler-evaluating readiness to change. The readiness ruler can rapidly assess how important, confident and ready an individual is to make a change. For additional information, please refer to Figure 4 in key action statement 2.

Recognizing that nicotine use can extend beyond smoking (e.g., vaping and gum chewing), another line of questioning to elicit change talk, respect the person’s autonomy, and avoid judgments that might impair conversation could be structured as follows, based on principles of motivational interviewing ¹⁶⁷ :

• 1. “Do you use nicotine?”

• 2. “Are you okay if we discuss it?”

• 3. “What do you like about nicotine use? Is there anything that you don’t like?”

• 4. “What might be different in your life if you did not use nicotine?”

• 5. “Would you like to explore this option?”

Alcohol Use

Alcohol use is common, with 84% of people aged 18 years or older reporting consuming alcohol at some point in their lives. ⁴⁵⁷ It is also a leading cause of preventable deaths in the United States. ⁴⁵⁸ Alcohol use disorder involves a problematic pattern of alcohol use that leads to significant distress or problems functioning. Therefore, health professionals should assess a person’s pattern of alcohol use and counsel them accordingly.

The NIDA Quick Screen ¹³² incorporates the U.S. Preventive Services Task Force (USPSTF) recommended NIAAA Single Alcohol Screening Question (SASQ) by asking “How many times in the past year have you had (4 for women, or 5 for men) or more drinks in a day?” Another efficient, and more comprehensive, alcohol use assessment option that is recommended by the USPSTF is the Alcohol Use Disorders Identification Test–Concise (AUDIT-C) ¹³¹ which consists of 3 questions related to drinking frequency and quantity. A score of 4 or more is considered positive for men; 3 or more is positive for women (Figure 26).

Figure 26.

Alcohol Use Disorders Identification Test - Concise (AUDIT-C) Test. Adapted Alcohol Use Disorders Identification Test - Concise (AUDIT-C) Test. ¹³¹

When a preliminary screening tool such as the NIDA Quick Screen or AUDIT-C yields a positive result, clinicians must conduct a comprehensive risk assessment. This subsequent evaluation should accurately measure the extent of alcohol consumption, assess its harmful impacts, and establish the appropriate subsequent interventions in the person’s care. Research endorses the strategy of initiating the use of brief screening tools that possess high sensitivity but lower specificity, succeeded by more detailed assessments that offer increased specificity, for example, the AUDIT. ⁴⁵⁹

Level of Alcohol Consumption and T2D

Moderate wine consumption, defined primarily as red wine and between 4 and 10 ounces per day, can lower diastolic blood pressure in adults with T2D, but does not impact glucose parameters and other cardiovascular effects. ⁴⁶⁰ Conversely, moderate alcohol consumption may reduce fasting insulin and improve insulin sensitivity among women without diabetes, but not among men, but the relevance of these findings to people with diabetes is unclear. ⁴⁶¹ In the same study, however, moderate alcohol consumption may have reduced HbA1c levels among both men and women who do not have diabetes. ⁴⁶¹

Another study, Gepner 2015, ⁴⁶² randomized people with diabetes to 5 ounces of mineral water, red wine, or white wine with dinner for 2 years. All groups were advised to follow a Mediterranean eating pattern without caloric restriction during the intervention period. This study suggested that initiating moderate wine intake, especially red wine, among persons with well-managed diabetes as part of a healthy eating plan may modestly decrease cardiometabolic risk. In the same study it was found that the genetic interactions suggest that ethanol plays an important role in glucose metabolism and red wine’s effects also involve nonalcoholic constituents. ⁴⁶² Another small, randomized trial did not demonstrate improvement of inflammatory markers with red wine consumption in people with diabetes. ⁴⁶³

Moderate alcohol consumption of less than 5 ounces of red wine (approximately 20 grams of alcohol) might have some protective cardiovascular effects in the general population, ⁴⁶² but its impact on blood glucose levels is not definitive. ⁴⁶⁰ Studies suggest that moderate alcohol intake can be associated with reduced risk of T2D among those at high cardiovascular risk, ⁴⁶⁴ but these findings must be balanced against potential adverse effects; including hypoglycemia, weight gain and increased risk of cancer ⁴⁶⁵ and cardiac arrhythmia. ⁴⁶⁶ A trial randomizing people with T2D to drink either 5 ounces of red wine, white wine, or water along with following a Mediterranean eating pattern for 2 years suggests that initiating moderate wine intake, especially red wine, among persons with well-managed diabetes did not worsen carotid atherosclerosis or cardiac risk factions such as systolic BP and Apo(B)/Apo(A) ratios, and modestly decreased carotid plaque volume in individuals in the highest tertile of plaque burden. ⁴⁶⁷

The U.S. Department of Agriculture and U.S. Department of Health and Human Services. Dietary Guidelines for Americans, 2020-2025 provides a pragmatic approach, recommending not more than one drink per day for women and 2 for men. ⁴⁶⁸ However, the World Health Organization advises that there is no safe level of alcohol use in regard to cancer risk. ⁴⁶⁹

Marijuana Use and Risk of Prediabetes and Diabetes

According to a 2021 CDC report, ⁴⁷⁰ marijuana was the most frequently used illicit drug in America, with an estimated 48.2 million adults using it at least once. This number is expected to rise over time with states permitting marijuana use for medicinal and recreational purposes. ⁴⁷¹ In the Coronary Risk Development in Young Adults (CARDIA) study, ⁴⁷² marijuana use, by status of lifetime frequency, was not associated with the incidence or prevalence of diabetes after adjustment of potential confounding factors. However, marijuana was associated with the development and prevalence of prediabetes after adjustment, ⁴⁷³ likely related to the practice of unhealthy lifestyle behaviors and consumption of a high calorie eating plan. In a randomized, double-blind, placebo-controlled study ⁴⁷⁴ involving people with T2D, the impact of cannabidiol and tetrahydrocannabivarin (THCV) on glycemic and lipid levels has been evaluated. This study showed THCV improved glucose management, and cannabidiol failed to show any detectable metabolic effects. ⁴⁷⁴

Alternatively, there are reports showing that abusing recreational drugs increases the risk of metabolic syndrome and diabetes, resulting partly from increased cell damage due to the effects of opioids on glucose homeostasis. The recreational substances include cannabis, hallucinogens, opioids, and stimulants. A systematic review and meta-analysis found that substance abuse does not have significant effects on postprandial blood glucose and glycated hemoglobin in people with diabetes. ⁴⁷⁵

When choosing screening instruments for substance use in primary care settings, several considerations come into play. In environments where time is limited, brief screening tools, such as the NIDA Quick Screen ¹³² (Figure 27)—which consists of 4 questions regarding the use of alcohol, tobacco, non-medical prescription drugs, and illegal drugs over the past year—are often favored. However, more comprehensive tools, like the 8-item ASSIST (Alcohol, Smoking and Substance Involvement Screening Test), are valuable for more in-depth assessment of risks related to unhealthy substance use or accompanying conditions. These extended tools can provide critical insights that necessitate immediate action in people initially testing positive for drug use. ⁴⁷⁶

Figure 27.

NIDA quick screen question for substance use and directions for coding the responses.

In summary, consuming alcohol, using tobacco, and using recreational drugs, including marijuana, has detrimental effects on individuals diagnosed with T2D or prediabetes. These substances can exacerbate metabolic dysfunction by impairing blood sugar control and increasing the risk of cardiovascular diseases. Moreover, alcohol and certain recreational drugs can interfere with the efficacy of diabetes medications, leading to unpredictable glycemic responses. Therefore, it is imperative for HCPs to counsel people with T2D or prediabetes on the importance of abstaining from or minimizing the use of these substances as part of their overall disease management and lifestyle modification strategies.

KAS 12: Achieving Person-Driven, Sustained Positive Behavior Change

For adults with prediabetes, T2D, or a history of GDM, the clinician, HCP, or their designee, should help individuals achieve sustained, person-centered, positive behavior change using evidence-based approaches including, but not limited to, coaching, motivational interviewing, and cognitive behavioral therapy. Strong recommendation based on RCTs, systematic reviews, and observational studies with a preponderance of benefit over harm.

Action Statement Profile

• • Quality improvement opportunity: To improve the person’s probability of sustained, positive behavior by using evidence-based approaches. (National Quality Strategy Domain: Person- and Family-Centered Care; Effective Communication and Care Coordination; Prevention and Treatment of Leading Causes of Morbidity and Mortality)

• • Aggregate evidence quality: Grade B, based on 6 systematic reviews, 8 RCTs, and 2 quasi-experimental studies for health coaching-centered interventions; an umbrella systematic review of 41 systematic reviews for self-management interventions; 1 systematic review about digital technology integration; and 32 systematic reviews with combined 27 RCTs for CBT and 10 additional RCTs from cross referencing

• • Level of confidence in evidence: Low to medium

• • Benefits: Improve chances of successful behavior change; person engagement and empowerment; long-term sustainability of changes; person’s ability to brainstorm and solve problems; and enhance the therapeutic relationship

• • Risk, harm, cost: Time counseling individuals, cost of coaching, reimbursement hurdles, potential for ineffective approaches from insufficiently trained clinicians

• • Benefit-harm assessment: Preponderance of benefit over harm

• • Value judgments: Assumption by the GDG that without specific attention to sustained behavior change, any lifestyle changes made by individuals are more likely to be of short-term duration

• • Intentional vagueness: None

• • Role of patient (individual) preferences: Large

• • Exceptions: None

• • Differences of opinion: None

• • Implementation considerations: Access to qualified, multidisciplinary team members or coaches; many current healthcare payers do not provide coverage/reimbursement for visits with HWCs which limits accessibility; handouts that describe the different approaches to achieving person-driven, sustained positive behavior change

Supporting Text

The purpose of this statement is to promote sustained, person-driven behavior change. As we partner with our patients, we need to approach care through the lens of “work with the being; not just the doing” and that we are caring for the whole person, not just the person’s health condition.

Robust evidence from systematic reviews and RCTs underscores the effectiveness of HWC-centered interventions in managing T2D, though results were less consistent when coaching was delivered via telemonitoring and mobile phones.^{161,163-165,311,477-483} These compelling data offer valuable insights for practice guidelines as interventions that not only focus on disease management, but also notably emphasizes a “lifestyle first, lifestyle always” approach. Health coaching can reduce HbA1c levels after 4 to 6 months,^311,484,485 comparable to the effect of pharmaceutical interventions. ⁴⁸⁴ Motivational interviewing, a key technique in health coaching, can improve metabolic control and psychosocial aspects for people with diabetes, including decreased blood sugar levels after meals and lower blood pressure. ¹⁶⁵

Workplace programs, inspired by the DPP, were found to significantly increase the likelihood of participants losing at least 5% of their body weight by nearly 4 times when compared to non-workplace program participants. ⁴⁷⁸ Health coaching can improve physical measurements and self-confidence in managing a chosen eating plan among participants ⁴⁷⁷ and can result in higher weight loss and ability to achieve target blood sugar levels compared to standard care (39% vs 20%). ¹⁶¹ These studies collectively highlight the crucial role of health coaching in enhancing health outcomes for individuals with T2D and provide evidence for incorporating at least 12 health coaching sessions over a minimum of 6 months to see meaningful health improvements. ⁴⁸³

For GDM, evidence regarding health coaching is limited and derived mainly from small studies. Pregnant women at 12-14 gestational weeks who received health and wellness coaching (HWC) interventions for 8 weeks limited their weight gain more effectively than those who did not, reducing their weight gain by about 2.5 kg more than the control group. ⁴⁸⁶ This significant reduction in weight gain can decrease the risk of developing GDM. In people with GDM, telephone coaching over 4 weeks, when compared to standard of care (no HWC), resulted in a 3.2% relative reduction in fasting blood sugar and a 1.4% relative decrease in HbA1c, indicating better glucose management. ⁴⁸⁷ Moreover, HWC improved self-care behaviors by 22.5%, while depression scores decreased by 11.4%, highlighting the program’s effectiveness in enhancing both diabetes management and mental health for these participants. ⁴⁸⁷

Digital technology integration to support T2D prevention was studied in the context of coaching, tracking, social support, goal setting, feedback, and/or self-monitoring. A meta-analysis found that these technologies can optimize digital diabetes prevention interventions to achieve significant weight loss of at least 3% weight loss in 6 months or under, and at least 5% weight loss over 1 year. ⁴⁸⁸

Evidence from an umbrella review of 41 systematic reviews across 33 countries, utilizing diabetes self-management education and support interventions, highlighted a significant reduction in HbA1c levels (0.25% to 0.5%), underlining its clinical importance in mitigating diabetes-related complications. ⁴⁸⁹ BMI, weight, and blood pressure, however, did not consistently show significant changes, except for a small, sustained decrease in BMI (0.51 kg/m²). Self-management support was significantly successful as a culturally tailored intervention, particularly for minority ethnic groups, in improving glucose management. Therefore, clinicians and HCPs must carefully and sufficiently facilitate and support individuals in moving toward fully independent self-management integration, while leveraging technology to improve engagement and support, when possible. By increasing the clinical application of person-centered, self-empowering modalities like HWC, clinicians and HCPs can help people with diabetes achieve improved self-management outcomes while also respecting cultural preferences.^490,491

Substantial evidence highlights the critical role of integrating CBT-type interventions with tailored eating patterns and lifestyle interventions in diabetes care, to effectively address both the physical and psychological health of people living with T2D.^{267,362,492-500} CBT interventions led to a meaningful decrease in blood sugar levels by about 0.3%, and reduced depression symptoms by nearly 3 points on average, showcasing CBT’s effectiveness in both managing diabetes and improving mental health. ²³ In a separate study, individuals receiving a more intensive behavioral weight loss treatment experienced an average weight loss of 4.2 kg, significantly more than those in a less intensive program. ⁴⁹⁵ These findings underscore the efficacy of CBT-based interventions, tailored to individual needs and preferences, in the management of diabetes, addressing the physical, emotional, social, physiological, and psychological aspects for comprehensive, meaningful, thoughtful, and individualized care. Table 19 summarizes the strength of evidence of these different person-driven, behavior-change interventions for diabetes, prediabetes, and GDM.

Table 19.

Evidence Strength for Based Person-Driven, Sustained Positive Behavior Change Interventions for Diabetes, Prediabetes, and Gestational Diabetes Management.

Intervention Type	Technique	Proposed Frequency/Dosage	Key Outcomes	Evidence Strength
Health and Wellness Coaching (HWC)	Behavior changes related theories, motivation, and accountability, health education and promotion processes. Hybrid method of delivery allowed. No diagnosis or prescription of treatment are recommended directly through this approach.	Average of ≥12 sessions over ≥6 months Person-driven; coach guided	Improved glucose management and weight management (≥5% weight loss); enhanced self-care and mental health	Medium - low (RCTs, SRs)
Gestational Diabetes Management (GDM)	Coaching-based, lifestyle tailoring Hybrid method of delivery allowed, though evidence comes mainly from tele-coaching.	Range of 4-8 weeks HWC program	Reduced fasting blood sugar by 3.2%, HbA1C by 1.4%, enhanced self-care by 22.5%, decreased depression by 11.4%	Low (2 small studies)
Digital Diabetes Prevention Interventions (DDPI)	Coaching- and counseling-informed approaches, risk assessment, tracking, social support, goal setting, feedback, self-monitoring Hybrid method of delivery.	Up to 12 months 30-60 min sessions Structured	Improved glucose management and weight management (weight loss); enhanced self-care	Medium – low (small RCTs)
Diabetes self-management education and support	Culturally tailored intervention leverages technological approaches, allows tracking progress and timely feedback.	Variable based on individualized care	Sustained decrease in BMI and HbA1c	Medium (Umbrella review of 41 systematic reviews)
Cognitive Behavioral Therapy (CBT)	Behavior-centered theories (e.g., cognitive theory, behavioral psychology, empirical validation). Hybrid method of delivery allowed. Diagnosis, interventions, or prescription of certain treatments can be part of this approach.	Variable based on individualized care; structured, time-limited, and problem-focused	Improved glucose management and weight management (weight loss); enhanced self-care and mental health	Medium (RCTs, systematic reviews)

Keywords: BMI, body mass index; RCT, randomized controlled trial.

By incorporating behavior change-centered interventions into prediabetes and diabetes management, clinicians and HCPs can support discussions, integration, and/or maintenance of the lifestyle medicine pillars into diabetes by empowering the activation of individuals, enhancing capacity, identifying threats of care burden, and ensuring an informed SDM process. Table 20 provides a framework for actionable steps, referral approaches, and resources to assist clinicians and HCPs in their management discussions and plans. Integrating these interventions into diabetes management emphasizes a holistic approach that considers the individual’s unique needs and preferences, fostering collaborative partnerships between clinicians, HCPs, and individuals in achieving optimal health outcomes. Table 21 provides clinicians and HCPs with practical tips, techniques, and examples they can leverage to create a medium for behavior change-centered conversations. Table 22 additionally provides practical methods for using evidence-based approaches to achieve person-driven, sustained positive behavior change.

Table 20.

Person-Driven Diabetes Behavior Change Interventions: Types, Framework, and Resources.

Intervention Type	Characteristics	Techniques	Tools	Implementation Tips/Dosage	Engagement Timing	Referral Guidance
Motivational Interviewing a	Person-centered counseling style.	OARS a	In-person, telemedicine, messaging.	Follow person’s agenda, set pace for change, emphasize autonomy and collaboration.	Initial diagnosis, periodic follow-ups, when person is having difficulty achieving desired progress.	If no improvement, refer to health coach or psychologist.
HWC	Creating partnerships through a person-centered process rooted in the sciences of behavioral change, motivation, lifestyle and well-being, neuroscience, and health education and promotion.	Goal-setting frameworks (e.g., SMART), self-discovery, activation, active learning, motivation, accountability strategies, empathetic listening, brainstorming, health education and promotion processes.	In-person, telemedicine, or hybrid, leveraging technological support tools.	Establish clear, person-driven goals; ensure regular follow-up for accountability. Consider ≥12 sessions over ≥6 months.	As part of initial treatment plan; ongoing support.	If goals are not met, consider intensifying support or referral to specialized care.
CBT	Psychological intervention to modify dysfunctional thoughts and behaviors.	Structured sessions, behavioral activation, cognitive restructuring.	In-person, telemedicine, or hybrid, leveraging technological support tools.	Foster self-awareness of thoughts and behaviors, encourage homework tasks, use Socratic questioning. Session frequency and duration should be tailored to individual needs.	Persistent harmful behavior patterns, high stress or poor mental health impacting diabetes management.	If no progress with initial counseling or coaching, or if psychological disorders are present.
Continuous engagement & education	Lifelong learning and adjustment.	Continuous education, regular updates on condition management.	Healthy lifestyle educational websites, e-learning modules, webinars, apps.	Provide ongoing education, adapt to new research and guidelines, foster lifelong health literacy through person-centered follow-ups.	Lifelong, with emphasis during transitions in care.	Per individual needs; per HCP recommendations.

^aSee KAS 2 FAQ key words: OARS, open questioning, affirming, reflecting, summarizing; HWC, health and wellness coaching; CBT, cognitive behavioral therapy; SMART, specific, measurable, achievable, relevant, and time-bound.

Table 21.

Practical Tips and Techniques Used in Behavior Change-Centered Interventions.

Approach Characteristic	Description	Application in Interventions	Examples of Lifestyle Changes Relative to Prediabetes or Diabetes
SMART: Specific, Measurable, Achievable, Relevant, Time-bound	A framework to support a goal-setting process to enhance motivation, focus efforts, and track progress in lifestyle modifications.	Guides individuals in defining specific, measurable objectives for personalized goal-setting, monitoring outcomes, and celebrating achievements.	Specific: Exercise by brisk walking Measurable: 45 min/day; 4 days/week. Mark on calendar as a reminder) Attainable: Early morning when I have quieter time for myself is my highest potential for success Relevant: Start with 15 min/daily first 2 weeks >> add 5 min/week onwards Time: Achieve full adherence in 3-months
OARS: Open-ended questions	Encouraging individuals to express their concerns, preferences, and goals openly, facilitating personalized and curious conversations.	Inviting individuals to share their thoughts and feelings freely, fostering deeper understanding and engagement.	Person: “I’m struggling to stick to my meal plan.” Clinician or HCP: “I can imagine it must be very demanding with all your other responsibilities. Tell me more about what’s been the most challenging for you?” Person: “Well, sometimes I feel like I don’t have enough time, and other times I just lack motivation.” Clinician or HCP: “What are some small steps you could take as a first step to save time and to keep motivation going?” Person: “Maybe I could try prepping my meals in advance to save time.” Clinician or HCP: “Let’s break it down into actionable steps.” Person: “I can start by planning out my meals 3 days a week for starters. That sounds doable. I will put them on the calendar to remind me.” Clinician or HCP: “Excellent. Remember, small progress is progress. Let’s summarize our plan.”
OARS: Affirming	Acknowledges strengths and positive behaviors, fostering self-confidence.	Validates efforts and progress in diabetes management, creating a supportive atmosphere.
OARS: Reflecting	Actively listens, paraphrases, and clarifies to deepen understanding.	Conveys empathy, enhances engagement, and supports collaborative problem-solving.
OARS: Summarizing	Synthesizes key points and reinforces progress in diabetes management.	Consolidates information, promotes reflection and clarity, and ensures agreement and continuity of care.
Empathetic listening	Attentively hears and understands concerns, fostering trust and validation.	Creates a safe, supportive space for discussing challenges and goals in diabetes management.	Person: “I feel overwhelmed managing my diabetes.” Clinician or HCP: “You have been working hard. That must feel challenging sometimes.”
Brainstorming	Generates diverse ideas collaboratively to address challenges in lifestyle changes.	Encourages exploration of innovative approaches and practical strategies for healthy behaviors.	Person: “I need some meal inspiration. I feel stuck.” Clinician or HCP: “Would you like to brainstorm together to come up with 2 ideas of some healthy foods you enjoy?” Person: “I like grilled veggies. I like to change up my meals so I don’t become bored with the food.” Clinician or HCP: “Ok, how can you bring your 2 ideas together?” Person: “I want to try different seasonings to keep my meals interesting. Do you have any other ideas?” Clinician or HCP: “How about adding one new vegetable you have not tried before?” Person: “I like that. I’ll start from there.”
Sustained change & accountability	Establishes consistent habits, monitors progress, and fosters accountability in lifestyle modifications.	Emphasizes setting realistic goals, implementing sustainable changes, and tracking behaviors for lasting success.	Person: “I’m struggling to stay consistent with my exercise routine.” Clinician or HCP: “What has worked for you in the past?” Person: “I used to log my workouts in a fitness app.” Clinician or HCP: “Logging is a great way to provide accountability and motivation. What would be helpful to make it happen again?” Person: “I will reinstall the app. That is doable.”
Patient’s agenda & pace	Prioritizes individual preferences, allowing them to set goals and pace of progress.	Engages individuals in collaborative discussions, respecting autonomy and promoting self-efficacy.	Encouraging individuals to share their personal health goals, preferences, and priorities through various techniques (e.g., empathetic listening, OARS)
Telemedicine & digital communication	Utilizes technology for accessible, personalized diabetes care and support.	Facilitates virtual consultations, education sessions, and remote monitoring to overcome barriers and enhance engagement.	Participating in virtual diabetes education classes, webinars, or support groups to gain knowledge, skills, and peer support for managing diabetes effectively.
Multidisciplinary team engagement	Collaborates among clinician or HCPs to provide comprehensive diabetes care.	Integrates medical management, lifestyle interventions, and psychosocial support for optimal health outcomes.	Engaging in collaborative care meetings with a multidisciplinary team to discuss treatment plans, address challenges, and coordinate interventions for managing prediabetes or diabetes effectively.
DSMES and lifestyle pillars alignment	Integrates diabetes self-management education with lifestyle interventions.	Tailor education programs to incorporate lifestyle-focused services, aligning with individuals’ preferences and socioeconomic factors.

OARS, open-ended questions, affirmations, reflections, summaries; HCP, healthcare professionals; DSMES, diabetes self-management education and support.

Table 22.

Handout for Individuals 8: FAQ for Healthcare Professionals on Practical Methods to Using Evidence-Based Approaches to Achieve Person-Driven, Sustained Positive Behavior Change.

Q1: Why are behavior change-centered interventions important in diabetes care?

A1: These interventions are crucial as they empower individuals to take an active role in managing their diabetes. They can lead to improved glucose management, better self-management skills, and enhanced overall well-being—thus, supporting the mission of DM clinicians.

Q2: What are the broad categories of approaches in behavior change-centered interventions?

A2: The main categories include Health and Wellness Coaching (HWC), Cognitive Behavioral Therapy (CBT), Self-Management Education and Support (DSMES), and Digital Diabetes Prevention Interventions (DDPI). The Five As are also used in counseling individuals about behavior change. They include Ask, Assess, Advise, Agree, Assist. 501

Q3: What is OARS and how can it be used in practice?

A3: OARS is a person-centered communication technique used in motivational interviewing that includes:

• Open-ended questions: Encourages detailed responses for better understanding.

• Affirmations: Strengthens motivation with positive reinforcement.

• Reflections: Shows active listening and understanding of the person’s perspective.

• Summaries: Validates the conversation and clarifies the next steps.

In practice, use OARS to guide conversations with individuals about their health behaviors and goals.

Q4: Can you provide an example of how to use an open-ended question with a person?

A4: Instead of asking, “Did you check your blood sugar levels regularly?” you might ask, “Can you tell me about your experience with monitoring your blood sugar levels this week?”

Q5: How do affirmations enhance person communication?

A5: Affirmations like “You’ve made a significant effort in adjusting your eating plan” acknowledge progress and effort, boosting confidence and motivation.

Q6: When should I employ reflective listening?

A6: Reflective listening should be a constant practice. For instance, after a person describes their challenges with exercise, you could reflect by saying, “It sounds like finding time for exercise has been a real challenge for you.”

Q7: Why are summaries a powerful tool in-person conversations?

A7: Summaries restate what the person has shared, demonstrating that you have listened and understood, which helps build trust and sets the stage to call out change talk and for creating action plans.

Q8: What can I use now in my practice to facilitate behavior change?

A8: Begin incorporating the OARS technique into your person conversations immediately. It is a simple yet effective way to engage people and encourage them to talk more about their behaviors, concerns, and goals.

Q9: When should I refer a person to a specialist, and to whom should I refer?

A9: Refer to a specialist when:

• The person’s needs exceed the scope of your practice, experience, and/or time feasibility.

• There is a lack of progress with current interventions.

• Complex psychological issues are affecting their diabetes management. Specialists can include certified health coaches for HWC, psychologists or therapists for CBT, diabetes educators for DSMES, or tech consultants for DDPI.

Q10: How do digital tools fit into these behavior change approaches?

A10: Digital tools can enhance traditional interventions, offering remote monitoring, facilitating telehealth coaching, and support for goal setting and feedback. They can be particularly effective for engaging people in their self-management between visits.

KAS 13: Establishing a Plan for Continuity of Care

For adults with prediabetes, T2D, or a history of GDM, the clinician or HCP should establish a plan for continuity of care that prescribes lifestyle interventions and specifies the frequency of visits, anticipated duration of care, potential need for adjustments of pharmacologic therapy, and expectations regarding the individual’s engagement. Strong recommendation based on RCTs, systematic reviews, and observational studies with a preponderance of benefit over harm.

Action Statement Profile

• • Quality improvement opportunity: To promote adherence to established lifestyle interventions and follow-up plans to optimize continuity of care. (National Quality Strategy Domain: Patient Safety; Person- and Family-Centered Care; Effective Communication and Care Coordination; Prevention and Treatment of Leading Causes of Morbidity and Mortality)

• • Aggregate evidence quality: Grade B, based on over 20 systematic reviews, several meta-analyses, and RCTs that demonstrate consistent benefits related to continuity of care for people with T2D

• • Level of confidence in evidence: High

• • Benefits: Maintain person engagement in care; promote success and sustainability; establish clear goals and expectations regarding the need for future care; and assess the need to alter the management plan based on the person’s needs

• • Risk, harm, cost: Time counseling individuals and expense of follow-up visits (e.g., treatment, medical supplies, transportation etc.)

• • Benefit-harm assessment: Preponderance of benefit over harm

• • Value judgments: There is a perception among the GDG that continuity of care can be inadequately discussed or specified as part of the person’s care plan

• • Intentional vagueness: The specifics regarding frequency, duration, type of intensity of follow-up are based on the specific needs of the individual

• • Role of patient (individual) preferences: Large role for person preferences based on continuity of care

• • Exceptions: None

• • Differences of opinion: None

• • Implementation considerations: Challenges to providing continuity of care, especially in at-risk individuals or underserved communities, which include: barriers to accessing care; lack of adherence to follow-up; technology limitations; cognitive barriers; cost of transportation, supplies, and treatment; access to comprehensive interdisciplinary team; and time in gathering information and counseling

Supporting Text

The purpose of this statement is to describe considerations for establishing a comprehensive plan of care for lifestyle interventions, specifying frequency of visits, duration of care, oversight for pharmacologic therapy, and potential follow-up for people with prediabetes, T2D, or a history of GDM.

Continuity of care, for the purpose of this guideline, is defined as the ongoing process followed by the interdisciplinary care team to collaborate for the purpose of providing high-quality care over time that supports positive experience for individuals and a sustained, stable relationship with the person’s clinicians (Figures 28 & 29). Continuity of care is naturally suited to lifestyle treatment.

Figure 28.

Decision cycle for person-centered glycemic management in type 2 diabetes. Health care professionals can engage individuals in managing glucose levels through a continuous and cyclical decision-making process. This approach emphasizes person-centered care and the importance of building lasting relationships to support the adoption of lifestyle changes. Key interactions focus on fostering these connections to effectively encourage positive health behaviors.

Figure 29.

Key questions to ask my healthcare professional at diabetes follow-up visits. This condensed handout for individuals can be used to facilitate effective communication with the health care team, by prompting the person to keep track of their biometrics and to organize their questions, appointment schedules, and other key aspects of their care. The overall goal is to optimize the quality of the time spent during appointments and to provide documentation of their interactions.

To further enhance continuity of care, clinicians should maximize their interactions with other available team members such as diabetes educators and dietitians to increase care continuity and coordination.^502,503 Clinicians can employ several techniques (Table 23) to enhance lifestyle changes for people with T2D such as scheduling regular follow-up visits, using continuous glucose monitoring when available, and referring to other health care team professionals for further education and support. Both traditional office visits or virtual appointments using telemedicine, virtual group sessions, or other digital platforms are all effective ways to engage individuals in achieving lifestyle changes, reaching glycemic goals, and ensuring safety.^504,505

Table 23.

Key Components in Continuity of Care for People With T2D Who Are Being Treated With Lifestyle Interventions.

Component	Evidence	Recommendations
Frequency of visits and duration of care	Extended care, including more frequent, and longer person contact improves adherence to behavior goals and aids in maintaining health behaviors.506-508	Clinicians should schedule additional visits closely following the first initial visit when lifestyle is discussed, and then as often as possible given restrictions based on billing/reimbursement, availability of the clinicians, and person need for further education and support.
Glucose monitoring	Lifestyle changes, particularly calorie restriction and whole-food, plant-predominant eating plan interventions, have been shown to reduce blood glucose, sometimes rapidly.307,309,430 Glucose self-monitoring should be encouraged as a way to increase person motivation as well as to enhance safety.509,510	Clinicians should, when possible, use continuous glucose monitoring (CGM) devices to track glucose levels during the first month and beyond lifestyle changes. When the use of CGM is not possible, frequent person self-monitoring is indicated, as often as twice daily during the first week of eating plan interventions targeting remission, as described in KAS 8.
Medication management	Regularly scheduled visits with the clinician or HCP demonstrated improved ability to monitor pharmacologic agents to detect or prevent untoward effects such as hypoglycemia, drug-to-drug interactions, falls, or weight gain. Prompt modification of the pharmacologic regimen is advised when unsafe or side effects are detected.504,505,511-513	See KAS 14 for specific recommendations on medication management.
Use of technology	The use of multiple platforms between the health care professional and the person (face-to-face, telemedicine, virtual follow-up, AI driven) consistently yields improved glucose management, weight loss, and safety for people with diabetes.162,514-521	Telemedicine, automated follow-up emails, and referrals to supportive social media accounts should be considered to help create an environment conducive to sustaining healthy lifestyle changes.
Referrals to other team members and shared medical appointments	Referrals to dietitians, Certified Diabetes Care and Education Specialist or diabetes educator, and health coaches have been shown to improve blood glucose management when used in conjunction with encounters with the PCP or endocrinologist for behavior change.522-524 Shared medical appointments also yield favorable outcomes related to weight loss and improved glycemic outcomes.525,526	When possible, clinicians should refer to other available team members for additional contact and extended follow-up.
Follow-up	Evidence shows that fostering continuity of care with regular follow-up visits promotes successful adoption of lifestyle interventions and person self-care engagement.163,263,521,527-529 Maintaining that relationship for regularly scheduled follow-up visits for the duration of the condition favors continuity of care and person metrics.527,530,531	When beginning intensive, therapeutic lifestyle changes with people diagnosed with T2D, increased attention should be placed on person monitoring in the first few weeks, especially if the person indicates they are ready and willing to make substantive eating plan changes. Ongoing follow-up visits should be scheduled regularly to assess maintenance of lifestyle changes, based on a person’s characteristics and needs.

For people with prediabetes or a history of GDM, similar measures to interrupt the trajectory to T2D can be employed. For people with prediabetes, the American Diabetes Association ³⁵ recommends referral to lifestyle behavior-change programs that emphasize weight loss, a healthy reduced-calorie eating plan, and regular physical exercise such as described in the DPP. Follow-up visits with clinicians and other interdisciplinary health care professionals such as dietitians, health educators, lifestyle coaches, pharmacists, mental health professionals, and community health workers have yielded significant reductions in weight and improved glucose management. Using technology to deliver preventive interventions (via smart phones, internet-based programs, telehealth visits, and other digital platforms) is effective in reaching individuals who can benefit from diabetes prevention measures.

The American Diabetes Association ⁵³² and the American College of Gynecology ⁵³³ recommend regular follow-up visits for individuals following a GDM event for lifestyle and pharmacologic interventions, follow-up testing of glucose levels at 12 weeks postpartum, and regular glucose monitoring every 1-3 years to prevent the development of T2D. After the postpartum period, primary care follow-up is recommended to further ensure continuous monitoring and lifestyle management.

KAS 14: Adjusting Pharmacologic Therapy

For adults with prediabetes, T2D, or a history of GDM, the clinician or HCP should adjust the type and dosing of an individual’s pharmacologic therapy based on the impact of lifestyle intervention on their medication needs. Recommendation based on observational studies, with a preponderance of benefit over harm.

Action Statement Profile

• • Quality improvement opportunity: To assess whether adjustments are necessary to the person’s pharmacologic therapy to avoid adverse events and to ensure adherence to lifestyle intervention and as goal-directed therapy to optimize health outcomes in people with prediabetes or T2D. (National Quality Strategy Domain: Patient Safety; Prevention and Treatment of Leading Causes of Morbidity and Mortality).

• • Aggregate evidence quality: Grade B, regarding the need for deprescribing, dangers of hypoglycemia, and lack of previous guidance on deprescribing based on 8 systematic reviews. Grade C, regarding the likelihood of lifestyle interventions to necessitate deprescribing and potential hypoglycemia based on several non-randomized, observational, or alternative method designed studies

• • Level of confidence in evidence: Medium

• • Benefits: Avoid adverse effects from hypoglycemia or overmedication; avoid hypotension; minimize weight gain; enable prescribed lifestyle changes; and promote sustainability of changes

• • Risk, harm, cost: Person anxiety regarding changes in therapy; some medications may be costly, or not covered by insurance; short-term, permissive hyperglycemia

• • Benefit-harm assessment: Preponderance of benefit over harm

• • Value judgments: There is a perception among the GDG that people may experience anxiety about lifestyle interventions because of the potential impact on their current medications; perception of lack of awareness (for both medical teams and people) about anticipating the need to adjust pharmacologic therapy once lifestyle interventions are implemented

• • Intentional vagueness: None

• • Role of patient (individual) preferences: Moderate for shared decision-making regarding adjustments to medications

• • Exceptions: None

• • Differences of opinion: None

• • Implementation considerations: Need for frequent follow-up to monitor impact of medication changes; glucose monitor access; anxiety about deprescribing medications; and access and availability of CGM

Supporting Text

The purpose of this statement is to provide guidance to clinicians for adjusting the type and dosing of pharmacological therapy for people with T2D who are engaging in intensive or moderate therapeutic lifestyle change interventions, particularly when the goal is to achieve remission. Any adjustment should also take into account how the medication change may impact comorbid conditions, if present, such as chronic kidney disease, heart failure (with reduced or preserved ejection fraction), or a history of myocardial infarction.

Deprescribing medications in people with T2D has historically been done to reduce polypharmacy^534-536 and inappropriate medications,^537-540 most commonly in older adults. Pharmacologic down-titration can occur during scheduled follow-up visits in person or on telehealth to prevent adverse events and to promote better outcomes.^{504,511,514,541-544} Chapter 13 of the ADA guidelines, which focused on older adults, specifically recommends efforts be made to reduce hypoglycemia risk and to simplify treatment plans (level B). ⁵⁴⁵

Hypoglycemia has been identified as a risk in multiple contexts, including in cases of weight loss, ⁵⁴⁶ following bariatric surgery among people with T2D, ⁵⁴⁷ over prescription among the elderly, ⁵⁴⁸ low-carbohydrate eating plans,^549,550 energy-restricted eating plans,^312,326 and low-fat, whole-food, plant-based eating plans^306,309 (see KAS 8). Weight loss may also occur when using GLP-1 receptor agonists, but only a minority of T2D adults lose more than 5% of their weight with these medications, which is less than observed in clinical trial participants. ⁵⁵¹ Collaborating closely with pharmacists, as part of the interdisciplinary team that includes nurses, dietitians, health coaches, and certified diabetes care and education specialists (CDCES), ⁵⁰⁴ is recommended to monitor changes in needs for glucose-lowering and anti-hypertensive medications. We recommend clinicians be proactive in reducing diabetes medications associated with hypoglycemia risk, for people who will incorporate strong, consistent, lifestyle improvements (especially nutrition and exercise) (Figures 30 and 31). Should hypoglycemia occur, clinicians should follow the established standards of care for management of hypoglycemia, which are beyond the scope of this guideline.

Figure 30.

Deprescribing considerations. Overall considerations for proactive pharmacologic management in deprescribing glucose-lowering medications. ⁵⁷³

Figure 31.

Deprescribing approach. ACLM framework for deprescribing glucose-lowering medications in the context of lifestyle interventions. ⁵⁷³

A qualitative study among stakeholders in a post-acute home healthcare context identified 4 essential tasks to effective deprescribing. ⁵⁵² These 4 steps are presented in Table 24, with deprescribing considerations in a lifestyle context.

Table 24.

Four Steps for Deprescribing Glucose-Lowering Medications in a Lifestyle Treatment Context.

Steps for Deprescribing Glucose-Lowering Medications	Implementation Considerations
(1) Ongoing review and assessment of medication use	Review needs to be ongoing as glucose management and medication needs will change based on adherence to treatment, duration of adherence, and intensity of treatment. Adjustments made at the outset of lifestyle treatment will need to be revisited.
(2) Person-centered and individualized plan of deprescribing	SDM about deprescribing decisions is ideal. People should be educated about the effects of medications, risks of both medications and deprescribing, lifestyle alternatives to pharmacologic therapy, and other considerations such as cost, and should be involved in creating a medications plan with the clinician.
(3) Timely and efficient communication among members of the care team	Effective communication among all members of the interdisciplinary care team is essential, as behavior changes, especially intensive ones, may have strong effects on medication needs and risk for hypoglycemia. All members of the care team should share information in such a way that makes rapid responses or adjustments in communicating with the person possible.
(4) Continuous and tailored medication education to meet the person’s needs	People should be educated on an ongoing basis regarding the risks of medications, benefits, other side effects, and the importance of communication with their clinician about behavior changes because of the immediate and potent effect on blood glucose.

While deprescribing does not equal decreasing treatment efficacy, education of individuals may be aided with the handout (Figure 32) on glucose-lowering medications. In the primary care setting, reported use of “potentially inappropriate medications” prompted greater oversight from the physician, closer review of medications, and enhanced medication reconciliation without lowering treatment intensity. ⁵⁵³ These results support the benefit of closer monitoring when delivering any treatment protocol, especially where changes may occur rapidly in response to adherent behavior.^306,309 Lifelong diabetes management should educate and empower individuals to enhance their self-efficacy, and some amount of deprescription, even without lifestyle changes, may be feasible.^511,543 Moreover, physical activity has demonstrated positive effects in disease control outcomes, reducing, by one, the number of medications required by older veterans after one year of beginning an exercise program. ⁵⁵⁴

Figure 32.

Initiating lifestyle therapy. Handout for individuals with advice on when a person should contact their clinician before starting lifestyle interventions.

There is growing evidence to recommend deprescribing diabetes medications in response to behaviors recommended in this guideline, namely a low-fat, whole-food, plant-predominant eating plan, which has the potential to improve the response to antihyperglycemic/antidiabetic medications.^306,309,505 The opportunity to reduce medications following lifestyle changes should be discussed with people as a potential motivator, as much medication non-adherence generally is due to person preferences for fewer medications ⁵⁵⁵ and perceived drawbacks to taking medications.^556,557 Additionally, introducing deprescribing by the clinician can help people with their willingness to reduce medications. ⁵⁵⁸ Nevertheless, we recognize the cardiovascular and renal protection from newer antidiabetic medications such as Glucagon-like peptide-1 receptor agonists (GLP1-RA), Glucose-dependent Insulinotropic Polypeptide (GIP)/ Glucagon-like peptide-1 receptor agonists (GIP/GLP-1 RA), and Sodium-glucose cotransporter-2 inhibitors (SGLT2i) for people with T2D and pre-existing cardiovascular disease or diabetic kidney disease.^559-561 These medications may continue for these other indications, and clinicians and HCPs will need to determine persistence of indication outside glucose management (e.g., after achieving diabetes remission) and subsequent monitoring of dosing and safety.

There is limited evidence from RCTs demonstrating best practices on how to deprescribe antihyperglycemic medications, ⁵⁶² either in terms of the schedule or order of priority. Clinicians should use best practices, based on the limited available evidence, ⁵⁰⁴ to perform monitoring and medication deprescribing aiming first at reducing the risk for hypoglycemia/weight gain (insulin, SU). ⁵⁰⁴ Individuals who are at high risk of developing hypoglycemia should be monitored more carefully. In addition to those taking medications known to cause hypoglycemia, or with a history of the condition, the ADA ²²² has also identified specific behaviors and characteristics as high risk. These include older age or pre-school age, impaired kidney or liver function, untreated pituitary, adrenal, or thyroid insufficiency, cognitive impairment or impaired awareness of hypoglycemia, longer duration of diabetes or insulin use of greater than 5 yrs, and behaviors including alcohol use, eating disorders, or irregular eating. ⁵⁶³

One frequent recommendation concerning pharmacologic interventions for older individuals includes using safer agents such as GLP-1 RAs since hypoglycemia and weight gain are usually not associated with them, ⁵⁶⁴ albeit excessive fat-free mass or sarcopenia may be a concern.^565,566 Notwithstanding, individual preference should be considered as part of shared decision-making, especially since another consideration may be cost (with opting to drop the costliest medication first). This strategy has also been noted by the American Association of Clinical Endocrinologists. ⁵⁶⁷

Insulin specifically requires particular consideration because of the varying characteristics of insulin, individual characteristics such as starting HbA1c and glycemic variability, and the potent effect of their use. A review of clinical trials that summarized initial dose adjustments to insulin regimens during initiation of GLP-1 receptor agonists ⁵⁶⁸ was consistent in considering the individual starting HbA1c and variability while decreasing insulin dosing empirically. ⁵⁶⁸ In keeping with established CPGs,^569,570 people on insulin therapy should use CGM to optimize glucose management and to provide timely hypoglycemia alerts, especially during the initial weeks of an intensive lifestyle change. Additionally, using a continuous glucose monitor has improved adherence to eating plans, healthy eating, and physical activity,^571,572 which may help the person better implement the lifestyle therapy plan.

Though the intervention is different from that recommended here, some perspectives on low-carbohydrate eating plans have been discussed that identify the priority for deprescribing to be medications that might cause hypoglycemia, namely sulfonylureas, meglitinides, and insulins.^549,550 A practice audit conducted among primary care practices in the UK also identified sulfonylureas and insulin as those most likely to cause hypoglycemia in the elderly. ⁵⁷²

Considering the special considerations for insulin, ACLM recommends an approach for empiric reductions in medication dosages that mirrors the established approach in the American Association of Clinical Endocrinology’s (AACE) algorithm for increasing insulin therapy for hyperglycemia ⁵⁶⁷ (Table 25). This algorithm also recommends using basal analog insulins, including glargine, or Degludec, preferably over human insulins such as neutral protamine Hagedorn (NPH) to reduce hypoglycemia risk. Similarly, rapid-acting insulin analogs are preferred over human insulin preparations (e.g., regular insulin) for prandial dosing. Because of the longer half-life of insulin Degludec, slower titration every 3 to 5 days is recommended. Please note that Tables 25–27, Recommended lifestyle interventions, risks of adverse events, and deprescribing treatment protocol to avoid hypoglycemia, are to be viewed concurrently.

Table 26.

Recommendations for Empiric Basal and Bolus Insulin Dose Reduction With Initiation of Intensive Lifestyle Intervention.

Glucose Management at Baseline (Over the Last 7-14 Days)	Basal Insulin Dose Reduction (%)	Bolus Insulin Dose Reduction (%)
Average FPG <130 mg/dL	20-40	50
Average FPG 130-200 mg/dL	20	25
Average FPG >200 mg/dL with severe risk for hypoglycemia (see ADA table), for example, glycemic variability, hypoglycemia unawareness, or hx of severe hypoglycemia	10-20	25
Average FPG >200 mg/dL without severe risk for hypoglycemia	10	20

FPG, fasting plasma glucose.

Table 25.

Recommended Lifestyle Interventions, Risks of Adverse Events, and Deprescribing Treatment Protocol to Avoid Hypoglycemia.

Row #	Intervention Described in KAS#; Recommended Lifestyle Intervention	Likelihood of Adverse Events Among Adherent Individuals (Hypoglycemia, Hypotension)	Recommended Approach to Monitoring	Considerations and Recommended Schedule for Deprescribing to Avoid Hypoglycemia a
A	KAS 8; diabetes remission-targeted eating plan consisting of low-fat, whole-food, plant-predominant pattern	Moderate to high	Continuous glucose monitoring (CGM) when possible; when not feasible, self-monitoring, up to 4 times daily during at least the first 2 weeks of intervention	See Figure 31 above
B	KAS 8; diabetes treatment eating plan for improved glucose management consisting of plant-forward patterns such as Mediterranean eating pattern, DASH, DGA, etc.	Moderate	Continuous glucose monitoring (CGM) when possible; when not feasible, self-monitoring, up to 4 times daily during at least the first 2 weeks of intervention	See Figure 31 above
C	KAS 7; Diabetes prevention diet, including Med diet, DASH, DGA, etc.	Low	Continue self-monitoring blood glucose as per usual regime	NA, if people are non-medicated;
D	KAS 4 and KAS 5; Physical activity prescriptions to follow Physical Activity Guidelines for Americans	Low to moderate	Continue self-monitoring blood glucose as per usual regime	Continue to review medication needs as usual
E	KAS 6; healthy sleep prescription to improve sleep habits and follow AASM & SRS b guidance for adults to sleep 7+ hrs/night	Low to moderate	Continue self-monitoring blood glucose as per usual regime	Continue to review medication needs as usual
F	KAS 10; stress management plan to reduce acute stress and better manage chronic stress	Low	Continue self-monitoring blood glucose as per usual regime	Continue to review medication needs as usual
G	KAS 9; social connection plan to develop healthy social networks	Low	Continue self-monitoring blood glucose as per usual regime	Continue to review medication needs as usual
H	KAS 11; reduction or termination of alcohol, tobacco, or other substances	Low to moderate	Continue self-monitoring blood glucose as per usual regime	Continue to review medication needs as usual
I	KAS 4-11 comprehensive intervention of multiple health behaviors including diabetes remission-targeted eating plan	High	Continuous glucose monitoring (CGM) when possible; when not feasible, self-monitoring, up to 4 times daily during at least the first week of intervention	Follow the algorithm described above in row A
J	KAS 4-11; comprehensive intervention of multiple health behaviors with no eating plan component or including a diabetes prevention eating plan or eating plan for improved glucose management	Low to moderate	Continuous glucose monitoring (CGM) when possible; when not feasible, self-monitoring, up to 4 times daily during at least the first week of intervention	Follow the algorithm described above in row A

^aAdapted from/informed by the American Association of Clinical Endocrinology's (AACE) algorithm for increasing insulin therapy for hyperglycemia. ⁵⁶⁷

^bConsistent with recommended amount of sleep for a healthy adult: a joint consensus statement of the American Academy of Sleep Medicine and Sleep Research Society. ²⁷⁴

Table 27.

Recommendations for Empiric Basal and Bolus Insulin Dose Reduction With Initiation of Moderate Lifestyle Intervention.

Glucose Management at Baseline (Over the Last 7-14 Days)	Basal Insulin Dose Reduction (%)	Bolus Insulin Dose Reduction (%)
Average FPG <130 mg/dL	10-20	20-25
Average FPG 130-200 mg/dL	10	10-20
Average FPG >200 mg/dL with severe risk for hypoglycemia (see ADA table), for example, glycemic variability, hypoglycemia unawareness, or hx of severe hypoglycemia	10	10-20
Average FPG >200 mg/dL without severe risk for hypoglycemia	No adjustment	10

FPG, fasting plasma glucose.

In summary, the above serve as guidelines to help achieve optimal person outcomes with lifestyle therapy. However, deprescribing is a highly individualized and dynamic endeavor that needs consistent follow-up, education of individuals, and tailored adaptation based on a person’s clinical response. Therefore, clinicians should use the resources and information provided herein as a broad guidance with judicious homing in on details catering to a person’s unique needs, circumstances, values, and goals.

Implementation Considerations

The complete guideline update is published as a supplement to American Journal of Lifestyle Medicine to enable reference and distribution. An executive summary of the recommendations will also be published for clinicians with a concise overview of essential text, tables, and figures. The guideline was presented to ACLM members and other clinicians as a Panel Presentation at the Lifestyle Medicine 2024 Annual Meeting, hosted by ACLM, prior to publication. A plain-language summary, aimed at empowering people in preventing progression of prediabetes and GDM for achieving remission or to improve glycemic management without medication intensification for T2D, will also be available. The implementation needs for each KAS are detailed in the corresponding action statement profile.

There are numerous challenges with regard to successful, scalable implementation of the KASs defined in the CPG; the most difficult of which include time constraints, cost and access issues in current healthcare models. Effective support for significant and lasting health behavior change typically involves frequent, ongoing continuity of care with trusted health professionals in a longitudinal manner. Providing adequate time to build strong relationships, performing necessary health behavior screenings, engaging in discussions facilitating goal-setting and exploring a person’s objectives are all key components for achieving an effective therapeutic dose for lifestyle change interventions. Clinician compensation models must reflect the additional time required to explain lifestyle interventions and engage in shared decision-making in the context of person values and preferences. The deficits inherent in current electronic health record functionality are an additional obstacle to providing comprehensive screening and longitudinal tracking of lifestyle behaviors. Documentation of SMART goals, recording lifestyle counseling recommendations, and capturing information regarding person adherence to behavior-change targets are often time-consuming and inefficient.

For many individuals, barriers to continuity of care include additional insurance co-payments, limited availability of appointments, the cost of transportation, and having a rotating group of different clinicians for follow-up appointments. These barriers can be partially addressed by fully leveraging an extended care team that all contribute to building a supportive framework for personal lifestyle change; as well as employing innovative approaches such as shared medical appointments, chronic care management services, remote monitoring of individuals and health coaching. Advocacy efforts aimed at eliminating co-pays for people engaged in a therapeutic lifestyle change intervention, and towards supporting payment of the extended care team involved, is an important strategy for achieving successful implementation of the KAS. Addressing the cognitive dissonance of the current medical model that expects to manage and pay for lifelong pharmaceutical treatment of chronic disease, but conversely expects lifelong results from a short-term coaching or health behavior-change intervention without maintaining long-term, longitudinal support, is of paramount importance in shifting the paradigm of chronic disease prevention, treatment and remission towards improved outcomes and increased clinician, HCP, and individual satisfaction.

Access issues also play a role in potential barriers to overcome. Sleep disorders such as obstructive sleep apnea and chronic insomnia are common in people with prediabetes, T2D, or a history of GDM, but appointments for evaluation and management by a sleep specialist can be challenging to obtain. Access to mental health professionals can be similarly difficult, and treatment may involve a significant financial cost for the individual due to lack of insurance coverage or frequent co-payments. Substance use disorders involving tobacco, alcohol and recreational drugs pose significant risks and can complicate glucose management; however, many communities lack access to trained health professionals able to treat these disorders. Continuous glucose monitoring is an extremely beneficial tool when utilized to educate people on the metabolic effects of their lifestyle choices; including how specific foods, lack of physical activity and sub-optimal sleep patterns affect their blood sugar levels. Unfortunately, continuous glucose monitoring is not universally covered by insurance for people with prediabetes or T2D; thereby depriving individuals of crucial knowledge they could use to better manage their chronic disease unless they are able to pay out-of-pocket for the cost of the device.

Additional barriers to implementation include considerations specific to people themselves. A whole-food, plant-predominant eating plan may not be an acceptable therapeutic option for some individuals, or they may lack convenient access to affordable, nutrient-dense whole-foods in their neighborhood. Limited culinary skills or cooking facilities can also hinder a shift in eating patterns. An individual’s personal time constraints can impact the feasibility of maintaining a regular physical activity routine, prioritizing time for optimal sleep habits, engaging in healthy stress management strategies, and preparing nutritious meals. Cultural considerations involving stigma associated with mental health disorders, preference for certain foods, and attitudes about physical activity can all impact a person’s willingness to engage in a lifestyle change approach.

When deprescribing pharmaceutical treatment for T2D is considered as a part of a lifestyle change intervention, some people, and some clinicians or HCPs, may be apprehensive about the potential risk of hyperglycemia when medications are reduced or discontinued. Comprehensive, concise, culturally appropriate handouts for individuals and FAQ documents to assist with counseling and SMART goal setting are important resources necessary to address these challenges.

The guideline presents a flowchart of its key action statements in Figure 2. The flowchart furthers comprehension of the guideline’s logic, the sequence of action statements, and the interrelationships among key recommendations and options for managing non-pregnant adults with T2D, prediabetes, or a history of GDM. It serves as an accessible reference guide to facilitate the implementation of the guideline’s recommendations.

Research Needs

• 1. More research is needed into different ways to advocate therapeutic lifestyle interventions tailored to individual demographics (i.e., age, sex, race/ethnicity, region specific etc.,), especially in regard to people with GDM in whom advocating methods may differ significantly compared with non-pregnant population.

• 2. How can multiple electronic health records/artificial intelligence be harnessed for assessing a person’s baseline lifestyle behaviors through standardized, validated assessment tools?

• 3. In terms of establishing priorities for lifestyle changes, should people work on multiple behavior changes simultaneously, or should they focus on adopting one S.M.A.R.T. goal addressing one lifestyle pillar at a time?

• 4. How would a person’s sociodemographic determinants of health be addressed appropriately when prescribing culturally tailored physical activity using a FITT framework?

• 5. How does the timing (morning or later during the day) of exercise, and particularly regarding before or after meal intake, impact glycemic outcomes of people with prediabetes, T2D, or GDM?

• 6. What is the role of adequate physical activity in improving mental health and reducing anxiety/depression symptoms in people with prediabetes, T2D, or GDM?

• 7. How does HIIT impact the outcome of achieving T2D remission, preventing the progression of micro- and macro-vascular complications in people with T2D?

• 8. What is the optimal type and intensity of physical activity in people with GDM (and in particular regard to each trimester)?

• 9. Do “move alerts” from fitness trackers help decrease sedentary time in people with prediabetes, T2D, or GDM?

• 10. How does improved sleep health in a person with prediabetes, T2D, or GDM translate into better adherence to nutrition therapy or diabetes self-management?

• 11. What is the data on harnessing various type of consumer sleep technology (wearable sleep trackers) in people with prediabetes, T2D, or GDM?

• 12. How do different sleep chronotypes affect the risk and outcomes of prediabetes, T2D, or GDM, and how can these be used for creating personalized sleep plans?

• 13. How can nutrition therapy plan be best tailored to avoid or manage microvascular complications of T2D, especially diabetic kidney disease with which there may be specific parameters regarding protein source (plant vs animal), protein quantity (recommended daily intake), total daily sodium intake etc.?

• 14. How do medically tailored meals, or produce, prescriptions (Food as Medicine) help improve health outcomes for people with prediabetes, T2D, or GDM, especially the outcome of T2D remission?

• 15. What is the evidence for the role of intermittent fasting and eating based on circadian clock, for T2D remission and for health outcomes in people with prediabetes, T2D, or GDM?

• 16. How does social media affect the social connections, relationship satisfaction, glycemic and health outcomes of people with prediabetes, T2D, or GDM?

• 17. How does a person’s social connections and relationship framework affect their chances of achieving and maintaining T2D remission?

• 18. How can health systems and payers encourage systematic adoption of shared medical appointments widely to improve glycemic outcomes and reduce isolation among people with prediabetes, T2D, or GDM?

• 19. What tools can electronic health records utilize to identify people facing social isolation and experiencing loneliness?

• 20. What is the role of mindfulness-based mobile or digital apps for stress management and improved mental health outcomes in people with prediabetes, T2D, or GDM?

• 21. How can clinicians best address culturally sensitive factors such as stigma around mental illness in people with prediabetes, T2D, or GDM?

• 22. Is use of recreational drugs like opioids, cannabis or cocaine causally associated with worse outcomes in people with prediabetes, T2D, or GDM (particularly progression of prediabetes to T2D)?

• 23. Is the use of e-cigarettes (vaping) causally associated with worse outcomes in people with prediabetes, T2D, or GDM (particularly progression of prediabetes to T2D)?

• 24. Is the use of excessive alcohol causally associated with development/progression of microvascular complications in people with T2D (particularly neuropathy)?

• 25. What is the role of the use of modalities like coaching, CBT, etc., for sustaining long-term T2D remission (preventing relapse)?

• 26. Can electronic health record tools or artificial intelligence be leveraged to improve continuity of care and person engagement (particularly for postpartum mothers with history of GDM who are at higher risk of being lost to follow-up)?

• 27. How can systematic pharmacological deprescription be best tailored/ individualized in persons doing well with therapeutic lifestyle changes?

• 28. What are the most effective designs of peer and family support interventions and how they can be optimized to improve reliability to achieve outcomes?

• 29. How can we identify best practices among the wide variety of one-on-one, family and group interventions?

• 30. What are the most effective combinations of professional support among all multidisciplinary professionals trained to provide lifestyle therapy for preventing, treating and remitting T2D?

• 31. What would be the ideal clinical measures to study the impact of support interventions in achieving measure of the impact of support interventions in achieving short- and long-term remission of diabetes as opposed to just disease management?

• 32. What would be the optimal session frequency, intervention duration, modality, and mechanisms of stress management and psychological interventions, for preventing, remitting, optimally treating T2D?

• 33. How can we identify qualitative and quantitative research to explore the person’s experience in the context of lifestyle interventions and deprescribing, to confirm the limited previous work on a person’s priorities, challenges, and motivations?

• 34. How can we identify RCTs with intensive lifestyle interventions for T2D, to prospectively track the changing needs for medication and capture how adjustments are safely made?

ORCID iDs

Richard M. Rosenfeld https://orcid.org/0000-0002-3557-3795

Micaela C. Karlsen https://orcid.org/0000-0002-9365-151X

Abd Moain Abu Dabrh https://orcid.org/0000-0002-2481-483X

Jonathan P. Bonnet https://orcid.org/0000-0002-1917-0048

Beth Frates https://orcid.org/0000-0002-1156-7745

Elizabeth A. Joy https://orcid.org/0000-0002-4473-1038

Kara L. Staffier https://orcid.org/0000-0003-0998-1178

Mahima Gulati https://orcid.org/0009-0004-6726-4163