Blue Circle Health: A Novel Patient-Centered Model of Health Care Delivery for Low-Income Patients With Type 1 Diabetes

Abstract

Analog insulins, insulin pumps, and continuous glucose monitors (CGM) have revolutionized type 1 diabetes (T1D) treatment over the last 50 years. Nevertheless, less than 20% of patients in the United States reach guideline-based HbA1c targets. The dysfunctional delivery of U.S. health care has further worsened glycemic outcomes among structurally disadvantaged groups such as non-Hispanic Black and low-income populations. Administrative complexities resulting from mixed insurance coverage and delivery systems, incongruity between effective policies and reimbursement, structural racism, and implicit biases have led to high diabetes care-related costs, provider scarcity and burnout, and patient diabetes distress. The Extension for Community Healthcare Outcomes (ECHO) Diabetes tele-education outreach model was created to increase self-efficacy among primary care providers through a combination of weekly didactic sessions led by a team of diabetes experts and access to community-based peer coaches. As an evolution of ECHO Diabetes, Blue Circle Health has been established as a philanthropically funded health care delivery system, using a whole-person, individualized approach to T1D care for adults living in underserved communities. The program will provide direct-to-patient telehealth services, including diabetes education, management, and related psychological care regardless of ability to pay. Community-based diabetes support coaches will serve as the primary point of contact, or guide on the “Blue Circle Health Member Journey.” Access to needed insulins, supplies, and CGMs will be provided at no cost to the individual. Through a continuous learning and improvement model, a person-centered, equitable, accessible, and effective health care delivery model will be built for people living with T1D.

The U. S. Health Care Delivery System Has Failed Patients With Type 1 Diabetes

Thirty years ago, type 1 diabetes (T1D) care was transformed when the Diabetes Control and Complications Trial (DCCT) established that intensive blood glucose control, with an average HbA1c of 7% in the treatment group, significantly reduced disease-related complications. ¹ However, in the intervening years, diabetes care providers in the United States have faced a maddening paradox: although innovation has revolutionized treatment approaches and possibilities, only about 20% of individuals with T1D reach the American Diabetes Association (ADA) HbA1c goal of <7%. Indeed, the average HbA1c for adolescents and young adults is similar to that of the DCCT control group and has worsened in recent years. ² HbA1c in childhood and young adulthood is markedly lower in other developed countries with similar gross domestic product (GDP) per capita and half of U.S. health care expenditure per capita.^3,4

While transatlantic HbA1c gaps are prominent, inequities within U.S. populations are even more pronounced, predominantly when comparing non-Hispanic (NH) Black and NH White groups and individuals with the highest and lowest socioeconomic status (SES).^5,6 An HbA1c difference of 1.3% exists between the highest and lowest SES quintiles in the U.S.-based Type 1 Diabetes Exchange (T1DX) versus a 0.3% difference within the German Diabetes Prospective Follow-up (DPV) registry. ⁶ HbA1c gaps of 1% to 2% exist between U.S. NH Black and NH White groups; these persist even when controlling for SES and technology use. ⁵ Despite increased awareness of racism and income-based disparities in the U.S. health care system over time, inequities have remained fixed.^5,6

Flaws Within the U. S. Health Care Delivery System Have Led to Poor T1D Outcomes

T1D Patients Bear the Burden of Ballooning Health Care Costs in the United States

The high costs of diabetes-related medications and devices in the United States, not present in other developed health care systems, lead to reduced capacity to adequately manage diabetes.^7-13 The average annual medical expenditure for a patient with diabetes is $16,750: 2.3 times higher than that of someone without diabetes. ⁹ Medication and device-related expenses account for 38% of T1D-related out-of-pocket costs; in a recent survey of U.S. adults, 80% had taken out an average of $9k in credit card debt to cover the cost of insulin.^10,11 One in 4 patients at the Yale Diabetes Center in 2017 reported rationing their insulin due to cost; it is the most significant barrier to diabetes management in 24% of T1D patients.^12,13

Barriers to care are erected by insurance companies to maximize profit margins and to the detriment of T1D patients. These include prior authorizations with non-evidence-based prerequisites to receive insulin pumps and continuous glucose monitors (CGMs),^14-18 nonmedical switching of necessary medications,^19,20 and a convoluted system of covered pharmacy and durable medical equipment (DME) benefits that further raise health care costs by increasing administrative burden.^21-23 The chaotic system of covered health care benefits in the United States further exacerbates disparities, as only patients with the time, knowledge, and resources to navigate these complexities are likely to receive the newest technologies and treatments. These same issues may lead clinicians to gatekeep diabetes therapies. Provider-level factors, including providers declining to prescribe diabetes technology, were the largest barrier to insulin pump and CGM use in underserved T1D populations in several recent studies, even though these technologies can lead to a significant reduction in HbA1c.^24-27

The U. S. Health Care System Does Not Place T1D Patients at its Center

Within current fee-for-service models, impactful interventions that improve the lives of T1D patients are not appropriately incentivized or reimbursed (Figure 1). More frequent diabetes care leads to better health outcomes—the DCCT achieved tight glucose control with telephone care in addition to monthly clinic visits. ¹ However, there is an alarming U.S. workforce shortage of both pediatric and adult endocrinologists, especially within rural areas, due to poor clinician return on investment with additional time spent in training and lower eventual compensation when compared to procedural fields.^29-31 This has resulted in less access to diabetes specialists; many patients have a more-than-30-minute drive to the nearest clinic and clinicians have limited ability to schedule frequent follow-up visits. ³¹

Figure 1.

Barriers to effective type 1 diabetes (T1D) care within the U. S. health care system and downstream effects. Adapted framework based on the Social-Ecological Model of Health by Krug et al. ²⁸

Abbreviation: DSMES, diabetes self-management education and support.

Innovative solutions to these problems are also not well compensated by fee-for-service models. Current diabetes technologies including CGM and automated insulin delivery (AID) devices allow patients to share nearly-real-time blood glucose data with the diabetes care team for more frequent dosage adjustments in between visits. Reviewing blood glucoses and adjusting insulin doses between visits has been associated with a 0.44% to 0.75% reduction in HbA1c. ³² However, poor reimbursement for this service when provided outside of a traditional clinic appointment has required clinicians to use unbilled time to provide this type of care and limited broad implementation.

As COVID-19 pandemic measures lift, continued access to telehealth for people with T1D is also uncertain. During the height of the pandemic, telemedicine was widely adopted by endocrinology practices and granted reimbursement parity with in-person clinic visits.^33-37 Diabetes care is particularly well-suited to a telemedicine model, with feasible remote access to patient data and care centered around diabetes-related problem solving and behavioral coaching. ³⁷ The majority of T1D patients report using telemedicine for diabetes care over the years of the pandemic.^35,36 However, as emergency orders lift, reimbursement policies have varied among insurance plans and across state lines, creating undue administrative burden and making routine use of telemedicine more difficult.^38,39

Diabetes self-management education and support (DSMES) is another essential diabetes clinical service burdened by a shortage of providers and poor reimbursement policies and administrative practices. ⁴⁰ It is critical that people with T1D are empowered to implement and sustain self-management behaviors and strategies to maintain quality of life in the 99% of the time that they are not in a diabetes office. People with diabetes (PWD) should, at a minimum, receive DSMES at diagnosis, annually, when complications occur, and during transitions in care. When integrated with a diabetes management program, DSMES reduces HbA1c by at least 0.6%, improves quality of life, and reduces hospitalizations and health care costs. ⁴¹ Unfortunately, it is only used by 6.8% of privately insured PWD, and there is only one Certified Diabetes Care and Education Specialist (CDCES) for every 1500 patients.^40,42 This shortage, along with inconsistent insurance coverage and low reimbursement, requirement for physician referral, significant patient co-pays, as well as a lack of patient awareness and understanding of the service all limit access. Evidence-based and resourceful solutions to these problems, including telehealth, telephone, text message, and mobile phone application-based delivery of DSMES, are again poorly incentivized and reimbursed by current fee-for-service systems.^40-42

Life with T1D requires constant monitoring of blood glucoses and titration of potentially dangerous medications atop a background of societal diabetes stigma and a cumbersome, costly health care system. Over a third of U.S. adolescents and adults with T1D have moderate to severe diabetes distress, which denotes an emotional state of stress, guilt, or denial resulting from living with diabetes-related burdens and concerns.^43-45 Higher rates of diabetes distress in NHB populations account for part of the Black-White glycemic disparity in young adults with T1D. ⁴⁶ The prevalence of depression among adolescents with T1D is 2 to 3 times that of the general population and is associated with having an above-target HbA1c and a higher risk for diabetic ketoacidosis (DKA). ⁴⁷ The detailed monitoring of carbohydrates, meal planning, and utilization of food as medicine inherent to T1D management leads to increased risk for disordered eating and makes this issue more difficult to detect. ⁴⁵

Confronting previously mentioned issues—improving access to diabetes medications and supplies, specialists, and education—would go far toward addressing causes of diabetes distress. ⁴⁸ Peer support in the form of T1D group meetings or mentorship programs increases diabetes-specific social capital, reduces diabetes distress, and improves well-being, empowerment, and hope for the future.^49-52 However, these types of programs are largely reliant on grant funding and, though impactful, are often dissolved after the manuscripts demonstrating their efficacy are published.

Appropriately addressing mental well-being is of vital importance in treating the whole person with T1D. Specialized psychological care can address diabetes distress, anxiety, depression, disordered eating, and other needs unique to this population. ⁴⁵ Interventions to expand emotional regulation, problem solving, mindful self-compassion, and resilience reduce diabetes distress and can improve emotional well-being.^53,54 Psychosocial care providers should ideally be embedded within T1D clinics—when outside referrals are placed, only 50% schedule an appointment, and fewer remain involved over time. However, there is a shortage of trained mental health professionals knowledgeable in the unique issues related to living with diabetes, and billing for services is complex and variably reimbursed among states and insurance providers. ⁵⁵

ECHO Diabetes: A Model to Address Several Important Barriers in T1D Care

The Extension for Community Healthcare Outcomes (ECHO) model reduces health care disparities in a broad range of long-term diseases by disseminating subspecialty knowledge to providers via tele-education sessions. Starting in 2017, ECHO Diabetes, based in California and Florida, has addressed multilevel barriers to effective diabetes health care through this tele-education outreach model (Figure 2).^56,57 The program identified high-need catchment areas with low endocrinology provider density and high health risk/poverty areas using the Neighborhood Deprivation Index and provider geocoding. ⁵⁸ Primary care providers (PCPs) from the Federally Qualified Health Centers (FQHCs) in these areas were also targeted for recruitment as “spokes” to receive weekly tele-education sessions from expert T1D specialty “hubs” (Stanford University and the University of Florida), real-time support for complex T1D medical decision-making, access to diabetes support coaches (DSCs), access to CGM as donations allowed, and access to an online repository of diabetes care resources (Figure 3). In the pilot program, 23 spoke sites enrolled with 104 clinics serving more than 1900 patients with T1D. ⁵⁷

Figure 2.

Social ecological model of barriers to effective T1D management in under-resourced communities and Project ECHO Diabetes intervention, adapted with changes and permission from Walker.^24,28

Abbreviations: CGM, continuous glucose monitors; ECHO, Extension for Community Healthcare Outcomes; PCPs, primary care providers; TID, type 1 diabetes.

Figure 3.

Project ECHO Diabetes structure. Reprinted with permission from Walker. ⁵⁷

Abbreviation: ECHO, Extension for Community Healthcare Outcomes.

Data from initial needs assessments with n = 123 PCPs in California and Florida indicated critical knowledge gaps in diabetes technologies including CGM and insulin pump therapy, guiding curricular development for the weekly tele-education ECHO clinics. In a 6-month pilot period, 27 CME-credited sessions were conducted via Zoom (Zoom Video Communications, San Jose, California, USA) and included a 20- to 30-minute talk on diabetes care followed by de-identified complex case presentations by the participating primary care spokes.^57,59 PCPs had significant improvements in knowledge and confidence before and 6 months after the intervention, with 95% recommending the program and 63% reporting that what they learned in tele-ECHO clinics led them to change their T1D practices, especially regarding diabetes technology. ⁵⁷

In the initial pilot of the ECHO T1D program, DSCs were hired to work with participating spokes in Florida and California. Combing the role of a community health worker (CHW) and a peer mentor, DSCs are people living with diabetes in the areas that they serve, providing invaluable expert knowledge of both diabetes and community resources. ⁵² They attended weekly tele-education sessions and hub team meetings, met monthly with clinical health psychologists to address psychosocial challenges of their role, and received multiple diabetes-specific and CHW-specific trainings as detailed elsewhere. ⁵² They organized social events for T1D communities and created local T1D resource guides in Spanish, English, and Creole including information on insulin assistance, food insecurity resources, and T1D support groups. They worked one-on-one with 124 T1D patients who opted in to receive intensive, weekly outreach via text, phone calls and in-person visits (with 80% of encounters by phone or text). They facilitated 1400 outreach interactions over a 6-month period, focusing especially on patient engagement with diabetes technologies, peers, and the health care team as well as addressing social determinants of health. ⁵⁷ Adults participating in intensive outreach services for 6 months had improvements in HbA1c of 1.2% from baseline. ⁵² In qualitative interviews, DSCs reported financial difficulties, unaddressed mental health problems, and low health literacy as three interconnected and important problems facing PWD in underserved communities. Diabetes support coaches’ major self-reported strengths within the health care team lied in their first-hand knowledge of life with T1D and the unique challenges facing their patient population. ⁵²

Blue Circle Health Will Build Upon ECHO Diabetes to Redefine the T1D Care Model

While ECHO Diabetes continues to address important barriers to optimal T1D patient care, including access to diabetes specialists, peer support, diabetes technology, and resources to improve social determinants of health, this primarily tele-educational and peer-support intervention does not profess to solve some of health care’s biggest structural problems. In the fall of 2021, the Helmsley Charitable Trust, a non-profit foundation and sponsor of many T1D research and care initiatives, held a meeting of T1D experts that aimed to answer the question:

If we could create a healthcare delivery system for people with T1D- unconstrained by tradition or reimbursement concerns- what would it look like? ⁶⁰

The resulting ongoing discussion inspired the creation of Blue Circle Health (BCH); a philanthropically funded health care delivery system centered around people with T1D living in underserved communities. Blue Circle Health was founded upon the following set of guiding principles:

• We will focus on people with lesser means and fewer resources.

• We will find ways to ensure people with T1D have access to insulin, supplies, technology, diabetes education, management, treatment, and related psychological care and support regardless of their ability to pay.

• We will not assume to know the needs of the people we serve. We will learn by listening.

• We recognize that trusted relationships are the building blocks of improved outcomes.

• We will take a whole-person, individualized approach to care.

• We will look to capitalize on existing services and resources when available.

• We will be a learning organization and will rely on data and continuous improvement to make decisions.

• We will not let people fall through the cracks—we will track and support their journey throughout our involvement.

• We will give a voice to the people who never get a seat at the table designing diabetes care, medications, and devices.

• We will serve as a model of how T1D care can and should be delivered to as many people as possible.

• We will include the loved ones and caregivers of people with T1D, knowing how this disease involves more than the patient alone.

• We never blame, judge, or shame a person with T1D; our approach will involve empathy, understanding, and respect. ⁶⁰

Building upon Project ECHO Diabetes’ successes, BCH’s delivery model will partner with FQHCs to take a “whole-person” approach to diabetes care (Figure 4). ⁶¹ Patient care will center upon community-based trained DSCs as the primary accessible point of contact within the system, or the guide on the “Blue Circle Health Member Journey.” ⁶⁰ Beginning in September 2022, BCH launched by collaborating with 13 Florida-based FQHCs who participated in ECHO Diabetes to serve adults with T1D receiving care in these centers. They will use DSCs who also participated in ECHO Diabetes to serve as advocates and liaisons for services within their community as well as points of contact for group sessions and social events, much as in their previous roles (Figure 5).

Figure 4.

A path toward health equity and improved type 1 diabetes outcomes through the ECHO Diabetes and Blue Circle Health initiatives.^57,61

Abbreviation: ECHO, Extension for Community Healthcare Outcomes.

Figure 5.

Blue Circle Health timeline of offerings and progression from project ECHO diabetes.

Abbreviations: CGM, continuous glucose monitors; ECHO, Extension for Community Healthcare Outcomes; FQHC, federally qualified health center; TID, type 1 diabetes.

In the second phase of the project, expected to launch in early 2023, a multidisciplinary health care team including BCH-funded nurses, advanced practice nurses, registered dieticians, CDCES, insurance navigators, behavioral health specialists, social workers, and endocrinologists with expertise in T1D will begin to provide direct to patient medical services. The care model will capitalize upon existing resources and will use insurance navigation when feasible but will ensure that T1D-related medications and supplies are available at no cost to the patients. Ultimately, BCH will work where possible to connect uninsured and underinsured patients with necessary external resources to adequately cover diabetes-related costs. Safeguards will be implemented to prevent loss to follow-up and lapses in care and clear communication with PCPs will be emphasized. Information will be exchanged with PCPs via application programming interfaces (APIs) to communicate electronic medical record data via Health Level 7 (HL7) standards, and encrypted emails will be sent to providers as preferred.

Diabetes self-management education and support, nutritional and medication counseling, behavioral health, and diabetes clinical care will all be provided with a direct-to-patient telehealth model to address access and transportation issues. Continuous glucose monitor, HbA1c, and survey data including information regarding mental health and diabetes distress, technology use, and patient satisfaction will be collected at baseline and at least every 6 months. Remote monitoring systems will be developed that can integrate CGM data feeds and predictive models to anticipate dangerous situations (rising HbA1c, DKA), improving outcomes in between visits.^60,62 By improving access to holistic diabetes care, we expect to see individual benefits in diabetes-related mental and physical health outcomes.

Future Challenges and Opportunities

Importantly, BCH will be able to learn from its successes and failures and nimbly invest in innovative solutions by prioritizing continuous learning and improvement. Untethered by the usual constraints of a for-profit health care delivery system or overly bureaucratic not-for-profit systems, BCH has an infrastructure designed to focus on the patient. Blue Circle Health will gather information related to social determinants of health, mental health, and disease progression and use that data to facilitate decision support, intervene with appropriate services, and improve operations. While the organization is not specifically designed as a research endeavor, consent for ethical and scientifically valid data reuse and recontact for future research will be obtained upon enrollment. ⁶⁰

The current model uses DSCs embedded in underserved communities to maintain connection and trust with patients while relying on telemedicine-based delivery of most formal medical, psychological, and social work services. The exclusive delivery of some care via telemedicine may prove challenging for patients who lack the resources to effectively use these services and those with low digital health literacy. Diabetes support coaches and other support staff will play a key role in ensuring patient access to care is maintained. In addition, partnerships with FQHCs will help to ensure continuity of care and coordination across primary and specialty care. A multifaceted approach to information exchange will be needed across organizations and providers. Blue Circle Health will connect with local health information exchanges to receive notification of patient hospital admissions and discharges. Data use agreements with FQHCs will accommodate exchange of information for eligible patient identification, clinical care, and quality improvement. Along with social determinants of health, BCH will track data related to diabetes services and outcomes for NHB and other minority populations to optimize health equity for patients being served by the organization.

Blue Circle Health’s network of ancillary staff including insurance navigators and social workers will seek to minimize the administrative complexities of working both inside of and external to the current U.S. health care system. Decisions on if or how BCH can or should interact formally with traditional payors (e.g. Medicaid, Medicare, Commercial) will require ongoing review of the associated administrative burden and return on investment.

As the program expands, scaling services to meet the demands of a larger population, along with continuing to build community relationships in all served areas may prove challenging. Nevertheless, a clear goal and expectation of the organization is to serve as many patients as possible. To accomplish this, the tempo and duration of interaction with BCH care providers will be based on pursuit of individualized patient goals as they progress through the program.

Ultimately, BCH’s sustainability outside of philanthropic funding within the current fee-for-service model of care will present a substantial challenge. Many people served within the program will have greater need for services but lower reimbursement rates for care via Medicaid or through self-pay. Even within a value-based model of care, the bureaucracy involved in policy change would take significant investments of time, resources, and the buy-in of numerous stakeholders to come to fruition. A model of continuous philanthropic funding, such as the St. Jude Research Hospital operating model in which the majority of funding comes from charitable donations, may be a more feasible future model to consider. ⁶³ Blue Circle Health will invest in fundraising efforts along with presentation of findings and results of the program to key stakeholders.

People with T1D deserve a health care system that is person-centered, affordable, equitable, accessible, effective, and addresses the complex needs of daily life with T1D. Blue Circle Health seeks to democratize access to diabetes care by creating a novel, philanthropy backed, patient-centered health care delivery system for underserved and low-income people with T1D.