Abstract
Quality Improvement Success Stories are published by the American Diabetes Association in collaboration with the American College of Physicians and the National Diabetes Education Program. This series is intended to highlight best practices and strategies from programs and clinics that have successfully improved the quality of care for people with diabetes or related conditions. Each article in the series is reviewed and follows a standard format developed by the editors of Clinical Diabetes. The following article describes a quality improvement project to improve outcomes by increasing the prescribing rates of GLP-1 receptor agonists in pediatric patients with type 2 diabetes in the pediatric endocrinology clinics of a Seattle, WA–based health care system.
Describe your practice setting and location.
This pediatric endocrinology practice is staffed by endocrinologists and advanced practice practitioners within a tertiary care, stand-alone children’s hospital serving an ethnically diverse population in the states of Washington, Montana, Idaho, and Alaska. Clinic locations include both the main campus in Seattle, WA, and regional clinic sites in the state of Washington.
Describe the specific quality gap addressed through the initiative.
Type 2 diabetes in youth is becoming increasingly prevalent and is recognized as an aggressive and unique disease, particularly when compared with adult-onset type 2 diabetes. The American Diabetes Association (ADA) and the International Society for Pediatric and Adolescent Diabetes recommend a target A1C level of <7% for children and adolescents with type 2 diabetes and a more stringent target of <6.5% if attainable without significant hypoglycemia or adverse effects (1,2). According to the TODAY (Type 2 Diabetes in Adolescents and Youth) study, hypoglycemia is uncommon in this population even when teenagers with type 2 diabetes are receiving insulin therapy (3,4). This finding suggests that an A1C target of <6.5% is appropriate (1). Additionally, pediatric type 2 diabetes is associated with a high prevalence of complications, which manifest as early as adolescence and young adulthood and are associated with higher A1C levels (5). At a mean diabetes duration of 7.0 years, 72% of youth and young adults with type 2 diabetes had at least one early diabetes-related complication or comorbidity compared with 32% of youth with type 1 diabetes (5). This recent evidence demonstrates that youth with type 2 diabetes should pursue aggressive therapy aiming to achieve a lower A1C target to prevent diabetes-related complications.
Before 2019, the standard of care treatments for youth <18 years of age with type 2 diabetes were insulin (basal and prandial) and metformin. With these therapeutic options, from June 2018 to June 2019, 34% of our pediatric patients with type 2 diabetes were achieving an A1C <6.5%. On 17 June 2019, the U.S. Food and Drug Administration (FDA) approved the first glucagon-like peptide 1 (GLP-1) receptor agonist for use in children ≥12 years of age with type 2 diabetes. GLP-1 receptor agonist therapy has been shown to reduce A1C by 0.64% and lead to weight loss (−2.3 kg) in youth after 26 weeks of therapy (6) and to improve cardiovascular and renal health in adults (7,8). With this new medication available to improve A1C and outcomes in youth with type 2 diabetes, the ADA updated its Standards of Care in Diabetes to include the addition of a GLP-1 receptor agonist if glycemic targets are not met with metformin and lifestyle changes (1). This quality improvement (QI) project was undertaken to improve adherence to the new standards of care by increasing the use of GLP-1 receptor agonist therapy in our youth with type 2 diabetes and thereby improve treatment outcomes.
How did you identify this quality gap? In other words, where did you get your baseline data?
Given that GLP-1 receptor agonists were not previously approved for use in youth with type 2 diabetes, we hypothesized that prescribing rates would be low in this population before 2019. Retrospective chart review of GLP-1 receptor agonist therapy in youth <18 years of age with type 2 diabetes who were seen in our practice confirmed this gap and affirmed that, even several months after FDA approval, GLP-1 receptor agonist prescribing rates remained low. Additionally, the proportion of youth with type 2 diabetes with an A1C >6.5% remained high.
Summarize the initial data for your practice (before the improvement initiative).
Monthly rates of prescribing GLP-1 receptor agonists to youth with type 2 diabetes ranged from 1.6 to 11.9% from January 2021 to January 2022. Of the 312 youth with type 2 diabetes in our practice, 114 (37%) attained the target A1C of <6.5%. The percentage of youth with A1C <6.5% was 30% among those taking a GLP-1 receptor agonist and 38% among those not taking a GLP-1 receptor agonist between January and the end of December 2021 (Table 1).
Table 1.
GLP-1 Receptor Agonist Prescriptions Among Pediatric Patients With Type 2 Diabetes in 2021 Based on Glycemic Control (N = 312)
| Patient Group | Prescribed a GLP-1 Receptor Agonist |
Not Prescribed a GLP-1 Receptor Agonist |
Total | |||
|---|---|---|---|---|---|---|
| n | % | n | % | n | % | |
| A1C <6.5% | 17 | 30 | 97 | 38 | 114 | 37 |
| A1C ≥6.5% | 40 | 70 | 158 | 62 | 198 | 63 |
| Total | 57 | 100 | 255 | 100 | 312 | 100 |
What was the time frame from initiation of QI initiative to its completion?
We measured rates of prescribing GLP-1 receptor agonists (liraglutide and exenatide) 1 year before initiating this QI project in January 2022, and for 1 year after the start of the project (from 18 January 2022 to 18 January 2023).
Describe your core QI team. Who served as project leader, and why was this person selected? Who else served on the team?
Two physicians in our practice served as project leaders. We believed it was important to have them as champions given their years of experience in type 2 diabetes, knowledge of the practice culture, and ability to encourage the participation of other staff. Another physician served as a QI expert. Additionally, we had a clinical program manager to help track progress with GLP-1 receptor agonist utilization. Endocrinology nurses were involved in the intervention and provided feedback on ways to improve the initiation of GLP-1 receptor agonists in our youth with type 2 diabetes.
Describe the structural changes you made to your practice through this initiative.
A multidisciplinary team, including diabetes practitioners and nurses developed GLP-1 receptor agonist education sessions for the medical practitioners and the insulin-weaning protocol that allowed nurses to independently wean insulin doses for patients as a safety precaution to prevent hypoglycemia. This multidisciplinary team met quarterly to review patients and clinical practice updates. The QI team met with the entire endocrinology division once at the start of the initiative to review the insulin-weaning protocol.
Describe the most important changes you made to your process of care delivery.
We focused on improving practitioner and staff comfort with prescribing and knowledge about GLP-1 receptor agonists. In January 2022, we provided an education series on GLP-1 receptor agonists and related new ADA recommendations for dietitians, medical providers, and advanced practice practitioners. This program included a presentation and an information handout about the GLP-1 receptor agonist liraglutide (Supplementary Material). Our analysis focused on liraglutide and exenatide because these agents were FDA-approved during the time frame of the QI project; however, because a majority of patients were prescribed liraglutide, we only developed educational materials on liraglutide.
A formal clinic protocol for GLP-1 receptor agonist initiation and subsequent insulin weaning was developed with nursing involvement to increase comfort with and standardization of this process. Once patients were prescribed a GLP-1 receptor agonist, a nurse trained patients and their families in the clinic on how to administer the therapy and advised them about common side effects. The nurse was then tasked with following up with patients weekly for insulin dose adjustments based on the insulin-weaning algorithm (Supplementary Material). Because of nursing staff shortages, some patients were advised to contact the clinic weekly with their blood glucose logs through electronic medical record patient portal messaging or by telephone. An endocrinology nurse would then follow up with patients and adjust insulin dosing based on the algorithm. If patients had severe hypoglycemia or hyperglycemia or were going to discontinue insulin therapy, nurses contacted their primary endocrinologist for guidance.
Direct nursing follow-up ended after patients reached their goal GLP-1 receptor agonist dose and/or discontinued insulin therapy. Patients were encouraged to contact the clinic with any questions or concerns even after these goals were met. This partnership with nursing staff helped to expedite GLP-1 receptor agonist initiation and dose titration and insulin weaning. This protocol helped to increase patient engagement and GLP-1 receptor agonist uptake.
Summarize your final outcome data (at the end of the improvement initiative) and how they compared to your baseline data.
The baseline GLP-1 receptor agonist prescribing rate was 1.2% in January 2021. The monthly prescribing rate then increased to 7.4% by January 2022. After the interventions described above, the average monthly prescribing rate increased to 12.0% in 2022 (Figure 1). The percentage of patients on GLP-1 receptor agonist therapy decreased in July and August 2022. In the clinic, we noticed that the diabetes nurses had limited capacity to work on prior authorizations for GLP-1 receptor agonists. We contacted a mail order pharmacy to outsource the prior authorization work. There was a trend of higher prescribing rates after we started using this mail order pharmacy service.
Figure 1.
Percentage of patients prescribed GLP-1 receptor agonist therapy from January 2021 through January 2023.
The mean A1C for all patients with type 2 diabetes in 2022 was similar to that of all patients with type 2 diabetes in 2021. In both 2021 and 2022, mean A1C levels were higher in the group receiving a GLP-1 receptor agonist than in those not on GLP-1 receptor agonist therapy (Table 2). Although patients on a GLP-1 receptor agonist did not have a lower mean A1C, data reflect that those with higher A1C levels were more likely to be selected to initiate GLP-1 receptor agonist therapy in an effort to meet glycemic targets. Of note, of the 40 patients on GLP-1 receptor agonist therapy who had a repeat A1C completed in 2022, 18 (45%) had a decrease in A1C, suggesting that initiation of GLP-1 receptor agonist therapy may have contributed to improved glycemic management.
Table 2.
A1C Values in Youth With Type 2 Diabetes With and Without GLP-1 Receptor Agonist Therapy in 2021 and 2022
| 2021 | 2022 | |||||
|---|---|---|---|---|---|---|
| All | Prescribed a GLP-1 Receptor Agonist | Not Prescribed a GLP-1 Receptor Agonist | All | Prescribed a GLP-1 Receptor Agonist | Not Prescribed a GLP-1 Receptor Agonist | |
| Patients, n (%) | 312 (100) | 57 (18.3) | 255 (81.7) | 310 (100) | 97 (31.3) | 213 (68.7) |
| A1C, %, mean ± SD | 7.8 ± 2.4 | 8.3 ± 2.4 | 7.7 ± 2.4 | 7.8 ± 2.6 | 8.6 ± 2.8 | 7.4 ± 2.4 |
For all patients with type 2 diabetes who were started on a GLP-1 receptor agonist (N = 90) after our QI initiative was implemented in early 2022, a majority (n = 68 [75.6%]) were taking subcutaneous insulin (long- acting basal and/or bolus insulin) at baseline. We followed patients for 1 year after a GLP-1 receptor agonist was prescribed and initiated and found that 12.2% (n = 11) were able to wean off their insulin regimen completely, and 17.8% (n = 16) remained off insulin (Table 3). Around 57% (n = 51) of patients did need to maintain insulin therapy, even after starting GLP-1 receptor agonist therapy.
Table 3.
Rate of Insulin Weaning 1 Year Post-Initiation of GLP-1 Receptor Agonist Therapy (N = 90)
| Insulin Status | n (%) |
|---|---|
| Completely weaned off of insulin | 11 (12.2) |
| Remained off of insulin therapy | 16 (17.8) |
| Remained on insulin therapy | 51 (56.7) |
| Unknown status (lost to follow-up) | 12 (13.3) |
Of the patients who were started on a GLP-1 receptor agonist during our QI intervention, we were able to assess the change in BMI 1 year after initiation of the GLP-1 receptor agonist in 75 patients (Table 4). Around 46.7% (n = 35) had a lower BMI 1 year post–GLP-1 receptor agonist initiation, with an average decrease in BMI of 1.52 ± 1.2 kg/m2, corresponding to a mean weight loss of ∼2.5 ± 4.8 kg. Those who gained weight while on GLP-1 receptor agonist therapy (n = 39, 52%) had an average BMI increase of 2.26 ± 2.0 kg/m2, corresponding to an average weight gain of ∼7.6 ± 6.9 kg. Among those who were able to be weaned off of insulin completely after starting a GLP-1 receptor agonist (14 of the 16 patients had complete anthropometric data), 50% (n = 7) lost weight, with an average BMI decrease of 1.72 ± 1.1 kg/m2, corresponding to a mean weight loss of 3.2 ± 5.5 kg. The remaining individuals who gained weight had an average increase in BMI of 2.9 ± 1.7 kg/m2, corresponding to a mean weight gain of 11 ± 6.4 kg. These data suggest that youth with type 2 diabetes, even while on GLP-1 receptor agonist therapy and off of insulin therapy, can still gain excess weight and underscore the notion that, although weight-promoting medications such as insulin can contribute to weight gain, obesity is complex and multifactorial.
Table 4.
BMI Changes Pre-Initiation and 1 Year Post-Initiation of GLP-1 Receptor Agonist Therapy
| Cohort | BMI Before GLP-1 Receptor Agonist Therapy, kg/m2 | BMI 1 Year After Starting GLP-1 Receptor Agonist Therapy, kg/m2 | Difference in BMI, kg/m2 |
|---|---|---|---|
| All youth on GLP-1 receptor agonist therapy (n = 75) Weight losers (n = 36) Weight gainers (n = 39) |
36.3 ± 8.8 37.2 ± 9.4 35.5 ± 8.2 |
36.8 ± 8.9 35.7 ± 9.5 37.8 ± 8.3 |
0.5 ± 2.5 −1.5 ± 1.2 2.3 ± 2.0 |
| Youth weaned off of insulin (n = 14) Weight losers (n = 7) Weight gainers (n = 7) |
36.1 ± 10.5 40.2 ± 12.3 31.9 ± 6.9 |
36.6 ± 10.0 38.5 ± 12.9 34.8 ± 6.3 |
0.6 ± 2.8 −1.7 ± 1.1 2.9 ± 1.7 |
Data are mean ± SD.
One limitation in our analysis was that we used a retrospective chart review. Patients may have been prescribed a GLP-1 receptor agonist, but we did not have a method to accurately determine whether their adherence to the medication was consistent or whether they were able to titrate up to the goal dose of the GLP-1 receptor agonist. Of note, some patients were lost to follow-up or were not able to be seen in person (i.e., were seen via telemedicine) for accurate anthropometric measurements. The number of youth with type 2 diabetes on a GLP-1 receptor agonist who were able to wean off of insulin completely was also small, thus making it difficult to draw conclusions.
What are your next steps?
Given the increasing prevalence of type 2 diabetes in youth, our type 2 diabetes multidisciplinary clinic serves as a model of how to best serve this growing population and optimize GLP-1 receptor agonist utilization within it. We plan to share this clinic’s formation and growth with other pediatric institutions. Additionally, we hope our inclusion of the insulin-weaning algorithm and liraglutide information sheet with this article (Supplementary Material) will allow other clinics and patients with type 2 diabetes to benefit from our project.
Future steps to increase GLP-1 receptor agonist prescription rates will include holding a yearly review of pharmacotherapy for type 2 diabetes for our medical practitioners and staff to ensure that all are aware of the indications for initiating GLP-1 receptor agonist therapy. With the advent of more effective GLP-1 receptor agonists, it is important to provide up-to-date education sessions and patient materials (specifically for the newer weekly GLP-1 receptor agonist semaglutide). We also aim to identify barriers that may prohibit youth with type 2 diabetes from accessing these medications, such as poor insurance coverage and low available supplies. We plan to implement patient surveys to assess adherence to GLP-1 receptor agonist medications to better understand whether patients who are prescribed these agents are taking them appropriately.
Healthy lifestyle intervention that leads to weight loss and maintenance of weight loss is a cornerstone of type 2 diabetes management. GLP-1 receptor agonists are also FDA-approved for weight loss management in youth. Thus, we plan to examine in greater depth the long-term effects of improving GLP-1 receptor agonist utilization on weight loss in youth with type 2 diabetes.
Finally, the use of GLP-1 receptor agonists can decrease insulin requirements in patients with diabetes. It is known that intensive insulin therapy promotes weight gain, which worsens insulin resistance and, subsequently, glycemic control (9). Future projects will focus on improving the insulin-weaning protocol and streamlining its implementation by nursing staff, who require better support to follow up with patients on GLP-1 receptor agonist therapy and assist with the protocol.
What lessons did you learn through your QI process that you would like to share with others?
Having a multidisciplinary QI team is important to be successful. Engaging our nursing staff as the frontline for many of the between-visit contacts for these patients was key to our success in initiating and maintaining GLP-1 receptor agonist therapy in these patients.
This article contains supplementary material online at https://doi.org/10.2337/figshare.28319726.
Acknowledgments
Acknowledgments
The authors acknowledge the Seattle Children’s Hospital endocrinology nursing team and especially Michael Myers, RN, for his assistance in implementing and revising the insulin-weaning protocol. They also acknowledge Dwight Barry for assistance in developing the figure and Noah Espinoza for assistance with electronic medical record data extraction.
Duality of Interest
No potential conflicts of interest relevant to this article were reported.
Author Contributions
A.H. and G.K. devised and implemented the QI initiative, analyzed the data, and wrote the manuscript. A.R. provided QI expertise and reviewed and edited the manuscript. Y.M. analyzed the data and reviewed the manuscript. G.K. is the guarantor of this work and, as such, had full access to all the data in the project and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Footnotes
This series is published by the American Diabetes Association in collaboration with the American College of Physicians, Inc., and the National Diabetes Education Program. The American College of Physicians and the American College of Physicians logos are trademarks or registered trademarks of the American College of Physicians, Inc., in the United States and shall not be used otherwise by any third party without the prior express written consent of the American College of Physicians, Inc. Likewise, products and materials that are not developed by or in partnership with the National Diabetes Education Program are prohibited from using the National Diabetes Education Program logo.
Supporting information
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