Peer Mentoring for Type 1 Diabetes

(Glu-COACH Trial)

Overseen By Robin Whittemore, PhD, APRN, FAAN

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Current CGM use, Pregnancy, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using a continuous glucose monitoring device for diabetes management.

What data supports the effectiveness of the treatment Enhanced standard-of-care (ESOC), Dexcom G6, Dexcom G6 Continuous Glucose Monitoring System, Glu-COACH, Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 CGM System for Type 1 Diabetes?

Research shows that using the Dexcom G6 Continuous Glucose Monitoring System can significantly lower HbA1c levels (a measure of blood sugar control) and improve quality of life for people with diabetes. Most users reported high satisfaction and ease of use, indicating that the system is effective and user-friendly. ^{1 2 3 4 5}

Is the Dexcom G6 Continuous Glucose Monitoring System safe for use in humans?

The Dexcom G6 Continuous Glucose Monitoring System has been used safely in various studies involving people with diabetes, including children and adults. It has shown high user satisfaction and ease of use, with improvements in blood sugar control and reduced concerns about low blood sugar. ^{1 2 3 4 6}

How is the Glu-COACH treatment for Type 1 Diabetes different from other treatments?

The Glu-COACH treatment, using the Dexcom G6 Continuous Glucose Monitoring System, is unique because it provides real-time glucose monitoring, which helps patients manage their blood sugar levels more effectively and can lead to improved quality of life and reduced diabetes-related stress. Unlike traditional methods, it offers features like alerts for high or low blood sugar and remote data sharing, which can enhance patient engagement and glycemic control. ^{1 2 3 7 8}

What is the purpose of this trial?

This is a study to develop and evaluate a peer mentoring intervention for Black and Latinx adolescents with type 1 diabetes to increase the initiation and maintenance of a continuous glucose monitoring (CGM) device. This device is a standard of care to improve diabetes management related to diet, exercise, and insulin. Use of CGM has been shown to improve health outcomes, but is not used by adolescents of color. Peer mentors may help improve usage.

Research Team

Robin Whittemore, PhD, APRN, FAAN

Principal Investigator

Yale School of Nursing

Stuart A Weinzimer, MD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for Black and Latinx adolescents with type 1 diabetes who may benefit from using a continuous glucose monitor (CGM) to manage their condition. The study aims to help those who have not started or are struggling to maintain the use of CGM.

Inclusion Criteria

I have not used a CGM for my Type 1 Diabetes for more than a week in the last three months.

Ability of participant to comprehend and communicate in written and spoken English, in order to complete surveys and participate in mentioning sessions and other interview (parents/caregivers do not need to have English fluency)

Access to personal cellphone or tablet to participate in remote video sessions with the peer mentor

Exclusion Criteria

Current or planned pregnancy

Participants with a prior severe skin reaction to CGM sensor or adhesive

Inability to comprehend or communicate in spoken/written English

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either enhanced standard-of-care (ESOC) or Glu-COACH intervention, which includes peer-mentoring support and access to a private social media group

6 months

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, 3 months, and 6 months

6 months

Assessments at baseline, 3 months, and 6 months

Treatment Details

Interventions

• Enhanced standard-of-care (ESOC)
• Glu-COACH

Trial Overview The Glu-COACH program, which involves peer mentoring, is being tested against enhanced standard-of-care (ESOC). The goal is to see if having a mentor can increase the adoption and consistent use of CGMs in these communities.

Participant Groups

Group I: Glu-COACH Experimental Treatment 2 Interventions

The experimental group will receive ESOC plus peer-mentoring support from a peer of the same cultural identity (Glu-COACH) and access to a private social media group for all Black and Latinx teens to improve the initiation and maintenance of CGM (Dexcom)

Group II: Enhanced standard-of-care (ESOC) Active Control 1 Intervention

This group will receive ESOC including additional training and support on CGM beyond routine clinical practice.

Enhanced standard-of-care (ESOC) is already approved in United States for the following indications:

Approved in United States as Dexcom G6 for:

• Management of diabetes in persons age 2 years and older

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

The Dexcom G6 continuous glucose monitoring (CGM) system demonstrated a mean absolute relative difference (MARD) of 7.7% in accuracy when compared to laboratory blood glucose measurements, indicating high reliability for monitoring glucose levels in children and adolescents with type 1 diabetes.

With 96.2% of estimated glucose values falling within 20% of the reference values, the G6 system's accuracy supports its potential to enhance glycemic control and encourage consistent use among young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System in Pediatric Participants With Type 1 Diabetes. Welsh, JB., Zhang, X., Puhr, SA., et al.[2020]

In a study of 248 patients with type 1 or type 2 diabetes, initiating continuous glucose monitoring (CGM) with the Dexcom G6 System led to a significant reduction in HbA1c levels from 8.2% to 7.1% over 3-5 months, indicating improved glycemic control.

Participants also reported decreased diabetes distress and hypoglycemic concerns, with high satisfaction rates (93%) and ease of use (73%) for the CGM system, suggesting positive psychosocial impacts alongside clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Change in Hemoglobin A1c and Quality of Life with Real-Time Continuous Glucose Monitoring Use by People with Insulin-Treated Diabetes in the Landmark Study. Gilbert, TR., Noar, A., Blalock, O., et al.[2022]

The Dexcom G4 Platinum with Software 505 algorithm (SW505) demonstrated significantly better accuracy and performance compared to the original G4 Platinum system (G4P) in youth with diabetes, with a mean absolute relative difference (MARD) of 10% for SW505 versus 17% for G4P when compared to reference measurements.

Both systems were found to be safe, with no serious adverse events reported, but the improved accuracy of SW505 has the potential to enhance glucose management and glycemic outcomes in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Accuracy of Continuous Glucose Monitoring Systems in Pediatric Patients with Diabetes Mellitus: Results from Two Studies. Laffel, L.[2018]

The Dexcom G6 real-time continuous glucose monitoring (RT-CGM) system significantly improves glycemic control in adults with type 1 diabetes, showing a projected HbA1c reduction of 1.0% compared to 0.4% with standard blood glucose monitoring (SMBG).

Despite higher lifetime costs associated with RT-CGM (CAD 35,353 more than SMBG), it provides substantial quality of life benefits and is considered cost-effective, with an incremental cost-effectiveness ratio of CAD 16,931 per quality-adjusted life year (QALY) gained.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Long-Term Cost-Effectiveness of the Dexcom G6 Continuous Glucose Monitor versus Self-Monitoring of Blood Glucose in People with Type 1 Diabetes in Canada. Roze, S., Isitt, JJ., Smith-Palmer, J., et al.[2022]

The enhanced algorithm for the Dexcom G6 Continuous Glucose Monitoring (CGM) System maintained high accuracy, with a 91.8% accuracy rate, while significantly reducing sensor errors.

The new algorithm led to a 59% decrease in total time spent in sensor error, improving data availability, which could enhance patient experience and integration with insulin delivery systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Modified CGM Algorithm Enhances Data Availability While Retaining iCGM Performance. Harvey Towers, RA., Zhang, X., Yousefi, R., et al.[2022]

In a study of 31,034 continuous glucose monitoring (CGM) users transitioning from the G5 to the G6 system, high rates of persistent use were observed, with 90% continuing to upload data in 2019 and 86.6% in 2020.

The G6 system demonstrated improved glycemic outcomes compared to the G5, including higher device utilization, reduced hypoglycemia, increased time in range (TIR), and a significant reduction in the need for calibrations, indicating a lower user burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustainable Use of a Real-Time Continuous Glucose Monitoring System from 2018 to 2020. van der Linden, J., Welsh, JB., Walker, TC.[2022]

The use of optional features in the G6 continuous glucose monitoring (CGM) system, such as alerts and remote data sharing, is associated with better glycemic outcomes, including increased time in range (TIR) for users.

Younger patients and those with type 1 diabetes are more likely to utilize certain features, indicating that demographics influence how effectively patients engage with CGM technology to manage their diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Evidence and Glycemic Improvement Using Dexcom G6 Features. Akturk, HK., Dowd, R., Shankar, K., et al.[2021]

Users of continuous glucose monitors (CGMs) reported significantly greater benefits and fewer burdens compared to nonusers, with mean scores indicating higher satisfaction (4.48 vs. 4.19 for benefits) and lower perceived burdens (1.69 vs. 2.35) among CGM users.

CGM users had better glycemic control, as indicated by lower average HbA1c levels (8.1% for users vs. 9.1% for nonusers), highlighting the efficacy of CGMs in managing type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived Burdens and Benefits Associated With Continuous Glucose Monitor Use in Type 1 Diabetes Across the Lifespan. Divan, V., Greenfield, M., Morley, CP., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Performance of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System in Pediatric Participants With Type 1 Diabetes. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Change in Hemoglobin A1c and Quality of Life with Real-Time Continuous Glucose Monitoring Use by People with Insulin-Treated Diabetes in the Landmark Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Improved Accuracy of Continuous Glucose Monitoring Systems in Pediatric Patients with Diabetes Mellitus: Results from Two Studies. [2018]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluation of the Long-Term Cost-Effectiveness of the Dexcom G6 Continuous Glucose Monitor versus Self-Monitoring of Blood Glucose in People with Type 1 Diabetes in Canada. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A Modified CGM Algorithm Enhances Data Availability While Retaining iCGM Performance. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Sustainable Use of a Real-Time Continuous Glucose Monitoring System from 2018 to 2020. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Real-World Evidence and Glycemic Improvement Using Dexcom G6 Features. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Perceived Burdens and Benefits Associated With Continuous Glucose Monitor Use in Type 1 Diabetes Across the Lifespan. [2022]