Peer Mentoring for Type 1 Diabetes

(Glu-COACH Trial)

Overseen By Robin Whittemore, PhD, APRN, FAAN

Age: < 65

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

38 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Black and Latinx teens with type 1 diabetes improve their use of a continuous glucose monitor (CGM), a device that continually tracks blood sugar to aid in management. The study will explore whether a peer mentor from the same cultural background enhances CGM use, potentially leading to better health outcomes. Teens who have type 1 diabetes, are Black or Latinx, and have used their CGM less than half the time in the past three months may qualify. The trial includes enhanced standard-of-care (ESOC) plus peer mentoring and a social media group for support. As an unphased trial, this study offers a unique opportunity for personalized health management support.

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 prior data suggests that this peer mentoring intervention is safe for adolescents with type 1 diabetes?

Research has shown that the Dexcom G6 Continuous Glucose Monitoring (CGM) System is generally safe to use. Studies have demonstrated that it provides accurate blood sugar readings compared to lab tests, which is crucial for effective diabetes management.

Tested in over 260 people, the Dexcom G6 confirmed its safety and effectiveness. The FDA has also approved it for checking blood sugar levels, adding extra confidence in its safety.

Overall, the Dexcom G6 CGM system is easy to use and offers a reliable way to monitor glucose levels without frequent finger pricks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Glu-COACH because it combines enhanced standard-of-care with peer mentoring tailored to cultural identities, specifically for Black and Latinx teens with Type 1 Diabetes. This approach is unique because it adds a social support element, pairing teens with mentors who share their cultural background, which can help with the initiation and maintenance of continuous glucose monitoring (CGM) systems like Dexcom. Additionally, the integration of a private social media group aims to foster a supportive community, which is not typically part of traditional diabetes management. This method could enhance engagement and adherence, leading to better health outcomes.

What evidence suggests that this peer mentoring intervention is effective for increasing CGM usage in Black and Latinx adolescents with type 1 diabetes?

Research has shown that continuous glucose monitoring (CGM) systems, such as the Dexcom G6, effectively manage type 1 diabetes. One study found that using the Dexcom G6 significantly lowered average blood sugar levels over six months. Specifically, A1C levels dropped from 9.4% to 7.1%, indicating better diabetes control. Other studies have demonstrated that CGM is more cost-effective and improves quality of life compared to traditional methods. In this trial, the Glu-COACH program aims to help Black and Latinx teens better utilize these effective CGM systems through peer mentoring, alongside enhanced standard-of-care. ^{3 6 7 8 9}

Who Is on the Research Team?

Robin Whittemore, PhD, APRN, FAAN

Principal Investigator

Yale School of Nursing

Stuart A Weinzimer, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Glu-COACH Experimental Treatment 1 Intervention

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)

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+

Published Research Related to This Trial

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]

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 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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7757524/

Performance of the Dexcom G6 Continuous Glucose ... This study demonstrated that the Dexcom G6 CGM System provided accurate readings in comparison to reference YSI blood glucose values and that sensors were well ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35298036/

Long-term cost-effectiveness of Dexcom G6 real-time ... Due to improved clinical outcomes and QoL gains rt-CGM is highly cost-effective compared with SMBG and FGM in people with T1D in Australia.

3. diabetesjournals.org diabetesjournals.org/clinical/article/42/4/540/157065/The-Dexcom-Community-Glucose-Monitoring-Project-6

The Dexcom Community Glucose Monitoring Project: 6-Month ... After 6 months of program participation, mean A1C decreased by 2.4 ± 1.9% from baseline to 6-month follow-up (from 9.4 ± 1.7 to 7.1 ± 1.2%, P <0.001).

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/dme.15519

Clinical outcomes of a real‐world prospective study using ... This study assessed real-world glycaemic outcomes associated with the use of Dexcom ONE in adults with suboptimally controlled diabetes.

5. tandfonline.com tandfonline.com/doi/full/10.2147/CEOR.S304395

Full article: Evaluation of the Long-Term Cost-Effectiveness ... The Dexcom G6 RT-CGM system improves glycemic control and reduces the risk of costly long-term diabetes-related complications, providing a cost- ...

6. dexcom.com dexcom.com/en-us/g6-cgm-system

Dexcom G6 CGM System | No Fingersticks, No Scanning The Dexcom G6 Continuous Glucose Monitoring (CGM) System sends real-time glucose readings automatically to a compatible smart device* or Dexcom receiver.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7957382/

Real-World Evidence and Glycemic Improvement Using ... The G6 CGM System (Dexcom, Inc., San Diego, CA, USA) provides users with the opportunity to see their current sensor glucose value (SGV) and up to 24 h of ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN170088.pdf

den170088 summary - accessdata.fda.gov Completed: n=262. Pivotal study to evaluate effectiveness and safety ofthe G6 Continuous Glucose. Monitoring System compared to a laborato1y blood glucose ...

9. amcp.org amcp.org/dexcom-g6-continuous-glucose-monitoring-cgm-system-outcomes-and-patient-engagement-real-world-data

The Dexcom G6 Continuous Glucose Monitoring (CGM ... Advances in the Dexcom G6 technology are an important CGM differentiator that allows for improved safety, glycemic management and telehealth opportunities.