Glu-COACH: a Peer-mentoring Intervention to Reduce Disparities in Continuous Glucose Monitor (CGM) Use (Glu-COACH)

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: Glu-COACH

Detailed Description

In Phase 1, investigators developed the intervention with a stakeholder advisory group. In Phase 2, investigators will conduct a small clinical trial to evaluate the intervention. Phase 1 is complete with the focus of this registration being Phase 2, the clinical trial.

All study procedures will be conducted remotely by ZOOM, including consent/assent, device and training, and peer mentor sessions.

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stuart A Weinzimer, MD; Phone Number: 877.925.3637; Email: stuart.weinzimer@yale.edu
• Study Contact Backup: Name: Robin Whittemore, PhD, APRN, FAAN; Phone Number: 203-737-2351; Email: robin.whittemore@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale Children's Diabetes Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of type 1 diabetes, as determined clinically by the presence of ketosis or ketoacidosis at presentation and/or the presence of at least one diabetes-related auto-antibody
• Self-identification as Black and/or Latinx.
• 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
• using CGM <50% of the time over the last 3 months

Exclusion Criteria:

• Participants with a prior severe skin reaction to CGM sensor or adhesive.
• Current use of CGM
• Current or planned pregnancy
• Inability to comprehend or communicate in spoken/written English
• Subjects with other medical or mental health conditions that would, in the opinion of the investigators, interfere with the conduct of the study or present additional risk to the individual.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glu-COACH; 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)	Behavioral: Glu-COACH; peer-mentoring support from a peer of the same cultural identity and access to a private social media group for all Black and Latinx teens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean hours per week CGM worn	Mean hours per week of documented CGM wear. This will be documented through the CGM program. The primary analysis will be CGM use time at 6 months between the two groups.	3 months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGM Mean glucose	The mean glucose in mg/dL	baseline, 3 months and 6 months
CGM Percentage time in range (70-180mg/dL)	Percentage of time participants glucose values are in the target range of 70-180 mg/dL	baseline, 3 months and 6 months
Mean A1C concentration	Mean A1C concentration	baseline, 3 months and 6 months
Number of Adverse diabetes-related events (diabetic ketoacidosis)	Number of Yes/no responses via self report of diabetic ketoacidosis	baseline, 3 months and 6 months
Number of Adverse diabetes-related events (severe hypoglycemia)	Number of Yes/no responses via self report of severe hypoglycemia	baseline, 3 months and 6 months
Mean score in Diabetes Distress using Problem Areas in Diabetes-Teen (PAID-T) survey	PAID-T is a 26 item survey that measures of diabetes-specific distress for teenagers with type 1 diabetes. Items are rated on a 6-point Likert scale: 1-2, not a problem; 3-4, a moderate problem; or 5-6, a serious problem. Item scores are summed to form a total score (range 26-156), with higher scores indicating greater distress.	baseline, 3 months and 6 months
Mean score Diabetes self-efficacy using Diabetes Management Self-Efficacy scale (DMSES)	Measures the diabetic patients confidence regarding diet, exercise and medical treatment. It is a 20 item survey. Responses are rated on a 5 point scale ranging from 1- ''can't do at all'' to 5- ''certain can do''. Item scores are summed to form a total score range 0-100 with higher scores indicating higher self-efficacy in performing diabetes self management activities.	baseline, 3 months and 6 months
Mean score Depressive symptoms using Patient Health Questionnaire-2 (PHQ-2)	The PHQ-2 is a 2 item questionnaire used to assess the frequency of depressed mood. Item scores are summed with a total score ranging from 0 to 6 with higher scores indicating higher frequency of depressed moods.	baseline, 3 months and 6 months
Mean score Anxiety symptoms using General Anxiety Disorder-7 (GAD-7)	General Anxiety Disorder- 7 (GAD-7) is a 7 item self report instrument that measures anxiety. Items are scored on a 4-point scale, ranging from "not at all (0)" to "nearly everyday (3)". Item scores are summed with a total score ranging from 0 to 21: 0-4 Minimal anxiety; 5-9 Mild anxiety; 10-14 Moderate anxiety; 15-21 Severe anxiety.	baseline, 3 months and 6 months
Mean score Family conflict using Diabetes Family Conflict Scale (DFCS)	DFCS is a 19-item measure of diabetes management and the implications it has on the caregiver-child relationship. Items are scored on a 3-point Likert scale (1 = never argue, 2 = sometimes argue, and 3 = always argue). Item scores are summed with a total scale range of 19 to 57 with higher scores indicating a higher level of conflict.	baseline, 3 months and 6 months
Mean score Benefits and burdens of CGM use	This survey consists of two sub-scales (one is benefits, one is burdens) with 8 items each. Each item scored Likert scale - Scored 1-5 Strongly Disagree to Agree. Items summed and divided by # of items. Mean score across participants. Each subscale range 1-5, with 5 indicating greater perceived benefits or burdens.	baseline, 3 months and 6 months
Mean Score Technology Attitudes	5 items scored on a Likert scale, scored 1-5 (strongly disagree to agree). Items summed and divided by # of items. Mean score across participants. Score range 1-5, with 5 indicating more positive attitude about technology.	baseline, 3 months and 6 months
Mean score Glu-Coach satisfaction scale	5 items scored on a Likert scale, scored 1-5 (not at all to extremely). Items summed and divided by # of items. Mean score across participants. Score range 1-5, with 5 indicating greater satisfaction.	3 months and 6 months
Mean count Barriers to Device Use	19 items with yes/no response. Mean number of barriers across participants. Higher value indicates more barriers.	3 months and 6 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Stuart A Weinzimer, MD, Yale University; Principal Investigator: Robin Whittemore, PhD, APRN, FAAN, Yale School of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: continuous glucose monitor
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2000033606; 1R01DK134977-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

De-identified data associated with the study, upon request for qualified academic investigators for non-commercial use. Meta-analysis data along with data content, format, and organization, will be available on request. Submitted data will comply with relevant data and terminology standards.

De-identified data will be made available upon request by the study principal investigators, and that these data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA). Names and Institutions of persons either given or denied access to the data, and the bases for such decisions, will be summarized in the annual progress report.

Data and secondary analysis of data will be maintained in a secure data-base on the Yale system.

• IPD Sharing Time Frame: After completion of the funded project period for the parent award and upon acceptance of the data for publication.
• IPD Sharing Access Criteria: Investigators agree to identify where the data will be available and how to access the data in any publications and presentations that the investigators author or co-author about these data, as well as acknowledge the funding source in any publications and presentations.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No