Glu-COACH: a Peer-mentoring Intervention to Reduce Disparities in Continuous Glucose Monitor (CGM) Use
Glu-COACH
2 other identifiers
interventional
38
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2023
CompletedFirst Posted
Study publicly available on registry
December 14, 2023
CompletedStudy Start
First participant enrolled
May 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
July 17, 2025
July 1, 2025
2.7 years
December 5, 2023
July 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (14)
CGM Mean glucose
baseline, 3 months and 6 months
CGM Percentage time in range (70-180mg/dL)
baseline, 3 months and 6 months
Mean A1C concentration
baseline, 3 months and 6 months
Number of Adverse diabetes-related events (diabetic ketoacidosis)
baseline, 3 months and 6 months
Number of Adverse diabetes-related events (severe hypoglycemia)
baseline, 3 months and 6 months
- +9 more secondary outcomes
Study Arms (1)
Glu-COACH
EXPERIMENTALThe 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)
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yale Children's Diabetes Clinic
New Haven, Connecticut, 06520, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robin Whittemore, PhD, APRN, FAAN
Yale School of Nursing
- PRINCIPAL INVESTIGATOR
Stuart A Weinzimer, MD
Yale University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2023
First Posted
December 14, 2023
Study Start
May 21, 2024
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
July 17, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- After completion of the funded project period for the parent award and upon acceptance of the data for publication.
- 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.
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.