Recruiting

Glu-COACH

Sponsor:

Yale University

Code:

NCT06171412

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 13 - 21

Healthy Volunteers: Not accepted

Interventions

Glu-COACH

Study Details

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.

Conditions

Type 1 Diabetes

Study ID

NCT06171412

Start date

May 21, 2024

Status verified date

Jul, 2025

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 21

Healthy Volunteers: Not accepted

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 Design

Enrollment

38 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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)

Interventions

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

Primary outcome measure

  • Mean hours per week CGM worn [ Time Frame: 3 months and 6 months ]

Central Contacts and Locations

Central contacts

Stuart A Weinzimer, MD

877.925.3637stuart.weinzimer@yale.edu

Robin Whittemore, PhD, APRN, FAAN

203-737-2351robin.whittemore@yale.edu

Locations

Yale Children's Diabetes Clinic

Recruiting

New Haven, Connecticut, United States, 06520

More Information

Sponsor

Yale University

Last update posted

Jul 17, 2025

Last verified

Jul, 2025

Keywords

  • continuous glucose monitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2025-07-17.