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NCT06171412NARecruiting

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

Yale University

Start Date

5/21/2024

Completion Date

2/1/2027

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.

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.

Eligibility Criteria

Age Range: 13 years to 21 years

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.

Interventions

BEHAVIORAL

Glu-COACH

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Conditions

Type 1 Diabetes

Locations

Yale Children's Diabetes Clinic

New Haven, Connecticut 06520

United States