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

Yale University

Status: Enrolling

Conditions: Type 1 Diabetes

Treatments: Behavioral: Glu-COACH

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06171412

1R01DK134977-01 (U.S. NIH Grant/Contract)

2000033606

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 estimated patients

Sex: All

Ages: 13 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Glu-COACH

Experimental group

Description:

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)

Treatment:

Behavioral: Glu-COACH