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

Last updated: July 3, 2024
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus Types I And Ii

Diabetes And Hypertension

Diabetes Mellitus, Type 1

Treatment

Enhanced standard-of-care (ESOC)

Glu-COACH

Clinical Study ID

NCT06171412
2000033606
1R01DK134977-01
  • Ages 13-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of type 1 diabetes, as determined clinically by the presence of ketosis orketoacidosis at presentation and/or the presence of at least one diabetes-relatedauto-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 otherinterview (parents/caregivers do not need to have English fluency)

  • Access to personal cellphone or tablet to participate in remote video sessions withthe peer mentor

  • Naïve to or not currently using CGM. "Current" use is defined as any CGM used forclinical management of T1D for > 1 week within the last three months.

Exclusion

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 opinionof the investigators, interfere with the conduct of the study or present additionalrisk to the individual.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Enhanced standard-of-care (ESOC)
Phase:
Study Start date:
May 21, 2024
Estimated Completion Date:
February 28, 2027

Study 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.

Connect with a study center

  • Yale Children's Diabetes Clinic

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

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