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Recruiting NCT06171412

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

No phase Interventional Type 1 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Glu-COACH.
Who it may be relevant to
Registry conditions: Type 1 Diabetes. Basic parameters: 13 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral 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 measures

  • Mean hours per week CGM worn [Time frame: 3 months and 6 months]
Secondary outcome measures (12)
  • CGM Mean glucose [Time frame: baseline, 3 months and 6 months]
  • CGM Percentage time in range (70-180mg/dL) [Time frame: baseline, 3 months and 6 months]
  • Mean A1C concentration [Time frame: baseline, 3 months and 6 months]
  • Number of Adverse diabetes-related events (diabetic ketoacidosis) [Time frame: baseline, 3 months and 6 months]
  • Number of Adverse diabetes-related events (severe hypoglycemia) [Time frame: baseline, 3 months and 6 months]
  • Mean score in Diabetes Distress using Problem Areas in Diabetes-Teen (PAID-T) survey [Time frame: baseline, 3 months and 6 months]
  • Mean score Diabetes self-efficacy using Diabetes Management Self-Efficacy scale (DMSES) [Time frame: baseline, 3 months and 6 months]
  • Mean score Depressive symptoms using Patient Health Questionnaire-2 (PHQ-2) [Time frame: baseline, 3 months and 6 months]
  • Mean score Anxiety symptoms using General Anxiety Disorder-7 (GAD-7) [Time frame: baseline, 3 months and 6 months]
  • Mean score Family conflict using Diabetes Family Conflict Scale (DFCS) [Time frame: baseline, 3 months and 6 months]
  • Mean score Benefits and burdens of CGM use [Time frame: baseline, 3 months and 6 months]
  • Mean Score Technology Attitudes [Time frame: baseline, 3 months and 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Yale Children's Diabetes Clinic — New Haven

Identifiers

NCT: NCT06171412 · 2000033606 · 1R01DK134977-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗