Clinical trial NCT06171412: Glu-COACH: a Peer-mentoring Intervention to Reduce Disparities in Continuous Glucose Monitor (CGM) Use
Official title: Glu-COACH: a Peer-mentoring Intervention to Reduce Disparities in Continuous Glucose Monitor (CGM) Use
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Keywords: continuous glucose monitor
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-12-14
Enrollment: 50
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: Mean hours per week CGM worn
timeFrame: 3 months and 6 months
Secondary outcomes:
measure: CGM Mean glucose
timeFrame: baseline, 3 months and 6 months
measure: CGM Percentage time in range (70-180mg/dL)
timeFrame: baseline, 3 months and 6 months
measure: Mean A1C concentration
timeFrame: baseline, 3 months and 6 months
measure: Number of Adverse diabetes-related events (diabetic ketoacidosis)
timeFrame: baseline, 3 months and 6 months
measure: Number of Adverse diabetes-related events (severe hypoglycemia)
timeFrame: baseline, 3 months and 6 months
measure: Mean score in Diabetes Distress using Problem Areas in Diabetes-Teen (PAID-T) survey
timeFrame: baseline, 3 months and 6 months
measure: Mean score Diabetes self-efficacy using Diabetes Management Self-Efficacy scale (DMSES)
timeFrame: baseline, 3 months and 6 months
measure: Mean score Depressive symptoms using Patient Health Questionnaire-2 (PHQ-2)
timeFrame: baseline, 3 months and 6 months
measure: Mean score Anxiety symptoms using General Anxiety Disorder-7 (GAD-7)
timeFrame: baseline, 3 months and 6 months
measure: Mean score Family conflict using Diabetes Family Conflict Scale (DFCS)
timeFrame: baseline, 3 months and 6 months
measure: Mean score Benefits and burdens of CGM use
timeFrame: baseline, 3 months and 6 months
measure: Mean Score Technology Attitudes
timeFrame: baseline, 3 months and 6 months
measure: Mean score Glu-Coach satisfaction scale
timeFrame: 3 months and 6 months
measure: Mean count Barriers to Device Use
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Children's Diabetes Clinic
state: Connecticut
Study officials:
affiliation: Yale School of Nursing
name: Robin Whittemore, PhD, APRN, FAAN
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Stuart A Weinzimer, MD
role: PRINCIPAL_INVESTIGATOR
References: