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

Type 1 Diabetes Clinical Trial

— Glu-COACH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06171412
• Other study ID #: 2000033606
• Secondary ID: 1R01DK134977-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: February 2027

Study information

• Verified date: March 2024
• Source: Yale University
• Contact: Stuart A Weinzimer, MD
• Phone: 877.925.3637
• Email: stuart.weinzimer[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: February 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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
• Enhanced standard-of-care (ESOC)
This group will receive ESOC including additional training and support on CGM beyond routine clinical practice.

Locations

Country	Name	City	State
United States	Yale Children's Diabetes Clinic	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean hours per week CGM worn	Mean hours per week of documented CGM wear. This will be documented through the CGM program. The primary analysis will be CGM use time at 6 months between the two groups.	3 months and 6 months
Secondary	CGM Mean glucose	The mean glucose in mg/dL	baseline, 3 months and 6 months
Secondary	CGM Percentage time in range (70-180mg/dL)	Percentage of time participants glucose values are in the target range of 70-180 mg/dL	baseline, 3 months and 6 months
Secondary	Mean A1C concentration	Mean A1C concentration	baseline, 3 months and 6 months
Secondary	Number of Adverse diabetes-related events (diabetic ketoacidosis)	Number of Yes/no responses via self report of diabetic ketoacidosis	baseline, 3 months and 6 months
Secondary	Number of Adverse diabetes-related events (severe hypoglycemia)	Number of Yes/no responses via self report of severe hypoglycemia	baseline, 3 months and 6 months
Secondary	Mean score in Diabetes Distress using Problem Areas in Diabetes-Teen (PAID-T) survey	PAID-T is a 26 item survey that measures of diabetes-specific distress for teenagers with type 1 diabetes. Items are rated on a 6-point Likert scale: 1-2, not a problem; 3-4, a moderate problem; or 5-6, a serious problem. Item scores are summed to form a total score (range 26-156), with higher scores indicating greater distress.	baseline, 3 months and 6 months
Secondary	Mean score Diabetes self-efficacy using Diabetes Management Self-Efficacy scale (DMSES)	Measures the diabetic patients confidence regarding diet, exercise and medical treatment. It is a 20 item survey. Responses are rated on a 5 point scale ranging from 1- ''can't do at all'' to 5- ''certain can do''. Item scores are summed to form a total score range 0-100 with higher scores indicating higher self-efficacy in performing diabetes self management activities.	baseline, 3 months and 6 months
Secondary	Mean score Depressive symptoms using Patient Health Questionnaire-2 (PHQ-2)	The PHQ-2 is a 2 item questionnaire used to assess the frequency of depressed mood. Item scores are summed with a total score ranging from 0 to 6 with higher scores indicating higher frequency of depressed moods.	baseline, 3 months and 6 months
Secondary	Mean score Anxiety symptoms using General Anxiety Disorder-7 (GAD-7)	General Anxiety Disorder- 7 (GAD-7) is a 7 item self report instrument that measures anxiety. Items are scored on a 4-point scale, ranging from "not at all (0)" to "nearly everyday (3)". Item scores are summed with a total score ranging from 0 to 21: 0-4 Minimal anxiety; 5-9 Mild anxiety; 10-14 Moderate anxiety; 15-21 Severe anxiety.	baseline, 3 months and 6 months
Secondary	Mean score Family conflict using Diabetes Family Conflict Scale (DFCS)	DFCS is a 19-item measure of diabetes management and the implications it has on the caregiver-child relationship. Items are scored on a 3-point Likert scale (1 = never argue, 2 = sometimes argue, and 3 = always argue). Item scores are summed with a total scale range of 19 to 57 with higher scores indicating a higher level of conflict.	baseline, 3 months and 6 months
Secondary	Mean score Benefits and burdens of CGM use	This survey consists of two sub-scales (one is benefits, one is burdens) with 8 items each. Each item scored Likert scale - Scored 1-5 Strongly Disagree to Agree. Items summed and divided by # of items. Mean score across participants. Each subscale range 1-5, with 5 indicating greater perceived benefits or burdens.	baseline, 3 months and 6 months
Secondary	Mean Score Technology Attitudes	5 items scored on a Likert scale, scored 1-5 (strongly disagree to agree). Items summed and divided by # of items. Mean score across participants. Score range 1-5, with 5 indicating more positive attitude about technology.	baseline, 3 months and 6 months
Secondary	Mean score Glu-Coach satisfaction scale	5 items scored on a Likert scale, scored 1-5 (not at all to extremely). Items summed and divided by # of items. Mean score across participants. Score range 1-5, with 5 indicating greater satisfaction.	3 months and 6 months
Secondary	Mean count Barriers to Device Use	19 items with yes/no response. Mean number of barriers across participants. Higher value indicates more barriers.	3 months and 6 months