Type 1 Together: a Peer Mentorship Program to Increase Equitable Use of Continuous Glucose Monitoring Systems

Not Applicable

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Behavioral: Type 1 Together; Behavioral: Standard of Care

• Registration Number: NCT06203067
• Lead Sponsor: Nemours Children's Clinic

Brief Summary

The goal of this clinical trial is to evaluate a new way of helping adolescents with type 1 diabetes consistently use continuous glucose monitoring systems (CGM).

Families who participate will be assigned by chance to one of two groups. One group will continue to see their Endocrinology provider who can give recommendations on ways to use CGM.

The other group will be in our Type 1 Together program for 6 months. This will include:

1. Monthly meetings with a community health worker with expertise in type 1 diabetes self-management,

2. Access to CGM-specific educational resources hosted on a mobile app, and

3. Meeting at least monthly with a mentor family who will provide mentorship on using CGM consistently.

The main questions the study aims to answer are:

1. Do families like the Type 1 Together program?

2. Do more families in the Type 1 Together program have better attitudes towards CGM, use CGM more consistently, and have lower HbA1c?

3. Does the Type 1 Together program reduce racial and ethnic differences in attitudes towards CGM, consistent use of CGM, and HbA1c?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-01-02
• Study First Posted: 2024-01-12
• Study Start: 2024-04-19
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10
• Primary Completion: 2027-02-28
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• 12 to 17 years old
• Diagnosed with type 1 diabetes for at least 6 months
• Does not use CGM OR uses CGM < 24 out of the past 30 days
• Use CGM 24 to 30 of the past 30 days but most recent HbA1c was 9% or more
• Able to read and write in English

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Exclusion Criteria

• Type 1 diabetes due to other medical condition (e.g., cystic fibrosis)
• Intellectual disability
• Severe psychiatric comorbidities

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Type 1 Together	Type 1 Together	In Type 1 Together, families will work with other families who have experience using CGM (Peer Mentors) to overcome common barriers to CGM use. Families in the Type 1 Together program will also have access to CGM-specific educational materials, a digital journal to facilitate patient-provider communication around issues with CGM, and social determinant of health screening and intervention with a diabetes community health worker.
Standard of Care	Standard of Care	Quarterly clinic visits with endocrinology provider.

Primary Outcome Measures

Name	Time	Method
Intervention Acceptability	6 months post-enrollment	How acceptable youth and caregivers find Type 1 Together. This information will be collected only from participants in the experimental arm using the Acceptability of Intervention Measure (scores range 1-5 with higher scores indicating greater acceptability).
Perceptions of continuous glucose monitoring systems	Baseline and 3, 6, 9, and 12 months post-enrollment.	Youth perceptions of the benefits and burdens of using continuous glucose monitoring systems will be assessed using the CGM Benefits and Burdens Scales (scores range 1-5 with higher scores indicating greater perceived benefits or burdens).
Continuous Glucose Monitoring System Use	Baseline and 3, 6, 9, and 12 months post-enrollment	The number of days a patient wore their continuous glucose monitoring system at least 12 hours over the past month.
HbA1c	Baseline and 3, 6, 9, and 12 months post-enrollment	HbA1c expressed as a percentage of glycosylated hemoglobin

Trial Locations

Locations (1)

Nemours Children's Hospital, Delaware; 🇺🇸 Wilmington, Delaware, United States