Type 1 Together: A Peer Mentorship Program to Bolster Use of CGM

Nemours Children's Health

Status: Active, not recruiting

Conditions: Diabetes Mellitus, Type 1

Treatments: Behavioral: Type 1 Together; Behavioral: Standard of Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06203067

5438

1990806

P20GM144270 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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?

Enrollment: 37 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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37 participants in 2 patient groups

Type 1 Together

Experimental group

Description:

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.

Treatment:

Behavioral: Type 1 Together

Standard of Care

Active Comparator group

Description:

Quarterly clinic visits with endocrinology provider.

Treatment:

Behavioral: Standard of Care