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?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
37
Quarterly clinic visits with endocrinology provider.
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.
Nemours Children's Hospital, Delaware
Wilmington, Delaware, United States
Intervention Acceptability
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).
Time frame: 6 months post-enrollment
Perceptions of continuous glucose monitoring systems
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).
Time frame: Baseline and 3, 6, 9, and 12 months post-enrollment.
Continuous Glucose Monitoring System Use
The number of days a patient wore their continuous glucose monitoring system at least 12 hours over the past month.
Time frame: Baseline and 3, 6, 9, and 12 months post-enrollment
HbA1c
HbA1c expressed as a percentage of glycosylated hemoglobin
Time frame: Baseline and 3, 6, 9, and 12 months post-enrollment
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