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Active Not Recruiting NCT05854069

Adapting FAMS to Optimize CGM Use Among Emerging Adults With Type 1 Diabetes

Conditions: Type 1 Diabetes

Sex: All
Ages: 18 Years – 24 Years
Healthy volunteers: No
Phase: NA
Enrollment: 140
Sponsor: Vanderbilt University Medical Center

Location: Children's Hospital of Los Angeles Los Angeles California

Summary

The goal of this clinical trial is to evaluate the efficacy of an adapted FAMS (Family/friend Activation to Motivate Self-care) intervention on CGM use among study participants who are CGM users. We will leverage the infrastructure of an NIDDK-funded RCT evaluating FAMS-T1D among N=280 emerging adults with T1D who have elevated hemoglobin A1c or elevated diabetes distress (NCT05820477). We anticipate at least 50% using CGM to be included in these analyses.

Eligibility Criteria

Inclusion Criteria: PERSONS WITH DIABETES * Ages 18-24 * Have a diagnosis of T1D and has been taking insulin for at least one year * Comfortable sending and receiving texts * Can speak, read, and write in English * Meets one of the following two criteria: 1) has a most recent A1c value in the EHR that is 7.5% or higher (or missing) OR 2) screen positive for diabetes distress on the two-item Diabetes Distress Screen (DDS-2) * Using a continuous glucose monitor (CGM) SUPPORT PERSONS * Age 18 or older * Can speak, read, and write in English or Spanish * Comfortable sending and receiving texts Exclusion Criteria: PERSONS WITH DIABETES * Has a condition that would prohibit study completion (intellectual disability, blindness or auditory limitations, severe mental illness) * Plans to live outside the country during the study period SUPPORT PERSONS * Shares a phone with the person with diabetes * Plans to live outside of the country during the study period

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05854069). StuddyBuddy aggregates publicly available trial information.