Active — Not RecruitingNot Applicable

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

United States140 participantsStarted 2023-04-30

Plain-language 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.

Who can participate

Age range18 Years – 24 Years

SexALL

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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

What they're measuring

CGM frequency of use during the intervention period

Timeframe: Baseline and 6 months post-baseline

CGM frequency of use during the intervention period

Timeframe: Baseline and 6 months post-baseline

Gaps in CGM use

Timeframe: 6 months post-baseline

Trial details

NCT IDNCT05854069

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-31