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