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Search / Trial NCT05854069

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

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · May 9, 2023

Trial Information

Current as of October 02, 2025

Enrolling by invitation

Keywords

Continuous Glucose Monitor Social Support Goal Setting Diabetes Distress Hemoglobin A1c Time In Range Emerging Adults Family Support Text Message Mobile Health

ClinConnect Summary

This study is testing an adapted version of FAMS-T1D, a mobile program that helps a person with Type 1 diabetes set self-care goals and get support from family or friends. The goal is to see if adding this program improves how often people use their continuous glucose monitor (CGM) and how well they share CGM data with supporters, compared with giving digital diabetes resources alone. Eligible participants are young adults aged 18–24 with Type 1 diabetes who have been on insulin for at least a year and are already using a CGM. To join, you must be able to text in English and have either an A1c of 7.5% or higher (or a positive screen for diabetes distress). A support person 18 or older can also join to receive tailored texts.

If you participate, you’ll be randomly assigned to either the FAMS-T1D program plus digital resources or to digital resources alone, for 6 months. The FAMS-T1D group gets monthly phone coaching and ongoing text support for both the person with diabetes and, if enrolled, their support person. All participants receive materials about accessing HbA1c results and general diabetes self-care. Researchers will track CGM use (how often the CGM is used), data sharing, and related behaviors and barriers, using both surveys and CGM data at the start and around 6 months (with some measures later). The study is currently enrolling by invitation at sites including Vanderbilt, University of Utah, UC Merced, and Children’s Hospital Los Angeles, and results are not yet available. De-identified data may be shared with researchers after results are published, upon request.

Gender

ALL

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

About Vanderbilt University Medical Center

Vanderbilt University Medical Center (VUMC) is a leading academic medical center located in Nashville, Tennessee, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, VUMC integrates cutting-edge scientific inquiry with patient-centered care, supporting a diverse array of studies aimed at enhancing medical knowledge and improving treatment outcomes. With a robust infrastructure and a multidisciplinary team of experts, VUMC fosters collaboration across various fields, ensuring the highest standards of safety and ethical considerations in its research endeavors. Through its dedication to medical discovery and education, VUMC plays a pivotal role in shaping the future of medicine.

Locations

Los Angeles, California, United States

Salt Lake City, Utah, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported