NCT05854069

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 24 Years
• Healthy volunteers: Not accepted

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.

Detailed description

FAMS (Family/friend Activation to Motivate Self-care) is a mobile phone-delivered intervention, based on Family Systems Theory, which helps adults with diabetes set behavioral goals and improve support received from friends and family for goal success. FAMS includes monthly phone coaching and text message support by FAMS coaches for the person with diabetes (PWD) and the option to enroll a support person (SP) to receive automated texts tailored to the self-care goals the person with T1D sets in coaching sessions. Adaptations specific to CGM include the option to set CGM use goals in coaching (and receive associated text support) and skill-building exercises during coaching to support data sharing relationships (e.g., establishing, setting and adjusting ground rules about communication). Within the FAMS-T1D RCT (NCT05820477), we will test effects of FAMS-T1D on CGM use use relative to enhanced treatment as usual. We will evaluate effects on CGM use from baseline to post-intervention (6 months) as the primary endpoint. Study start date for the nested trial (NCT05854069) is the enrollment date of the first participant using a CGM. Since the goal of this trial is to assess effects of the adapted FAMS intervention on CGM use, the date participant CGM usage was confirmed is considered the enrollment date.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	FAMS-T1D	FAMS-T1D involves monthly phone coaching that assists individuals in setting specific and time bound diabetes goals with automated text message support to the patient participant and less frequent automated text messages to their support person, if one is enrolled. Behavioral: Diabetes Resources High quality digital materials about diabetes management will be provided upon enrollment and send to participants quarterly.
BEHAVIORAL	Digital resources for diabetes	Quality digital resources about diabetes management provided upon enrollment and during the study.

Timeline

• Start date: 2023-04-30
• Primary completion: 2027-01-31
• Completion: 2027-04-30
• First posted: 2023-05-11
• Last updated: 2025-10-29

Locations

2 sites across 1 country: United States