Trials / Recruiting

RecruitingNCT07148713

Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine

Pilot of a CGM-Augmented Food Is Medicine Intervention

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 60 (estimated)

Sponsor: University of North Carolina, Chapel Hill · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This study is designed to test the feasibility and preliminary efficacy of a continuous glucose monitor (CGM)-augmented food is medicine (FIM) intervention for adults with type 2 diabetes and nutrition or food insecurity. This study will learn if a FIM intervention ("intervention") that includes access to real-time CGM and nutrition counseling can increase engagement, improve glycemic management, and support healthy eating in this population, compared to the FIM intervention alone ("comparator"). At the study baseline, participants will be randomized to either the intervention or the comparator arm for 16 weeks. The intervention will occur during the first 12 weeks (phase 1: intervention phase) and will be compared to a standard FIM approach without CGM or counseling. Phase 2 (extension phase) will last 4 weeks and will consist of all participants in the intervention and comparator arm receiving both FIM and CGM for self-directed use. The study will also explore participant experiences through a series of semi-structured interviews with a subset of randomly selected participants to identify opportunities for scaling the intervention to a broader population.

Detailed description

This study is designed to test the feasibility and preliminary efficacy of a CGM-augmented FIM intervention for adults with type 2 diabetes and nutrition or food insecurity. The study will enroll adults with type 2 diabetes not using insulin/secretagogues or CGM to be randomized 1:1 to the CGM-augmented FIM intervention (intervention arm) or a standard FIM intervention (comparator arm) for 12 weeks. All participants (N=60) will wear blinded CGM for 10 to 14-days at baseline and at week 12, and complete two random 24-hour dietary recalls during each blinded CGM wear-time. Participants in the intervention arm will wear real-time CGM for the duration of the 12-week intervention and receive a series of structured counseling sessions with a registered dietician. Following the 12-week intervention, all participants will receive both FIM intervention and wear real-time CGM for a 4-week extension phase. FIM intervention will be provided in the form of electronic healthy food vouchers. At the 12-week and 16-week timepoints, participants will provide outcome data including blinded CGM data, hemoglobin A1c, dietary intake, and other patient-reported outcomes and feedback on their experience using questionnaires. After study completion, a subset of sampled participants will be invited to complete a semi-structured interview regarding their experience with the study. Participants in the intervention group will be invited after the completion of the intervention (beginning week 13) and participants in the comparator group will be invited to interview after completion of the entire study (beginning week 17). The primary outcomes measuring study feasibility and acceptability will collect data related to CGM and FIM use, including overall retention and phase completion, CGM wear-time, use of food subsidy, completion of meal logs, and satisfaction for the intervention. The primary outcomes measuring efficacy will collect diabetes outcomes, glycemic management, and a suite of patient-reported outcomes. Quantitative and qualitative results will be used to improve the intervention prior to rollout of a subsequent multicenter, fully powered randomized trial.

Conditions

Interventions

Type	Name	Description
BEHAVIORAL	CGM-Augmented FIM	The intervention arm will receive electronic healthy foods vouchers and unblinded, real-time CGM sensors for 16-weeks, in addition to individualized nutrition counseling with a registered dietician for 5-8 sessions (all participants will attend 5 sessions, with up to three additional sessions scheduled as needed based a set of a-priori decision rules).
BEHAVIORAL	FIM only	The comparator arm will receive electronic healthy foods vouchers and healthy eating resources and self-directed nutrition education. This group will not receive unblinded CGM sensors or any nutrition counseling for the first 12 weeks. This group will receive 30-days of unblinded CGM sensors to use in the extension phase only.

Timeline

Start date: 2025-09-19
Primary completion: 2026-06-01
Completion: 2026-06-01
First posted: 2025-08-29
Last updated: 2025-11-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07148713. Inclusion in this directory is not an endorsement.