Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine

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.

NCT Number	NCT07148713
Lead Sponsor	University of North Carolina, Chapel Hill Collaborators: American Heart Association
Conditions	Nutrition, Type 2 Diabetes, T2DM, T2DM (Type 2 Diabetes Mellitus), Diabetes Education, Diabetes Type 2, Diabetes Mellitis
Enrollment	60 participants
Start Date	2025-09-19
Primary Completion	2026-06 (estimated)
Study Completion	2026-06 (estimated)
Updated on ClinicalTrials.gov	2025-11-12