Pilot Study of Continuous Glucose Monitor-Enhanced Food Is Medicine Program for Adults with Type 2 Diabetes and Food Insecurity

What this Trial Is About

Researchers are evaluating a continuous glucose monitor CGM-augmented Food Is Medicine FIM intervention for adults with type 2 diabetes who face nutrition or food insecurity. The study aims to see if adding real-time CGM and nutrition counseling to a FIM program can increase engagement, improve blood sugar control, and support healthier eating compared to FIM alone. This pilot study will help test if the intervention is feasible and effective before a larger trial. Participants will be randomly assigned to one of two groups for the first 12 weeks the intervention group receives electronic healthy food vouchers, real-time CGM sensors, and 5 to 8 nutrition counseling sessions with a dietician the comparator group receives food vouchers and self-directed nutrition education without CGM or counseling. After 12 weeks, all participants enter a 4-week extension phase where they receive both the FIM intervention and real-time CGM for self-use. Data collection includes wearing blinded CGM at baseline and week 12, dietary recalls, and structured counseling for the intervention arm. During the 16-week study, participants will provide health data such as CGM readings, hemoglobin A1c levels, dietary intake, and patient feedback through questionnaires at weeks 12 and 16. A subset will be interviewed about their experiences to identify ways to improve the intervention. The study measures include changes in blood sugar control, diet quality, food security, diabetes distress, physical activity, and overall health. Researchers will also track adherence, satisfaction, and use of food subsidies throughout the trial.

Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine