Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
NutritionType 2 DiabetesT2DMT2DM (Type 2 Diabetes Mellitus)Diabetes EducationDiabetes Type 2Diabetes Mellitis
Interventions
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.

Trial Locations (1)

27599

RECRUITING

University of North Carolina at Chapel Hill, Chapel Hill

All Listed Sponsors
collaborator

American Heart Association

OTHER

lead

University of North Carolina, Chapel Hill

OTHER