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RECRUITING

NCT07148713

Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine

Sponsor: University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

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.

Official title: Pilot of a CGM-Augmented Food Is Medicine Intervention

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-09-19

Completion Date

2026-06

Last Updated

2025-11-12

Healthy Volunteers

Conditions

Nutrition Type 2 Diabetes T2DM T2DM (Type 2 Diabetes Mellitus)Diabetes Education Diabetes Type 2 Diabetes 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.

Inclusion Criteria: * Able to complete study activities in English * Aged ≥18 years * Type 2 diabetes as defined by self-report and confirmed by ICD-10 codes * Chart review will be conducted by the study team and a diagnosis of type 2 diabetes (E.11.xx) from either the problem list or a diagnosis linked to an encounter will be used as confirmation. Discrepancies in diagnosis codes will be resolved by review of provider notes within the past 3 years. * HbA1c \> 8.0% in the last 12 months via point of care or venous measurement. If there are multiple values, the most recent one will be considered. * Receiving primary or specialty care within UNC Health as defined by at least one visit with a primary care provider or endocrine provider within the past year * Indication of a barrier to healthy eating consisting of report of food insecurity (defined as a score greater or equal to 1.0 on the 6-item USDA Food Security Survey Module (FSSM)) and/OR nutrition insecurity (defined as more often than 'Rarely' on the One-Item Gretchen Swanson Nutrition Screener, OR more often than 'Not Very Hard' on the Two-item Nutrition Security Screener (NSS)) * Any positive screen on the FSSM, Gretchen Swanson Nutrition Screener, or NSS * No plans to move from the area for at least 4 months * Willing and able to provide written informed consent and participate in all study activities Exclusion Criteria: * Type 1 or other diabetes * Use of insulin or secretagogues in the preceding 6 months * Use of CGM in the preceding 6 months * Inability to use CGM and related technology (e.g., the companion app), including lack of a smartphone that is compatible with Stelo (information on compatible phones available in Appendix 1) or known allergy to adhesive * Known psychosis or major psychiatric illness that prevents participation with study activities * Pregnancy or planned pregnancy in the next 4 months-glycemic targets are different for pregnant women compared to non-pregnant women with diabetes and our intervention is designed for non-pregnant glycemic targets * Participant in diabetes, nutrition, or weight research intervention in last 12 months

Locations (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States