Pilot of a CGM-Augmented Food Is Medicine Intervention
University of North Carolina, Chapel Hill
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.
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 in…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 consi…
Interventions
- BehavioralCGM-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).
- BehavioralFIM 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.
Location
- University of North Carolina at Chapel HillChapel Hill, North Carolina