Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine (NCT07148713)
Pilot of a CGM-Augmented Food Is Medicine Intervention
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of North Carolina at Chapel Hill — Chapel Hill, North Carolina
Age range: 18 Years
🧪 Interventions in This Study
- CGM-Augmented FIM (BEHAVIORAL)
- FIM only (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Nutrition
- Nourish Clinical Trial — Cleveland, Ohio
- Vitamin and Mineral Absorption From Milk and PBMAs — Chicago, Illinois
- Extended Release Protein Dosing — Addison, Illinois
- Impacts of Sugar Warnings on Weight Bias — Chapel Hill, North Carolina
- Nutrition for Precision Health, Powered by the All of Us — Birmingham, Alabama
Explore by condition: All Nutrition clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.