NCT07148713 Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
| NCT ID | NCT07148713 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Nutrition |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-09-19 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-09-19 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Anna Kahkoska, MD, PhD
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT07148713 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nutrition. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07148713 currently recruiting?
Yes, NCT07148713 is actively recruiting participants. Contact the research team at penny_wang@med.unc.edu for enrollment information.
Where is the NCT07148713 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT07148713 clinical trial?
NCT07148713 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Anna Kahkoska, MD, PhD at University of North Carolina, Chapel Hill. The trial plans to enroll 60 participants.