Continuous glucose monitor plus Food Is Medicine for adults with type 2 diabetes
Pilot of a CGM-Augmented Food Is Medicine Intervention
This pilot tests whether giving adults with type 2 diabetes who have food or nutrition insecurity a real-time continuous glucose monitor plus nutrition counseling and healthy food vouchers helps them manage blood sugar and eat healthier compared with food vouchers alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT07148713 on ClinicalTrials.gov |
What this trial studies
In a single-site, randomized 1:1 pilot at UNC Chapel Hill, 60 adults with type 2 diabetes and food or nutrition insecurity will be assigned to either a CGM-augmented Food Is Medicine (FIM) intervention with real-time CGM and structured dietitian counseling or to standard FIM (electronic healthy food vouchers) without CGM for 12 weeks. All participants will wear blinded CGM at baseline and week 12 and complete dietary recalls during those periods; the intervention arm will wear real-time CGM during the 12-week intervention. After week 12, all participants enter a 4-week extension where everyone receives both FIM and real-time CGM for self-directed use. Primary aims are feasibility and preliminary efficacy, with outcomes including CGM metrics, hemoglobin A1c, dietary intake, patient-reported outcomes, and qualitative interviews from a subset of participants.
Who should consider this trial
Good fit: Adults (age ≥18) with type 2 diabetes not using insulin or secretagogues, HbA1c >8% in the past year, who report food or nutrition insecurity and receive care within UNC Health are the intended participants.
Not a fit: People already using insulin or secretagogues, currently using a CGM, or without food/nutrition insecurity are unlikely to benefit from this specific pilot.
Why it matters
Potential benefit: If successful, combining real-time CGM with nutrition counseling and food vouchers could help food-insecure adults with type 2 diabetes improve blood sugar control and make healthier eating choices.
How similar studies have performed: Prior studies show CGM can improve glycemic metrics and Food Is Medicine programs can improve diet quality, but combining real-time CGM with FIM and structured counseling in food-insecure adults is largely untested and this pilot addresses that gap.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Anna Kahkoska, MD, PhD — University of North Carolina, Chapel Hill
- Study coordinator: Penny Wang, MS
- Email: penny_wang@med.unc.edu
- Phone: +1 (919) 843-7720
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.