Can a smart food program plus glucose tracking transform diabetes care?
NCT ID NCT07148713
First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 2 times
Summary
This study tests whether adding a continuous glucose monitor (CGM) and nutrition counseling to a food-as-medicine program helps adults with type 2 diabetes and food insecurity better manage their blood sugar. Sixty participants will be split into two groups: one gets the standard food program, the other gets the food program plus CGM and counseling for 12 weeks, followed by a 4-week extension where both groups use CGM. The goal is to see if the enhanced approach improves blood sugar control and healthy eating.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
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