Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
NCT ID: NCT07148713
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-09-19
2026-06-30
Brief Summary
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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.
Detailed Description
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At the 12-week and 16-week timepoints, participants will provide outcome data including blinded CGM data, hemoglobin A1c, dietary intake, and other patient-reported outcomes and feedback on their experience using questionnaires. After study completion, a subset of sampled participants will be invited to complete a semi-structured interview regarding their experience with the study. Participants in the intervention group will be invited after the completion of the intervention (beginning week 13) and participants in the comparator group will be invited to interview after completion of the entire study (beginning week 17). The primary outcomes measuring study feasibility and acceptability will collect data related to CGM and FIM use, including overall retention and phase completion, CGM wear-time, use of food subsidy, completion of meal logs, and satisfaction for the intervention. The primary outcomes measuring efficacy will collect diabetes outcomes, glycemic management, and a suite of patient-reported outcomes. Quantitative and qualitative results will be used to improve the intervention prior to rollout of a subsequent multicenter, fully powered randomized trial.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention
CGM-Augmented FIM
CGM-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).
Comparator
FIM only
FIM 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.
Interventions
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CGM-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).
FIM 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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American Heart Association
OTHER
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Anna Kahkoska, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Penny Wang, MS
Role: primary
Other Identifiers
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100001649496
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
24-2950
Identifier Type: -
Identifier Source: org_study_id