RecruitingNot Applicable

Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine

United States60 participantsStarted 2025-09-19

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * Us…

What they're measuring

Change in percent of Time in Range (TIR)

Timeframe: Baseline at Week 0, Post-intervention at Week 12

Change in percent of Time Below Range (TBR)

Timeframe: Baseline at Week 0, Post-intervention at Week 12

Change in percent of Time Above Range (TAR)

Timeframe: Baseline at Week 0, Post-intervention at Week 12

Glycemic variability

Timeframe: Baseline at Week 0, Post-intervention at Week 12

Change in Hemoglobin A1c (HbA1c)

Timeframe: Baseline at Week 0, Post-intervention at Week 12

Change in Healthy Eating Index (HEI) Score based on two 24-hour recalls

Timeframe: Baseline at Week 0, Post-intervention at Week 12, Post-extension at Week 16

Change in Mediterranean diet scores

Timeframe: Baseline at Week 0, Post-Intervention at Week 12, Post-extension at Week 16

Change in Dietary Approaches to Stop Hypertension (DASH) Scores

Trial details

NCT IDNCT07148713

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Penny Wang, MS

+1 (919) 843-7720 penny_wang@med.unc.edu

View on ClinicalTrials.gov More Nutrition trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in percent of Time in Range (TIR)

Timeframe: Baseline at Week 0, Post-intervention at Week 12

Change in percent of Time Below Range (TBR)

Timeframe: Baseline at Week 0, Post-intervention at Week 12

Change in percent of Time Above Range (TAR)

Timeframe: Baseline at Week 0, Post-intervention at Week 12

Glycemic variability

Timeframe: Baseline at Week 0, Post-intervention at Week 12

Change in Hemoglobin A1c (HbA1c)

Timeframe: Baseline at Week 0, Post-intervention at Week 12

Change in Healthy Eating Index (HEI) Score based on two 24-hour recalls

Timeframe: Baseline at Week 0, Post-intervention at Week 12, Post-extension at Week 16

Change in Mediterranean diet scores

Timeframe: Baseline at Week 0, Post-Intervention at Week 12, Post-extension at Week 16

Change in Dietary Approaches to Stop Hypertension (DASH) Scores