Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine

NCT07148713 | Recruiting

• 2 other identifiers: 24-2950100001649496
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutrition; Type 2 Diabetes; T2DM; T2DM (Type 2 Diabetes Mellitus); Diabetes Education; Diabetes Type 2; Diabetes Mellitis

Keywords

Diabetes; T2DM; Nutrition; Food is Medicine; Continuous glucose monitor; Type 2 Diabetes; Food insecurity; Nutrition insecurity

Outcome Measures

Primary Outcomes (8)

• Change in percent of Time in Range (TIR)

  When using the blinded continuous glucose monitors (CGM), the percentage of sensor values between 70-180 mg/dL will be measured using 7-14 days of retrospective data at each time-point. Change in TIR will be calculated across time-points.

  Baseline at Week 0, Post-intervention at Week 12

• Change in percent of Time Below Range (TBR)

  When using the blinded continuous glucose monitors (CGM), the percentage of sensor values in the hypoglycemic range (\<70 mg/dL) will be measured using 7-14 days of retrospective data at each time-point. Change in TBR will be calculated across time-points.

  Baseline at Week 0, Post-intervention at Week 12

• Change in percent of Time Above Range (TAR)

  When using the blinded continuous glucose monitors (CGM), the percentage of sensor values in the hyperglycemia range (\>180 mg/dL) will be measured using 7-14 days of retrospective data at each time-point. Change in TAR will be calculated across time-points.

  Baseline at Week 0, Post-intervention at Week 12

• Glycemic variability

  When using the blinded continuous glucose monitors (CGM), glycemic variability will be assessed using the coefficient of variation (%CV). Change in %CV will be calculated across time-points.

  Baseline at Week 0, Post-intervention at Week 12

• Change in Hemoglobin A1c (HbA1c)

  HbA1c (%) reflects average glucose over the past 2-3 months. Value will be assessed by standardized laboratory assay for trial baseline and endpoint.

  Baseline at Week 0, Post-intervention at Week 12

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

  Participants will be contacted to collect two 24-hour dietary recalls per timepoint. Healthy Eating Index (HEI) scores will be calculated based on the recall responses using a scoring system providing cumulative points for participants eating from a select list of healthy food categories. The scores range from 0 to 100. An ideal overall Healthy Eating Index score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans (DGA).

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

• Change in Mediterranean diet scores

  Participants will be contacted to collect two 24-hour dietary recalls per timepoint. Mediterranean diet scores will be calculated based on the recall responses using a scoring system providing cumulative points for participants eating a set amount of serving from a select list of healthy food categories. The scores range from 0 to 9. An ideal overall Mediterranean diet score of 9 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans (DGA).

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

• Change in Dietary Approaches to Stop Hypertension (DASH) Scores

  Participants will be contacted to collect two 24-hour dietary recalls per timepoint. Dietary Approaches to Stop Hypertension (DASH) scores will be calculated based on the recall responses using a scoring system providing cumulative points for participants eating a set amount of serving from a select list of healthy food categories. The scores range from 8 to 40. An ideal overall DASH score of 40 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans (DGA).

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

Secondary Outcomes (15)

• Change in food security using the USDA Food Security Survey Module

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

• Change in the presence and/or degree of nutrition security from the Two-item Nutrition Security Screener (NSS)

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

• Change in the summed nutrition barrier score from the Two-item Nutrition Security Screener (NSS)

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

• Change in the One-Item Gretchen Swanson Nutrition Screener

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

• Change in Core Diabetes Distress using the Type 2 Diabetes Distress Assessment System (T2-DDAS) Core Score

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

Study Arms (2)

Intervention

EXPERIMENTAL

CGM-Augmented FIM

Behavioral: CGM-Augmented FIM

Comparator

ACTIVE COMPARATOR

FIM only

Behavioral: FIM only

Interventions

CGM-Augmented FIM BEHAVIORAL

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).

Intervention

FIM only BEHAVIORAL

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.

Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• American Heart Association: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Anna Kahkoska, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Penny Wang, MS

CONTACT

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

Angela Fruik, MPH, RD, LDN

CONTACT

919-962-6348; angela.fruik@unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants in the intervention arm will be blinded during Week 0 (Baseline) and Week 12 of the Intervention Phase for a period of 10-14 days to outcome assessments from the CGM wear.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: September 19, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: beginning 6 and continuing for 18 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)