RECRUITING

Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pilot of a CGM-Augmented Food Is Medicine Intervention

Quick Facts

Study Start:2025-09
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07148713

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to complete study activities in English
  2. * Aged ≥18 years
  3. * Type 2 diabetes as defined by self-report and confirmed by ICD-10 codes
  4. * 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.
  5. * 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.
  6. * If taking Glucose-like peptide-1 receptor agonist (GLP-1 RA), it must be stable for at least 1 month prior to enrollment, with no plans to change dose during study period.
  7. * 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
  8. * 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))
  9. * Any positive screen on the FSSM, Gretchen Swanson Nutrition Screener, or NSS
  10. * No plans to move from the area for at least 4 months
  11. * Willing and able to provide written informed consent and participate in all study activities
  1. * Type 1 or other diabetes
  2. * Use of insulin or secretagogues in the preceding 6 months
  3. * Use of CGM in the preceding 6 months
  4. * 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
  5. * Known psychosis or major psychiatric illness that prevents participation with study activities
  6. * 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
  7. * Participant in diabetes, nutrition, or weight research intervention in last 12 months
  8. * GLP-1 RA dose in active titration phase.

Contacts and Locations

Study Contact

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

Principal Investigator

Anna Kahkoska, MD, PhD
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Anna Kahkoska, MD, PhD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09
Study Completion Date2026-06

Study Record Updates

Study Start Date2025-09
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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