Actively Recruiting
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
Led by University of North Carolina, Chapel Hill · Updated on 2025-11-12
60
Participants Needed
1
Research Sites
36 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
A
American Heart Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to complete study activities in English
- Aged 18 years or older
- Diagnosis of type 2 diabetes confirmed by medical records
- Hemoglobin A1c greater than 8.0% in the last 12 months
- Receiving primary or specialty care within UNC Health in the past year
- Evidence of food or nutrition insecurity based on standard screening tools
- No plans to move away for at least 4 months
- Willing and able to provide written informed consent and participate in all study activities
You will not qualify if you...
- Diagnosis of type 1 diabetes or other diabetes types
- Use of insulin or secretagogues in the past 6 months
- Use of continuous glucose monitoring in the past 6 months
- Inability to use CGM technology or lack of compatible smartphone
- Known allergy to CGM adhesive
- Major psychiatric illness or psychosis preventing study participation
- Pregnancy or planned pregnancy in the next 4 months
- Participation in diabetes, nutrition, or weight research in the last 12 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
P
Penny Wang, MS
CONTACT
A
Angela Fruik, MPH, RD, LDN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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