Actively Recruiting
Pilot of a CGM-Augmented Food Is Medicine Intervention for Adults with Type 2 Diabetes and Food Insecurity
Led by University of North Carolina, Chapel Hill · Updated on 2025-11-12
60
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating a continuous glucose monitor (CGM)-augmented Food Is Medicine (FIM) intervention for adults with type 2 diabetes who face nutrition or food insecurity. The study aims to see if adding real-time CGM and nutrition counseling to a FIM program can increase engagement, improve blood sugar control, and support healthier eating compared to FIM alone. This pilot study will help test if the intervention is feasible and effective before a larger trial. Participants will be randomly assigned to one of two groups for the first 12 weeks: the intervention group receives electronic healthy food vouchers, real-time CGM sensors, and 5 to 8 nutrition counseling sessions with a dietician; the comparator group receives food vouchers and self-directed nutrition education without CGM or counseling. After 12 weeks, all participants enter a 4-week extension phase where they receive both the FIM intervention and real-time CGM for self-use. Data collection includes wearing blinded CGM at baseline and week 12, dietary recalls, and structured counseling for the intervention arm. During the 16-week study, participants will provide health data such as CGM readings, hemoglobin A1c levels, dietary intake, and patient feedback through questionnaires at weeks 12 and 16. A subset will be interviewed about their experiences to identify ways to improve the intervention. The study measures include changes in blood sugar control, diet quality, food security, diabetes distress, physical activity, and overall health. Researchers will also track adherence, satisfaction, and use of food subsidies throughout the trial.
CONDITIONS
Brief 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 above 8.0% in the last 12 months
- Receiving primary or specialty care within UNC Health in the past year
- Experience of food insecurity or nutrition insecurity based on specific screening tools
- No plans to move away for at least 4 months
- Willing and able to provide informed consent and participate fully in study activities
You will not qualify if you...
- Diagnosis of type 1 or other types of diabetes
- 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 psychosis or major psychiatric illness preventing participation
- Pregnancy or planned pregnancy in the next 4 months
- Participation in diabetes, nutrition, or weight research in the last 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 to 14 days
Participants wear a blinded continuous glucose monitor (CGM) for 10 to 14 days and complete two random 24-hour dietary recalls during this period to establish baseline data.
1 baseline visit and CGM wear for 10 to 14 days
Duration - 12 weeks
Participants receive a 12-week intervention. The intervention arm wears real-time CGM sensors and participates in 5 to 8 nutrition counseling sessions with a registered dietician, while the comparator arm receives electronic healthy food vouchers and self-directed nutrition education without CGM or counseling during this time.
5 to 8 counseling sessions for intervention arm; food vouchers provided for all participants
Duration - 10 to 14 days
Participants wear blinded CGM again for 10 to 14 days and complete dietary recalls and questionnaires to assess outcomes after the 12-week intervention.
1 visit and CGM wear for 10 to 14 days
Duration - 4 weeks
All participants receive the Food Is Medicine intervention and wear real-time CGM for an additional 4 weeks. This phase includes continued monitoring and support.
Real-time CGM wear and ongoing food voucher use
Duration - 1 to 2 weeks
Participants provide outcome data including CGM data, dietary intake, and patient-reported outcomes through questionnaires following the extension phase.
1 visit for outcome assessments
Duration - Variable timing after study completion
A subset of participants is invited to complete semi-structured interviews about their experience with the study after completing the intervention or study.
1 interview visit
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
A
Angela Fruik, MPH, RD, LDN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here