Pilot Study: CGM-Augmented Food Is Medicine for Type 2 Diabetes
This study is looking at how a "Food Is Medicine" (FIM) program, which provides healthy food vouchers, can help adults with type 2 diabetes. We want to see if adding a continuous glucose monitor (CGM) – a device that tracks blood sugar levels in real-time – and nutrition counseling makes the FIM program more effective. You could be eligible if you are an adult (18 or older) with type 2 diabetes and can complete study activities in English. The study will compare two groups: one receiving FIM with CGM and counseling, and another receiving FIM alone. Success will be measured by changes in your blood sugar levels, specifically how much time your blood sugar is in, below, or above the target range. The current recruitment status is unclear, and we plan to enroll 60 participants.
- Study design
- This is an interventional study that will randomize 60 participants into two groups for 16 weeks. One group will receive CGM-Augmented FIM, and the other will receive FIM only.
- What's involved
- You will wear a blinded CGM at the beginning and at week 12, and complete two 24-hour dietary recalls during each wear-time. If in the intervention arm, you will wear a real-time CGM for 12 weeks and have 5-8 nutrition counseling sessions. You will also provide outcome data at 12 and 16 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will provide outcome data at 12 weeks (post-intervention) and 16 weeks (after a 4-week extension phase).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Anna Kahkoska, MD, PhD · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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What this trial measures
- Change in percent of Time in Range (TIR)Baseline at Week 0, Post-intervention at Week 12
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.
- Change in percent of Time Below Range (TBR)Baseline at Week 0, Post-intervention at Week 12
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.
- Change in percent of Time Above Range (TAR)Baseline at Week 0, Post-intervention at Week 12
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.
- Glycemic variabilityBaseline at Week 0, Post-intervention at Week 12
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.
- Change in Hemoglobin A1c (HbA1c)Baseline at Week 0, Post-intervention at Week 12
HbA1c (%) reflects average glucose over the past 2-3 months. Value will be assessed by standardized laboratory assay for trial baseline and endpoint.
- Change in Healthy Eating Index (HEI) Score based on two 24-hour recallsBaseline at Week 0, Post-intervention at Week 12, Post-extension at Week 16
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).
- Change in Mediterranean diet scoresBaseline at Week 0, Post-Intervention at Week 12, Post-extension at Week 16
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).
- Change in Dietary Approaches to Stop Hypertension (DASH) ScoresBaseline at Week 0, Post-Intervention at Week 12, Post-extension at Week 16
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).