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NCT07148713 · ClinicalTrials.gov registry record · NA
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
A NA study of Type 2 Diabetes and Diabetes Type 2, sponsored by University of North Carolina, Chapel Hill.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT07148713: Recruiting NA study of Type 2 Diabetes and Diabetes Type 2, sponsored by University of North Carolina, Chapel Hill.
NCT07148713 is a NA study of Type 2 Diabetes and Diabetes Type 2 that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 60 participants, below the 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07148713, a NA study of Type 2 Diabetes and Diabetes Type 2, is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL CGM-Augmented FIM
- BEHAVIORAL FIM only
Study Locations (1)
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-09-19 |
| Est. Completion | 2026-06 |
| Phase | NA |
What NCT07148713 shows while recruiting
NCT07148713 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (98% lower).
The record links to 7 conditions, with Type 2 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which CGM-Augmented FIM is the first listed.
NCT07148713 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT07148713 about?
NCT07148713 is a clinical study titled "Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine". 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 acc...
What is the current status of trial NCT07148713?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-09-19. Estimated completion is 2026-06.
What conditions does trial NCT07148713 study?
This clinical trial studies the following conditions: Type 2 Diabetes, Diabetes Type 2, Nutrition, T2DM (Type 2 Diabetes Mellitus), T2DM.
What interventions are being tested in trial NCT07148713?
The interventions under investigation include: CGM-Augmented FIM (BEHAVIORAL), FIM only (BEHAVIORAL).
Who is sponsoring clinical trial NCT07148713?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07148713 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07148713's enrollment target sits among peer trials
60 192nd of 327 higher than 124 of 327 other Type 2 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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