NCT07148713 · University of North Carolina, Chapel Hill
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
(ALIGN)
What this study is about
This study is designed to test the feasibility and preliminary effectiveness of a continuous glucose monitor (CGM)-augmented food is medicine (FIM) intervention for adults with type 2 diabetes and nutrition or food insecurity.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Able to complete study activities in English
- Aged ≥18 years
- Type 2 diabetes as defined by self-report and confirmed by ICD-10 codes
- 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.
- 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.
- 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
- 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))
- Any positive screen on the FSSM, Gretchen Swanson Nutrition Screener, or NSS
- No plans to move from the area for at least 4 months
- Willing and able to provide written informed consent and participate in all study activities
Exclusion criteria
- Type 1 or other diabetes
- Use of insulin or secretagogues in the preceding 6 months
- Use of CGM in the preceding 6 months
- 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
- Known psychosis or major psychiatric illness that prevents participation with study activities
- 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
- Participant in diabetes, nutrition, or weight research intervention in last 12 months
Where
- Chapel Hill, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 12, 2025 · Source of record for eligibility and locations