Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine (ALIGN)
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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.
Full description
This study is designed to test the feasibility and preliminary efficacy of a CGM-augmented FIM intervention for adults with type 2 diabetes and nutrition or food insecurity. The study will enroll adults with type 2 diabetes not using insulin/secretagogues or CGM to be randomized 1:1 to the CGM-augmented FIM intervention (intervention arm) or a standard FIM intervention (comparator arm) for 12 weeks. All participants (N=60) will wear blinded CGM for 10 to 14-days at baseline and at week 12, and complete two random 24-hour dietary recalls during each blinded CGM wear-time. Participants in the intervention arm will wear real-time CGM for the duration of the 12-week intervention and receive a series of structured counseling sessions with a registered dietician. Following the 12-week intervention, all participants will receive both FIM intervention and wear real-time CGM for a 4-week extension phase. FIM intervention will be provided in the form of electronic healthy food vouchers.
At the 12-week and 16-week timepoints, participants will provide outcome data including blinded CGM data, hemoglobin A1c, dietary intake, and other patient-reported outcomes and feedback on their experience using questionnaires. After study completion, a subset of sampled participants will be invited to complete a semi-structured interview regarding their experience with the study. Participants in the intervention group will be invited after the completion of the intervention (beginning week 13) and participants in the comparator group will be invited to interview after completion of the entire study (beginning week 17). The primary outcomes measuring study feasibility and acceptability will collect data related to CGM and FIM use, including overall retention and phase completion, CGM wear-time, use of food subsidy, completion of meal logs, and satisfaction for the intervention. The primary outcomes measuring efficacy will collect diabetes outcomes, glycemic management, and a suite of patient-reported outcomes. Quantitative and qualitative results will be used to improve the intervention prior to rollout of a subsequent multicenter, fully powered randomized trial.
Enrollment
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Inclusion criteria
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Able to complete study activities in English
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Aged ≥18 years
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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.
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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.
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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
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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
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No plans to move from the area for at least 4 months
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Penny Wang, MS; Angela Fruik, MPH, RD, LDN
Data sourced from clinicaltrials.gov
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