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.
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.
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
Parallel
CGM-Augmented FIM
BehavioralThe intervention arm will receive electronic healthy foods vouchers and unblinded, real-time CGM sensors for 16-weeks, in addition to individualized nutrition counseling with a registered dietician for 5-8 sessions (all participants will attend 5 sessions, with up to three additional sessions scheduled as needed based a set of a-priori decision rules).
FIM only
BehavioralThe comparator arm will receive electronic healthy foods vouchers and healthy eating resources and self-directed nutrition education. This group will not receive unblinded CGM sensors or any nutrition counseling for the first 12 weeks. This group will receive 30-days of unblinded CGM sensors to use in the extension phase only.
Change in percent of Time in Range (TIR)
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)
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)
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 variability
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 food security using the USDA Food Security Survey Module
Self-reported United States Department of Agriculture (USDA) Household Food Security Survey will be measured using the 6-item short form with a 30-day lookback period. Responses of either "often", "sometimes", and "yes" on the questionnaire are added up to produce a total raw score, which will be used to measure changes across timepoints in the study. A total raw score of 0-1 indicates high or marginal food security, 2-4 indicates low food security, and 5-6 indicates very low food security.
Change in the presence and/or degree of nutrition security from the Two-item Nutrition Security Screener (NSS)
Self-reported 2-item Nutrition Security Screener will be measured to assess the presence and/or degree of nutrition security with the following question: "Thinking about the last 12 months, how hard was it for you or your household to regularly get and eat healthy foods?" The scale yields a nutrition security score based on a 5-point Likert scale ranging from "Very Hard" to "Not hard at all". Responses of "Very Hard", "Hard", or "Somewhat Hard" yield the presence of nutrition insecurity.
Change in the summed nutrition barrier score from the Two-item Nutrition Security Screener (NSS)
Self-reported 2-item Nutrition Security Screener will be measured to assess sum of reasons of nutrition barriers with the following question: "People have different reasons for eating or not eating healthy foods. Please tell me which, if any, of the following reasons were true for you or your household in the last 12 months." Participants will have 14 choices to choose from indicating their reason(s) for nutrition barriers, with each reason counting as a score of 1. There is no limit on the number of choices. Each reason checked off will be summed for a total score used to compare between the timepoints for changes in nutrition barrier score.
Change in the One-Item Gretchen Swanson Nutrition Screener
Self-reported 1-item Gretchen Swanson Nutrition Screener will be measured to assess the participant's needs for support around accessing healthy foods by asking the following question: "In the last 12 months, I worried that the food I was able to eat would hurt my health and well-being." The scale yields a score based on the response rated on a 6-point Likert scale, ranging from Never, Rarely, Sometimes, Often, Always, and Don't know. Responses with "Sometimes", "Often", and "Always" yields a positive screen, indicating a need for support around accessing healthful foods. Responses with "Never", "Rarely", and "Don't know" yields a negative screen to indicate no need for support around accessing healthful foods.
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University of North Carolina, Chapel Hill
Lead sponsor
American Heart Association
Collaborator
