HealthPartners Institute
The purpose of the ReTURN study is to understand how glycemia, specifically percent of time above 140 mg/dL (TA140), changes over time in people who are randomized to receive either continuous glucose monitoring (CGM)-guided care or usual care (UC) for 12 months. CGM-guided care includes daily use of a CGM system along with education and support. The hypothesis is that change in CGM-derived metrics from Baseline to Month 12 will show a larger improvement (reduction) in the CGM-Guided Lifestyle Change arm than the UC arm.
The intention of the CGM-Guided Lifestyle Care intervention is to help CGM users make optimal use of their real-time and retrospective CGM data for the purpose of identifying and making behavior changes that reduce TA140. The CGM device will be positioned as a tool that guides its user to develop and maintain a personalized approach to eating, movement, and other behaviors such as sleep and stress management, which can all help bring glucose into a "healthy" range. The proposed CGM-based intervention aims to explore an alternative approach to caring for people with prediabetes using a flexibl…
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. \> 18 years of age 3. Documented diagnosis of prediabetes based on the most recent A1c of 5.7% to 6.4% (inclusive) collected within the last 12 months; or with investigator approval based on a history of A1c 5.7% to 6.4% (inclusive) 4. Point-of-care A1c between 5.7% and 6.4% (inclusive) at screening visit 5. A minimum of 7 days of glucose data with documented % time above 140 mg/dL of \> 15% on a study-provided blinded CGM during the baseline assessment period 6. Ready and able to make lifestyle changes to prevent o…
Participants in the CGM arm use CGM data paired with a theory-informed behavioral intervention to guide personalized nutrition and lifestyle changes. The intervention aims to help CGM users make optimal use of their real-time and retrospective CGM data for the purposes of identifying and making behavior changes that reduce TA140. Participants in the CGM arm will receive support through three main components: 1) daily use of a real-time CGM system, 2) core CGM-guided lifestyle resources, and 3) personalized CGM-guided lifestyle education and support. The intervention focuses on food choices, physical activity, sleep, and stress reduction.
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