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 flexible, predominantly virtual approach. The emphasis on choosing healthy lifestyle behaviors, such as high-quality eating patterns and engaging in physical activity is similar to existing DPPs, while the mix of synchronous and asynchronous virtual care education, along with the personalized, actionable glycemic data reduces some of the known barriers to participation in current Diabetes Prevention Programs (DPPs) (e.g. rigid schedules, time). The emphasis on encouraging participants to use their own glucose data to see in real-time what healthy lifestyle choices work best for them is also a key differentiator from past approaches, which has the potential to lead to more sustainable behavior changes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
330
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.
HealthPartners
Bloomington, Minnesota, United States
Change in CGM-derived % TA140
Time frame: Baseline to 12 months
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