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PrediabetesNutrition and dietDigital healthBehavioralMetabolicBehavioral

What this study is

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.

What's being tested

  • CGM-guided care

    Intervention · BEHAVIORAL

    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.

Study details

Official title
Continuous Glucose Monitoring in People With Prediabetes: a 12-month Randomized Clinical Trial
Sponsor
HealthPartners Institute
Conditions
Prediabetes
Enrolling
330 people
Starts
2026-10-01
Est. completion
2029-05
Design
Open-label, randomized, parallel groups
Record
View on ClinicalTrials.gov ↗