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NOT YET RECRUITING
NCT07832474
NA

Returning to Normoglycemia With Targeted Use of Real-time CGM Data and Nutrition-focused Lifestyle Changes

Sponsor: HealthPartners Institute

View on ClinicalTrials.gov

Summary

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.

Official title: Continuous Glucose Monitoring in People With Prediabetes: a 12-month Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

330

Start Date

2026-10-01

Completion Date

2029-05

Last Updated

2026-09-22

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

CGM-guided care

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.

Locations (1)

HealthPartners

Bloomington, Minnesota, United States