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

Part of paid clinical trials in Bloomington, Minnesota.

Sponsor
HealthPartners Institute
Study ID
NCT07832474
Status
Not Yet Recruiting

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Conditions

  • Prediabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CGM-guided care — 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

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.

Key Dates

First listed
Sep 22, 2026
Start date
Oct 1, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2028
Completion
May 31, 2029

Study Design

Enrollment
330 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: CGM-Guided Lifestyle Care
    The CGM-guided care arm (the study intervention) includes three 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 education and support is provided via one 60-minute in-person education and counseling session, six 30-minute virtual systematic CGM data review and lifestyle assessment sessions, and three asynchronous systematic CGM data review and lifestyle assessment messages sent via the electronic health record. The intervention content is provided by a registered dietitian nutritionist and focuses on using CGM data to help people optimize food choices, physical activity levels, sleep patterns, and stress management for improved prediabetes management.
  • No Intervention: Usual Care (UC)
    Participants in the UC arm will receive generalized healthy lifestyle guidance and glycemic assessment (e.g. A1c, fasting glucose) at Baseline and at M12. Participants in the UC arm will also receive guidance for finding local diabetes prevention programs. The UC arm aligns with current practice for people with prediabetes.

Primary Outcome Measure

Change in CGM-derived % TA140 [ Time Frame: Baseline to 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
HealthPartnersBloomingtonMinnesota55425
Director of Research, IDC
[email protected]
952-993-3452

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By research site
HealthPartners· Bloomington, MN

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