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

ConditionPrediabetes

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorHealthPartners Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated informed consent form

> 18 years of age

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)

Point-of-care A1c between 5.7% and 6.4% (inclusive) at screening visit

Disqualifiers

Diagnosis of Type 1 diabetes or Type 2 diabetes (A1c >6.4%)

Taking or actively planning to take anti-hyperglycemic medications (e.g. Metformin, SGLT2i, GLP-1 RA)

Taking or actively planning to take prescription weight loss medications (e.g. Phentermine, Topiramate, Naltrexone, Orlistat)

Taking or actively planning to take a GLP-1 RA for any reason

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

330 Participants

are divided into 2 treatment groups

Group A: CGM-Guided Lifestyle CareExperimental treatment 1 intervention

Group B: Usual Care (UC)No intervention 0 interventions

Trial outcomes

Primary outcomes

Change in CGM-derived % TA140

Time frame

Baseline to 12 months

Sponsors and contacts

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HealthPartners Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: