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 ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
- A minimum of 7 days of glucose data with documented % time above 140 mg/dL of > 15% on a study-provided blinded CGM during the baseline assessment period
- Ready and able to make lifestyle changes to prevent or delay the onset of T2D; this may include changes to food intake, physical activity, sleep, and stress (e.g. ready to: make dietary changes, willing to aim for > 150 mins of physical activity/week, etc.)
- Has a personal smartphone that is compatible with all study-required devices and apps (e.g. FreeStyle Libre family, Fitbit)
- Willing to download study-related apps and keep them updated and open on phone as required throughout the study (e.g. FreeStyle Libre family)
- Has regular access to Wi-Fi
- Willing and able to consistently view and use CGM data on a personal smartphone for up to 54 weeks
- Willing and able to continuously wear a study provided CGM sensor (back of the arm) and a study provided Fitbit activity tracker (band around the wrist) for up to 54 weeks
- Willing to attend in person and virtual study visits, willing to read MyChart messages, and willing to comply with all other study procedures and lifestyle considerations (Section 5.3, Lifestyle Considerations) for the duration of the study
- Speak and read in English
You can't join if
- 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
- Known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin
- Currently using or actively planning to use personal CGM, or have used personal CGM in last 30 days
- Started taking within the last 16 weeks or actively planning to take a glucocorticoid (oral or injected), statin, thiazide diuretic, second-generation antipsychotic, or HIV medications, as these agents may increase the risk of developing T2D
- Skin conditions that are not compatible with CGM wear
- Taking or planning to regularly take more than 500 mg of Vitamin C per day (due to potential for false glucose elevations)
- Planning pregnancy, pregnant, or lactating
- Actively participating in or planning to participate in a treatment program for prediabetes (e.g. a diabetes prevention program) or a clinical intervention study related to cardiometabolic health
- Unsuitable for participation due to any other cause, including but not limited to significant comorbidities, as determined by PI or MD oversight (e.g. examples for consideration, advanced cancer, unstable heart disease, active eating disorders, planned surgeries, cognitive impairments)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openHealthPartners
Bloomington, Minnesota, United States
- Director of Research, IDC · Contact952-993-3452Rebecca.A.Passi@HealthPartners.com
Study team
Sponsor
HealthPartners Institute
Study ID A25-185
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.