An interventional study of CGM-guided care in Prediabetes, sponsored by HealthPartners Institute. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by HealthPartners Institute · Not applicable, Interventional, and Health services research
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.
The intention of the CGM-Guided Lifestyle Care intervention is to help CGM users make optimal use of their real-time and retrospective CGM data for the purpose of identifying and making behavior changes that reduce TA140. The CGM device will be positioned as a tool that guides its user to develop and maintain a personalized approach to eating, movement, and other behaviors such as sleep and stress management, which can all help bring glucose into a "healthy" range.
The proposed CGM-based intervention aims to explore an alternative approach to caring for people with prediabetes using a flexible, predominantly virtual approach. The emphasis on choosing healthy lifestyle behaviors, such as high-quality eating patterns and engaging in physical activity is similar to existing DPPs, while the mix of synchronous and asynchronous virtual care education, along with the personalized, actionable glycemic data reduces some of the known barriers to participation in current Diabetes Prevention Programs (DPPs) (e.g. rigid schedules, time). The emphasis on encouraging participants to use their own glucose data to see in real-time what healthy lifestyle choices work best for them is also a key differentiator from past approaches, which has the potential to lead to more sustainable behavior changes.
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's planned enrollment of 330 is above the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →HealthPartners Institute is the lead sponsor of 167 studies on the registry; 20 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 16 (94%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: CGM-guided care
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.
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.
Change in CGM-derived % TA140
Time frame: Baseline to 12 months
Plan to share: Yes — De-identified individual participant-level data may be requested after the completion of the primary endpoint analysis, and reasonable requests to provide data will be considered. Any identifiers linking to the participant will be excluded. De-identified data may be used for secondary research purposes and may be shared with researchers not affiliated with the institution conducting the research project when appropriate contractual agreements are in place. The study consent denotes that de-identified personal data may be used by researchers for secondary research purposes, presentations, or publications without additional permission from the study participant.
Supporting information: Study protocol
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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