PrediabetesRETURNNCT07832474
Returning to Normoglycemia With Targeted Use of Real-time CGM Data and Nutrition-focused Lifestyle Changes
A study testing CGM-guided care in people with Prediabetes, run by HealthPartners Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prediabetes
- What is being tested?
- CGM-guided care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
HealthPartners
Bloomington, Minnesota, 55425
Director of Research, IDC, 952-993-3452, Rebecca.A.Passi@HealthPartners.com
About this study
Official title: Continuous Glucose Monitoring in People With Prediabetes: a 12-month Randomized Clinical 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.
Read the detailed description
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.
- Conditions
- Prediabetes
- Being tested
- CGM-guided care
- Keywords
- Continuous Glucose Monitoring, Glucose Metrics, Nutrition, Lifestyle
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGM-guided careBehavioural
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 group | Role | What they receive |
|---|---|---|
| CGM-Guided Lifestyle Care | Experimental | 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. Receives: Behavioral: CGM-guided care |
| Usual Care (UC) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CGM-derived % TA140
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832474
- Sponsor's protocol ID
- A25-185
- Other IDs
- IIS (25-32)
- Acronym
- RETURN
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Tabak AG, Herder C, Rathmann W, Brunner EJ, Kivimaki M. Prediabetes: a high-risk state for diabetes development. Lancet. 2012 Jun 16;379(9833):2279-90. doi: 10.1016/S0140-6736(12)60283-9. Epub 2012 Jun 9.
PubMed 22683128American Diabetes Association Professional Practice Committee for Diabetes*. 3. Prevention or Delay of Diabetes and Associated Comorbidities: Standards of Care in Diabetes-2026. Diabetes Care. 2026 Jan 1;49(Supplement_1):S50-S60. doi: 10.2337/dc26-S003.
PubMed 41358891Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
PubMed 11832527Knowler WC, Doherty L, Edelstein SL, Bennett PH, Dabelea D, Hoskin M, Kahn SE, Kalyani RR, Kim C, Pi-Sunyer FX, Raghavan S, Shah VO, Temprosa M, Venditti EM, Nathan DM; DPP/DPPOS Research Group. Long-term effects and effect heterogeneity of lifestyle and metformin interventions on type 2 diabetes incidence over 21 years in the US Diabetes Prevention Program randomised clinical trial. Lancet Diabetes Endocrinol. 2025 Jun;13(6):469-481. doi: 10.1016/S2213-8587(25)00022-1. Epub 2025 Apr 28.
PubMed 40311647Kent-Marvick J, Knysheva M, Gibson B, Simonsen SE. Why Do People Choose to Enroll or Not Enroll in the National Diabetes Prevention Program Lifestyle Change Program? A Mixed-Methods Analysis From a Sample of Adults With a Prediabetes Diagnosis. J Prim Care Community Health. 2024 Jan-Dec;15:21501319241282862. doi: 10.1177/21501319241282862.
PubMed 39305089Ackermann RT, O'Brien MJ. Evidence and Challenges for Translation and Population Impact of the Diabetes Prevention Program. Curr Diab Rep. 2020 Feb 20;20(3):9. doi: 10.1007/s11892-020-1293-4.
PubMed 32080770Polonsky WH, Clark TL, Soriano EC, Edgington A, Bennett CM, Fox AE, Grace T. How CGM Use in Adults With Type 2 Diabetes Leads to Glycemic Benefits: The Role of Medication and Behaviour Change. Endocrinol Diabetes Metab. 2026 May;9(3):e70236. doi: 10.1002/edm2.70236.
PubMed 42108772Golovaty I, Ritchie ND, Tuomilehto J, Mohan V, Ali MK, Gregg EW, Bergman M, Moin T. Two decades of diabetes prevention efforts: A call to innovate and revitalize our approach to lifestyle change. Diabetes Res Clin Pract. 2023 Apr;198:110195. doi: 10.1016/j.diabres.2022.110195. Epub 2022 Dec 5.
PubMed 36470316Ritchie ND, Baucom KJW, Sauder KA. Current Perspectives on the Impact of the National Diabetes Prevention Program: Building on Successes and Overcoming Challenges. Diabetes Metab Syndr Obes. 2020 Aug 19;13:2949-2957. doi: 10.2147/DMSO.S218334. eCollection 2020.
PubMed 32903871Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.
PubMed 21513547Bannuru RR, Bellini NJ, Bergenstal RM, Beverly EA, Christofides EA, Cox D, Ehrhardt N, Fazioli K, Hess Fischl A, Kerr D, Kirksey OW, Lau KHK, Martens TW, Noble M, Ranade PK, Shah VN, Willis HJ, ElSayed NA. Continuous Glucose Monitoring to Guide Lifestyle Choices With a Focus on Nutrition in the Management of Type 2 Diabetes: A Systematic Review and Meta-Analysis. J Diabetes Sci Technol. 2025 Oct 18:19322968251384318. doi: 10.1177/19322968251384318. Online ahead of print.
PubMed 41109846Fermin-Martinez CA, Bello-Chavolla OY, Paz-Cabrera CD, Ramirez-Garcia D, Perezalonso-Espinosa J, Fernandez-Chirino L, Vargas-Vazquez A, Diaz-Sanchez JP, Mendez-Labra PN, Nunez-Luna A, Basile-Alvarez MR, Sanchez-Castro P, Bragg F, Friedrichs LG, Aguilar-Ramirez D, Emberson JR, Berumen J, Kuri-Morales P, Tapia-Conyer R, Alegre-Diaz J, Seiglie JA, Antonio-Villa NE. Prediabetes and Risk of All-Cause and Cause-Specific Mortality: A Prospective Study of 114 062 Adults in Mexico City. J Clin Endocrinol Metab. 2025 Nov 18;110(12):3451-3460. doi: 10.1210/clinem/dgaf225.
PubMed 40208106Schlesinger S, Neuenschwander M, Barbaresko J, Lang A, Maalmi H, Rathmann W, Roden M, Herder C. Prediabetes and risk of mortality, diabetes-related complications and comorbidities: umbrella review of meta-analyses of prospective studies. Diabetologia. 2022 Feb;65(2):275-285. doi: 10.1007/s00125-021-05592-3. Epub 2021 Oct 31.
PubMed 34718834Echouffo-Tcheugui JB, Chakkalakal RJ, Ali MK. Is the Current Lifestyle Modification Approach to Diabetes Prevention in the U.S. a Success? Diabetes Care. 2025 Jun 1;48(6):863-870. doi: 10.2337/dci24-0040.
PubMed 40267363Rakoczi G, Nagy J, Jozaee S, Jozaee S, Szentes BL, Lee J, Rancz A, Hegyi P, Agocs G, Sipter E. Differences in Continuous Glucose Monitoring Metrics Between Prediabetes and Normoglycemia: A Systematic Review and Meta-Analysis. J Diabetes Sci Technol. 2026 Mar 3:19322968261426384. doi: 10.1177/19322968261426384. Online ahead of print.
PubMed 41773692
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring in People With Prediabetes: a 12-month Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07832474
- Acronym / sponsor ID
- RETURN / A25-185
- Conditions
- Prediabetes
- Keywords
- Continuous Glucose Monitoring, Glucose Metrics, Nutrition, Lifestyle
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGM-Guided Lifestyle Care | Experimental | Behavioral: CGM-guided careThe 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. |
| Usual Care (UC) | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGM-guided careParticipants 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. | Behavioural | CGM-Guided Lifestyle Care |
Primary outcome
Change in CGM-derived % TA140
Time frame: Baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 22683128Tabak AG, Herder C, Rathmann W, Brunner EJ, Kivimaki M. Prediabetes: a high-risk state for diabetes development. Lancet. 2012 Jun 16;379(9833):2279-90. doi: 10.1016/S0140-6736(12)60283-9. Epub 2012 Jun 9.
- Background: PubMed 41358891American Diabetes Association Professional Practice Committee for Diabetes*. 3. Prevention or Delay of Diabetes and Associated Comorbidities: Standards of Care in Diabetes-2026. Diabetes Care. 2026 Jan 1;49(Supplement_1):S50-S60. doi: 10.2337/dc26-S003.
- Background: PubMed 11832527Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
- Background: PubMed 40311647Knowler WC, Doherty L, Edelstein SL, Bennett PH, Dabelea D, Hoskin M, Kahn SE, Kalyani RR, Kim C, Pi-Sunyer FX, Raghavan S, Shah VO, Temprosa M, Venditti EM, Nathan DM; DPP/DPPOS Research Group. Long-term effects and effect heterogeneity of lifestyle and metformin interventions on type 2 diabetes incidence over 21 years in the US Diabetes Prevention Program randomised clinical trial. Lancet Diabetes Endocrinol. 2025 Jun;13(6):469-481. doi: 10.1016/S2213-8587(25)00022-1. Epub 2025 Apr 28.
- Background: PubMed 39305089Kent-Marvick J, Knysheva M, Gibson B, Simonsen SE. Why Do People Choose to Enroll or Not Enroll in the National Diabetes Prevention Program Lifestyle Change Program? A Mixed-Methods Analysis From a Sample of Adults With a Prediabetes Diagnosis. J Prim Care Community Health. 2024 Jan-Dec;15:21501319241282862. doi: 10.1177/21501319241282862.
- Background: PubMed 32080770Ackermann RT, O'Brien MJ. Evidence and Challenges for Translation and Population Impact of the Diabetes Prevention Program. Curr Diab Rep. 2020 Feb 20;20(3):9. doi: 10.1007/s11892-020-1293-4.
- Background: PubMed 42108772Polonsky WH, Clark TL, Soriano EC, Edgington A, Bennett CM, Fox AE, Grace T. How CGM Use in Adults With Type 2 Diabetes Leads to Glycemic Benefits: The Role of Medication and Behaviour Change. Endocrinol Diabetes Metab. 2026 May;9(3):e70236. doi: 10.1002/edm2.70236.
- Background: PubMed 36470316Golovaty I, Ritchie ND, Tuomilehto J, Mohan V, Ali MK, Gregg EW, Bergman M, Moin T. Two decades of diabetes prevention efforts: A call to innovate and revitalize our approach to lifestyle change. Diabetes Res Clin Pract. 2023 Apr;198:110195. doi: 10.1016/j.diabres.2022.110195. Epub 2022 Dec 5.
- Background: PubMed 32903871Ritchie ND, Baucom KJW, Sauder KA. Current Perspectives on the Impact of the National Diabetes Prevention Program: Building on Successes and Overcoming Challenges. Diabetes Metab Syndr Obes. 2020 Aug 19;13:2949-2957. doi: 10.2147/DMSO.S218334. eCollection 2020.
- Background: PubMed 21513547Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.
- Background: PubMed 41109846Bannuru RR, Bellini NJ, Bergenstal RM, Beverly EA, Christofides EA, Cox D, Ehrhardt N, Fazioli K, Hess Fischl A, Kerr D, Kirksey OW, Lau KHK, Martens TW, Noble M, Ranade PK, Shah VN, Willis HJ, ElSayed NA. Continuous Glucose Monitoring to Guide Lifestyle Choices With a Focus on Nutrition in the Management of Type 2 Diabetes: A Systematic Review and Meta-Analysis. J Diabetes Sci Technol. 2025 Oct 18:19322968251384318. doi: 10.1177/19322968251384318. Online ahead of print.
- Background: PubMed 40208106Fermin-Martinez CA, Bello-Chavolla OY, Paz-Cabrera CD, Ramirez-Garcia D, Perezalonso-Espinosa J, Fernandez-Chirino L, Vargas-Vazquez A, Diaz-Sanchez JP, Mendez-Labra PN, Nunez-Luna A, Basile-Alvarez MR, Sanchez-Castro P, Bragg F, Friedrichs LG, Aguilar-Ramirez D, Emberson JR, Berumen J, Kuri-Morales P, Tapia-Conyer R, Alegre-Diaz J, Seiglie JA, Antonio-Villa NE. Prediabetes and Risk of All-Cause and Cause-Specific Mortality: A Prospective Study of 114 062 Adults in Mexico City. J Clin Endocrinol Metab. 2025 Nov 18;110(12):3451-3460. doi: 10.1210/clinem/dgaf225.
- International Diabetes FederationLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Prediabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGM-guided care in people with Prediabetes, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Holly Willis, PhD, RDN, CDCES (952-993-3219, Holly.J.Willis@Healthpartners.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CGM-derived % TA140 (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07832474, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.