[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623118":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":19,"studyPopulation":23,"armGroups":24,"interventions":29,"overallOfficials":19,"centralContacts":35,"locations":41,"responsibleParty":61,"collaborators":19,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":19,"eligibilityCriteria":68,"healthyVolunteers":65,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":19,"studyType":75,"phases":19,"briefSummary":76,"conditions":77,"keywords":19,"overallStatus":44,"whyStopped":19,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":19},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Continuous Glucose measure derived glucometrics","To describe CGM-derived glucometrics in patients with PCOS before and after lifestyle modification and\u002For pharmacologic intervention.","6 months",{"measure":14,"description":15,"timeFrame":12},"Continuous Glucose measure derived glucometrics and Polycystic ovarian syndrome","To explore associations between CGM-derived glucometrics and PCOS-related clinical markers such as anti-mullerian hormone (AMH), HbA1c, lipid levels, body mass index, and body composition. Associations between glucometrics and PCOS-related clinical markers will be evaluated using correlations, two-sample t-tests or Pearson chi-square tests, as appropriate.",{"measure":17,"description":18,"timeFrame":12},"Lifestyle behaviors","To evaluate patient perception of CGM in influencing lifestyle behaviors. The survey includes 5 multiple choice questions and will be summarized using frequencies and percentages.",null,{"allocation":19,"interventionModel":19,"interventionModelDescription":19,"primaryPurpose":19,"observationalModel":21,"timePerspective":22,"maskingInfo":19},"COHORT","PROSPECTIVE","Patients diagnosed with polycystic ovarian syndrome (PCOS).",[25],{"label":26,"type":19,"description":26,"interventionNames":27},"Patients with Polycystic Ovarian Syndrome",[28],"Device: Stelo glucose biosensor by Dexcom",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":19},"DEVICE","Stelo glucose biosensor by Dexcom","Unblinded continuous glucose monitoring (CGM) system",[26],[36],{"name":37,"role":38,"phone":39,"phoneExt":19,"email":40},"Andrea Parianos, MS","CONTACT","216-445-8354","debsa@ccf.org",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Cleveland Clinic","RECRUITING","Cleveland","Ohio","44195","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-81.69541,41.4995,{"lat":54,"lon":53},[57],{"name":58,"role":38,"phone":59,"phoneExt":19,"email":60},"Jessica Holibaugh","216 550-3001","HOLIBAJ2@ccf.org",{"type":62,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100623118","continuous-glucose-monitoring-in-polycystic-ovarian-syndrome-100623118",false,"NCT07392476","Continuous Glucose Monitoring in Polycystic Ovarian Syndrome","Inclusion Criteria\n\n1. Adult 18-45 years old\n2. Diagnosis of PCOS by usual clinical method such as by Rotterdam criteria\n3. BMI \\>25 kg\u002Fm2\n\nExclusion Criteria\n\n1. Currently on medications that can improve glucose levels such as metformin and glucagon like receptor 1 agonists (GLP1RA) or on medications taken for the purpose of weight loss such as phentermine, topiramate, and bupropion.\n2. Previously intake of above-mentioned medications and less than 3 months since last intake of metformin or weight loss medications, and less than 6 months since last intake of GLP1RA\n3. Currently on insulin\n4. Does not have Stelo-compatible phone\n5. Fasting glucose \\>100 mg\u002FdL (because that is the cutoff for prediabetes) (either labs taken within a week after first visit or within 3 months before start of study\n6. HbA1c \\> 5.7% (because this is the cutoff for prediabetes) (either labs taken after screening visit or within 3 months before start of study)\n7. History of anorexia or bulimia\n8. Current or previous CGM use\n9. Use of oral contraceptives at time of enrolment\n10. Intent to become pregnant within 6 months (will need to terminate study if gets pregnant as glucose readings will be affected)\n11. Menopausal women","ALL","18 Years","45 Years",{"count":73,"type":74},40,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to learn more about blood sugar control in polycystic ovarian syndrome.\n\nThe patient will be asked to wear a continuous glucose monitor (CGM) device that is applied to the arm with a sensor or filament that goes under the skin to measure your sugar levels. The patient will wear this at certain time points throughout the study. There will have a total of 2 blood draws (about 1 tsp. of blood) at screening and the 6-month visit, a measure of the patients body muscle and fat (body composition), and fill out a questionnaire at the end of the first 3 months and 6 months.\n\nStudy participation in the research will last about 6 months.",[78],"Polycystic Ovarian Syndrome (PCOS)","2026-10-05",{"date":81,"type":82},"2026-10-06","ACTUAL",{"date":84,"type":82},"2025-12-24",{"date":86,"type":74},"2027-08-15",{"name":5,"class":6},1]