[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618800":3},{"organization":4,"outcomesModule":7,"designInfo":75,"detailedDescription":74,"studyPopulation":74,"armGroups":82,"interventions":94,"overallOfficials":74,"centralContacts":100,"locations":106,"responsibleParty":120,"collaborators":74,"id":124,"slug":74,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":125,"sex":131,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":74,"studyType":137,"phases":138,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":108,"whyStopped":74,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"Kangbuk Samsung Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":74},[9],{"measure":10,"description":11,"timeFrame":12},"Change in HbA1c from 3 to 6 months","Non-inferiority comparison of the adjusted change in glycated hemoglobin A1c (HbA1c) from month 3 (V2, randomization visit) to month 6 (V3, end of study). The non-inferiority margin is set at 0.3%. The periodic use group will be considered non-inferior to the continuous use group if the lower bound of the 97.5% one-sided confidence interval for the difference in HbA1c change (periodic minus continuous) is greater than -0.3%.","At 6 months (V3)",[14,17,20,22,25,28,31,34,37,41,44,47,50,53,56,59,62,65,68,71],{"measure":15,"description":16,"timeFrame":12},"Change in HbA1c","Adjusted change in glycated hemoglobin A1c (HbA1c) from month 3 to month 6, comparing periodic versus continuous CGM use groups.",{"measure":18,"description":19,"timeFrame":12},"Change in Blood Pressure","Adjusted change in systolic and diastolic blood pressure from month 3 to month 6, comparing periodic versus continuous CGM use groups.",{"measure":12,"description":21,"timeFrame":12},"Adjusted change in lipid parameters (LDL cholesterol, HDL cholesterol, total cholesterol, triglycerides) from month 3 to month 6, comparing periodic versus continuous CGM use groups.",{"measure":23,"description":24,"timeFrame":12},"Change in Body Weight","Adjusted change in body weight (kg) from month 3 to month 6, comparing periodic versus continuous CGM use groups.",{"measure":26,"description":27,"timeFrame":12},"Change in HOMA-IR","Adjusted change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) from month 3 to month 6, comparing periodic versus continuous CGM use groups.",{"measure":29,"description":30,"timeFrame":12},"Change in Diabetes Treatment Satisfaction (DTSQ)","Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score from month 3 to month 6, comparing periodic versus continuous CGM use groups. Higher scores indicate greater treatment satisfaction.",{"measure":32,"description":33,"timeFrame":12},"Change in Diabetes Self-Efficacy (K-DMSES)","Change in Korean-Diabetes Management Self-Efficacy Scale (K-DMSES) score from month 3 to month 6, comparing periodic versus continuous CGM use groups. Higher scores indicate greater self-efficacy.",{"measure":35,"description":36,"timeFrame":12},"Change in Diabetes Self-Care Activities (SDSCA-K)","Change in Summary of Diabetes Self-Care Activities Questionnaire-Korean (SDSCA-K) score from month 3 to month 6, comparing periodic versus continuous CGM use groups.",{"measure":38,"description":39,"timeFrame":40},"Time in Range 70-180 mg\u002FdL (Non-inferiority)","Non-inferiority comparison of percentage of time in glucose range 70-180 mg\u002FdL between periodic and continuous CGM use groups. Non-inferiority margin is 6%.","Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months",{"measure":42,"description":43,"timeFrame":40},"Time in Range 70-180 mg\u002FdL","Percentage of time in glucose range 70-180 mg\u002FdL, comparing periodic versus continuous CGM use groups.",{"measure":45,"description":46,"timeFrame":40},"Time in Tight Range 70-140 mg\u002FdL","Percentage of time in tight glucose range 70-140 mg\u002FdL, comparing periodic versus continuous CGM use groups.",{"measure":48,"description":49,"timeFrame":40},"Time Above Range 180 mg\u002FdL","Percentage of time above glucose range (\\>180 mg\u002FdL), comparing periodic versus continuous CGM use groups.",{"measure":51,"description":52,"timeFrame":40},"Time Above Range 250 mg\u002FdL","Percentage of time above glucose range (\\>250 mg\u002FdL), comparing periodic versus continuous CGM use groups.",{"measure":54,"description":55,"timeFrame":40},"Time Below Range 70 mg\u002FdL","Percentage of time below glucose range (\\\u003C70 mg\u002FdL), comparing periodic versus continuous CGM use groups.",{"measure":57,"description":58,"timeFrame":40},"Time Below Range 54 mg\u002FdL","Percentage of time below glucose range (\\\u003C54 mg\u002FdL), comparing periodic versus continuous CGM use groups.",{"measure":60,"description":61,"timeFrame":40},"Glucose Standard Deviation (SD)","Standard deviation of glucose levels, comparing periodic versus continuous CGM use groups.",{"measure":63,"description":64,"timeFrame":40},"Glucose Coefficient of Variation (CV)","Coefficient of variation of glucose levels, comparing periodic versus continuous CGM use groups.",{"measure":66,"description":67,"timeFrame":40},"Mean Amplitude of Glycemic Excursions (MAGE)","Mean amplitude of glycemic excursions, a measure of glucose variability, comparing periodic versus continuous CGM use groups.",{"measure":69,"description":70,"timeFrame":40},"Glucose Management Indicator (GMI)","Glucose Management Indicator, an estimate of HbA1c derived from CGM data, comparing periodic versus continuous CGM use groups.",{"measure":72,"description":73,"timeFrame":40},"Mean Glucose","Mean glucose level (mg\u002FdL), comparing periodic versus continuous CGM use groups",null,{"allocation":76,"interventionModel":77,"interventionModelDescription":78,"primaryPurpose":79,"observationalModel":74,"timePerspective":74,"maskingInfo":80},"RANDOMIZED","PARALLEL","This is a non-inferiority trial comparing periodic versus continuous use of CGM","TREATMENT",{"masking":81,"maskingDescription":74,"whoMasked":74},"NONE",[83,89],{"label":84,"type":85,"description":86,"interventionNames":87},"Periodic CGM Use","EXPERIMENTAL","All participants first wear FreeStyle Libre 2 CGM continuously for 12 weeks to establish baseline glucose patterns. Only those with at least 50% sensor active time proceed to randomization. After randomization, participants in this arm wear CGM intermittently for 2 weeks at weeks 2, 6, and 10 (±3 days each). Each sensor is worn for 14 days then removed. During non-wearing periods, no CGM is used. Participants receive education on diet adjustment based on postprandial glucose from CGM. Existing diabetes medications are maintained without changes throughout the study.",[88],"Device: FreeStyle Libre 2 Continuous Glucose Monitoring",{"label":90,"type":91,"description":92,"interventionNames":93},"Continuous CGM Use","ACTIVE_COMPARATOR","All participants first wear FreeStyle Libre 2 CGM continuously for 12 weeks to establish baseline glucose patterns. Only those with at least 50% sensor active time proceed to randomization. After randomization, participants in this arm continue to wear CGM continuously for 12 weeks with sensor replacement every 14 days (total 6 replacements). Participants receive education on diet adjustment based on postprandial glucose from CGM. Existing diabetes medications are maintained without changes throughout the study.",[88],[95],{"type":96,"name":97,"description":98,"armGroupLabels":99,"otherNames":74},"DEVICE","FreeStyle Libre 2 Continuous Glucose Monitoring","FreeStyle Libre 2 continuous glucose monitoring system consisting of a sensor worn on the upper arm that measures interstitial glucose levels continuously for up to 14 days. Data is transmitted to a smartphone app (FreeStyle LibreLink). The sensor is a Class 3 medical device approved by MFDS (Korea). Participants receive education on adjusting diet based on postprandial glucose patterns observed through CGM. Existing diabetes medications (oral agents and\u002For GLP-1 agonists) are maintained without changes throughout the intervention period.",[90,84],[101],{"name":102,"role":103,"phone":104,"phoneExt":74,"email":105},"Sun-Joon Moon, MD, PhD","CONTACT","+82-2-2001-1550","ipleat.m@gmail.com",[107],{"facility":5,"status":108,"city":109,"state":110,"zip":111,"country":110,"countryCode":74,"cosmosGeoPoint":112,"geoPoint":117,"contacts":118},"RECRUITING","Seoul","South Korea","03181",{"type":113,"coordinates":114},"Point",[115,116],126.9784,37.566,{"lat":116,"lon":115},[119],{"name":102,"role":103,"phone":104,"phoneExt":74,"email":105},{"type":121,"investigatorFullName":122,"investigatorTitle":123,"investigatorAffiliation":5,"oldNameTitle":74,"oldOrganization":74},"PRINCIPAL_INVESTIGATOR","Sun Joon, Moon","Professor","100618800",false,"NCT07336329","Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use","Effectiveness of Periodic Use of Continuous Glucose Monitoring After Three Months of Continuous Use in Patients With Non-Insulin-Treated Type 2 Diabetes Patients: A Multicenter, Randomized, Parallel-Group, Open-Label, Non-Inferiority, Investigator-Initiated Trial","PERIODIC-CGM","Inclusion Criteria:\n\n* Adults aged 19 to 80 years at the time of informed consent\n* Adults with type 2 diabetes not using insulin\n* Patients treated with GLP-1 agonist, oral hypoglycemic agents, and\u002For lifestyle modifications\n* Patients who have maintained stable diabetes treatment for at least 3 months without changes\n* HbA1c between 7.5% and 10.0%\n* Willing to wear personal continuous glucose monitoring device (CGM)\n* Willing to install and use CGM-linked app on personal smartphone with continuous access to WIFI or cellular data\n* Able to read and write Korean as judged by investigator\n* Willing to use medically acceptable contraception until end of study (sterile status, intrauterine device, or concurrent use of male\u002Ffemale barrier method with spermicide)\n* Fully informed about the clinical trial and voluntarily consenting to participate\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus\n* Gestational diabetes mellitus\n* History of pancreatectomy\n* Continuous or intermittent insulin therapy for 7 days or more within 3 months\n* Oral or IV steroid treatment within 1 month prior to informed consent\n* Serious infection, surgery (scheduled or history), or severe trauma within 3 months prior to informed consent\n* History of malignancy within 1 year prior to informed consent (except thyroid cancer)\n* On hemodialysis or peritoneal dialysis or eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m2\n* Unable to avoid the following concomitant medications, devices, or treatments during the study: CGM other than study device, X-ray\u002FMRI\u002FCT scans, radiofrequency thermal therapy, implantable devices such as pacemakers, immunosuppressants, steroids, IV vitamin preparations, cancer treatment, hemodialysis\u002Fperitoneal dialysis, insulin therapy\n* Uncontrolled thyroid disease or clinically significant severe endocrine disorders (Cushing's syndrome, pheochromocytoma, etc.)\n* Severe allergic reaction to skin adhesives (e.g., dyspnea, severe rash, edema)\n* Whole blood donation within 60 days, apheresis within 30 days, or blood transfusion within 90 days prior to device application\n* Judged by investigator as unable to handle continuous glucose monitoring device\n* Pregnant or lactating women\n* Planning pregnancy within 1 year\n* Otherwise judged by investigator as inappropriate for participation in this clinical trial","ALL","19 Years","80 Years",{"count":135,"type":136},150,"ESTIMATED","INTERVENTIONAL",[139],"NA","The goal of this clinical trial is to test whether wearing a continuous glucose monitor (CGM) part-time works as well as wearing it full-time in adults with type 2 diabetes who do not use insulin. The main questions it aims to answer are:\n\n* Does wearing CGM part-time (2 weeks per month) control blood sugar as well as wearing it continuously?\n* How do the two wearing patterns compare for blood sugar levels throughout the day, weight, blood pressure, and patient satisfaction?\n\nResearchers will compare part-time CGM use to continuous CGM use to see if part-time use is just as effective for blood sugar control.\n\nAll participants will:\n\n* Wear a CGM device continuously for 3 months to learn how their blood sugar responds to different foods and activities\n* Then be randomly assigned to wear CGM either part-time (2 weeks each month) or continuously for another 3 months\n* Replace the CGM sensor on their arm every 2 weeks\n* Use a smartphone app to track their blood sugar readings\n* Visit the clinic 3 times for blood tests and check-ups\n* Receive education on adjusting diet based on their CGM readings\n* Keep their current diabetes medications unchanged during the study\n\nThe study will last about 6 months total. Participants will use the FreeStyle Libre 2 CGM device, which is already approved for use in people with diabetes.",[142],"Diabetes Mellitus, Type 2",[144,145],"type 2 diabetes","continuous glucose monitoring","2026-01-10",{"date":148,"type":149},"2026-01-13","ACTUAL",{"date":151,"type":149},"2026-01-02",{"date":153,"type":136},"2027-06-30",{"name":5,"class":6},1]