[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100434115":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":46,"responsibleParty":61,"collaborators":63,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":42,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":42,"overallStatus":48,"whyStopped":42,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"FreeStyle Libre (CGM) Group","EXPERIMENTAL","Device: FreeStyle Libre (ver 1.0) Education on lifestyle modification",[13],"Device: FreeStyle Libre",{"label":15,"type":16,"description":17,"interventionNames":18},"Self Monitoring of Blood Glucose (SMBG) Group","ACTIVE_COMPARATOR","Device: Blood glucose meter Education on lifestyle modification",[19],"Device: Blood glucose meter",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","FreeStyle Libre","Flash glucose monitoring + Education on lifestyle modification",[9],[27],"Education on lifestyle modification",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Blood glucose meter","Self monitoring of blood glucose + Education on lifestyle modification",[15],[27],[34],{"name":35,"affiliation":5,"role":36},"Young Min Cho, MD, PhD","PRINCIPAL_INVESTIGATOR",[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Hun Jee Choe, MD","CONTACT","82-2-2072-1965",null,"hunjeechoe@snu.ac.kr",{"name":35,"role":40,"phone":41,"phoneExt":42,"email":45},"ymchomd@snu.ac.kr",[47],{"facility":5,"status":48,"city":49,"state":42,"zip":50,"country":51,"countryCode":42,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Seoul","110-744","South Korea",{"type":53,"coordinates":54},"Point",[55,56],126.9784,37.566,{"lat":56,"lon":55},[59],{"name":60,"role":40,"phone":41,"phoneExt":42,"email":45},"Young Min Cho, MD, PHD",{"type":62,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[64,66],{"name":65,"class":6},"Inje University",{"name":67,"class":6},"Kangbuk Samsung Hospital","100434115","patient-driven-lifestyle-modification-using-freestyle-libre-in-type-2-diabetes-patients-100434115",false,"NCT04932928","Patient-Driven Lifestyle Modification Using FreeStyle Libre in Type 2 Diabetes Patients","PDF","Inclusion Criteria:\n\n* Age 19-80\n* Diagnosed with type 2 diabetes mellitus (DM)\n* Uncontrolled type 2 DM: HbA1c 7.0-10.0%\n* Signed informed consent\n\nExclusion Criteria:\n\n* Diagnosed with other types of diabetes mellitus (i.e. Type 1 DM)\n* Use of prandial insulin\n* Change in diabetes medication in the preceding 3 months\n* Pregnant\u002Flactating women\n* Addiction to drugs and alcohol\n* Use of medications that result in drug-induced hyperglycemia (i.e. steroid)\n* Severe liver disease\n* End-stage renal disease (i.e. on dialysis)\n* Unable to wear CGM devices due to dermatologic side effects (i.e. severe burn, inflammation, active skin infection, severe skin reactions, hypertrichosis, etc.)\n* Conditions that impact the stability of HbA1c measurement","ALL","19 Years","80 Years",{"count":79,"type":80},126,"ESTIMATED","INTERVENTIONAL",[83],"NA","We aim to provide medical nutritional therapy to patients with type 2 diabetes who are on oral hypoglycemic agents or on basal insulin only and monitor the glycemic response with flash glucose monitoring or self-monitoring of blood glucose.\n\nSpecifically, this is a randomized, open-label, controlled study where half of the study participants will have FreeStyle Libre device on for 12 weeks and compare the change in glycated hemoglobin (HbA1c) value with the patients in the control group.",[86,87],"Diabetes Mellitus, Type 2","Lifestyle Risk Reduction","2021-06-13",{"date":90,"type":91},"2021-06-21","ACTUAL",{"date":93,"type":91},"2021-03-23",{"date":95,"type":80},"2023-03-23",{"name":5,"class":6},1]