[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636348":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":10,"responsibleParty":21,"collaborators":10,"id":25,"slug":26,"hasResults":27,"nctId":28,"briefTitle":29,"officialTitle":29,"acronym":10,"eligibilityCriteria":30,"healthyVolunteers":31,"sex":32,"minAge":33,"maxAge":34,"enrollmentInfo":35,"targetDuration":10,"studyType":38,"phases":10,"briefSummary":39,"conditions":40,"keywords":10,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":10},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Group A : diabetes mellitus group",null,"Group A1 (patients with β cell dysfunction monogenic diabetes): 60 cases; Group A2 (patients with type 2 diabetes mellitus): 60 cases",{"label":13,"type":10,"description":14,"interventionNames":10},"Group B : normal glucose tolerance group","Group B1 (normal glucose tolerance with fasting \u002F postprandial hyperinsulinemia): 60 cases; Group B2 (normal glucose tolerance with normal insulin levels): 60 cases",[16],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Qian Ren, Doctorate","CONTACT","010-88324371","qianren_xuan@126.com",{"type":22,"investigatorFullName":23,"investigatorTitle":24,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Ren qian","Chief Physician,Professor","100636348","application-of-freestyle-libre-2-for-evaluating-glycemic-variability-characteristics-in-patients-with-extreme-glucose-metabolism-phenotypes-100636348",false,"NCT07564518","Application of FreeStyle Libre 2 for Evaluating Glycemic Variability Characteristics in Patients With Extreme Glucose Metabolism Phenotypes","1. Inclusion Criteria:\n\n   1. Group A1:\n\n      * Age ≥ 18 years;\n      * Patients with β cell dysfunction monogenic diabetes confirmed by DNA sequencing or other diagnostic testing.\n   2. Group A2:\n\n      * Age ≥ 18 years;\n      * Patients with confirmed type 2 diabetes mellitus;\n      * Derived from this center's existing continuous glucose monitoring (CGM) database.\n   3. Group B1:\n\n      * Age ≥ 18 years;\n      * Normal fasting plasma glucose (≥ 3.6 and \\\u003C 6.1 mmol\u002FL) and normal 2-hour plasma glucose during OGTT (≥ 3 and \\\u003C 7.8 mmol\u002FL);\n      * Fasting insulin ≥ 25 µU\u002FmL and\u002For 2-hour insulin during OGTT greater than 10 times the fasting insulin level.\n   4. Group B2:\n\n      * Age ≥ 18 years;\n      * Normal glucose tolerance meeting the 2024 ADA criteria: fasting plasma glucose \\\u003C 5.6 mmol\u002FL, 2-hour plasma glucose during OGTT \\\u003C 7.8 mmol\u002FL;\n      * According to laboratory reference standards, fasting insulin ≥ 2.6 and \\\u003C 25 µU\u002FmL, and 2-hour insulin during OGTT 5-10 times the fasting insulin level.\n      * Derived from this center's existing continuous glucose monitoring (CGM) database.\n2. Exclusion Criteria:\n\n   1. Neonates younger than 4 months of age (congenital diabetes);\n   2. Pregnancy;\n   3. Patients with positive pancreatic autoantibody test results;\n   4. Patients with severe cardiovascular or cerebrovascular diseases, hepatic disease, or renal disease;\n   5. Patients who have participated in other clinical trials.",true,"ALL","18 Years","75 Years",{"count":36,"type":37},120,"ESTIMATED","OBSERVATIONAL","This cross-sectional study aims to further subdivide diabetes mellitus into more homogeneous subgroups by focusing on extreme glucose metabolism phenotypes, including monogenic diabetes with β cell dysfunction, hyperinsulinemia caused by excessive β cell secretion, and postprandial hypoglycemia phenotypes. By utilizing continuous glucose monitoring (CGM) technology and the FreeStyle Libre 2 glucose monitoring device, this study will evaluate glycemic variability patterns in patients with extreme glucose metabolism phenotypes and perform comparative analyses using existing CGM data from healthy populations and patients with type 2 diabetes in our center's database. The study aims to address current gaps in understanding glycemic variability characteristics under extreme β cell functional states, provide novel dynamic monitoring evidence to support early identification, precise classification, and personalized management of these special metabolic states, and simultaneously screen for biomarkers to enable more accurate disease identification, thereby offering potential avenues for improving personalized treatment of diabetes mellitus.",[41,42],"Monogenic Diabetes","Hyperinsulinemia","NOT_YET_RECRUITING","2026-05-31",{"date":46,"type":47},"2026-06-02","ACTUAL",{"date":49,"type":37},"2026-05-25",{"date":51,"type":37},"2027-01-09",{"name":5,"class":6}]