[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603691":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":60,"collaborators":19,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":19,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":19,"enrollmentInfo":70,"targetDuration":19,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":19,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Henan University of Science and Technology","OTHER",[8],{"label":9,"type":10,"description":9,"interventionNames":11},"Adult patients with T1DM","EXPERIMENTAL",[12],"Device: GK5 CGKM",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","GK5 CGKM","Wear for a consecutive 15 days",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Hongwei Jiang","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Peng Liu","CONTACT","0379-64811993","peng.liu87@outlook.com",[31,49],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"The First Hospital of Hebei Medical University","RECRUITING","Shijiazhuang","Hebei","050000","China","CN",{"type":40,"coordinates":41},"Point",[42,43],114.47861,38.04139,{"lat":43,"lon":42},[46],{"name":47,"role":27,"phone":48,"phoneExt":19,"email":19},"Huijuan Ma, MD","0311-87155482",{"facility":5,"status":33,"city":50,"state":51,"zip":52,"country":37,"countryCode":38,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Luoyang","Henan","471003",{"type":40,"coordinates":54},[55,56],112.43684,34.67345,{"lat":56,"lon":55},[59],{"name":26,"role":27,"phone":19,"phoneExt":19,"email":29},{"type":23,"investigatorFullName":26,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Investigator","100603691","safety-and-effectiveness-of-a-novel-continuous-glucose-and-ketone-monitoring-system-100603691",false,"NCT07139808","Safety and Effectiveness of A Novel Continuous Glucose and Ketone Monitoring System","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagonsed with T1DM on Continuous subcutaneous insulin infusion (CSII)\n* Venous blood sampling access can be established in the forearm\n* Capable of independently reading instructions and complying with the clinical trial requirements\n* Willing to sign the Informed Consent Form (ICF)\n\nExclusion Criteria:\n\n* Severe hypoglycemia within the past 6 months\n* A diagnosed history of Diabetic ketoacidosis (DKA) in the past 3 months\n* Heart failure or hemiplegic sequelae due to prior cerebrovascular disease\n* Severe skin conditions at the sensor wear site\n* Extensive systemic skin disorders\n* Having difficulty with wound healing, bleeding disorders, and\u002For taking anticoagulant medications\n* Anemia or abnormal hematocrit\n* Blood donation within the past 6 months\n* Pregnancy (defined as positive urine test in women ≤55 years), lactation, or plans for pregnancy within ≤30 days\n* Current or recent (≤1 month) participation in other clinical trials\n* Planned MRI\u002FCT scans during sensor wear\n* Allergy to medical adhesives or alcohol\n* Conditions impairing comprehension of informed consent or study procedures\n* Other exclusionary conditions per investigator's discretion","ALL","18 Years",{"count":71,"type":72},12,"ESTIMATED","INTERVENTIONAL",[75],"NA","The study is to evaluate the accuracy and safety of a novel real-time continuous glucose and ketone monitoring system among adult patients with type 1 diabetes mellitus (T1DM) with respect to Yellow Spring Instrument (YSI) and Randox reference venous plasma sample measurements.",[78],"Type1diabetes","2026-04-01",{"date":81,"type":82},"2026-04-07","ACTUAL",{"date":84,"type":82},"2025-08-01",{"date":86,"type":72},"2026-12-01",{"name":5,"class":6},2]