[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603691":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":59,"collaborators":19,"id":61,"slug":19,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":19,"eligibilityCriteria":65,"healthyVolunteers":62,"sex":66,"minAge":67,"maxAge":19,"enrollmentInfo":68,"targetDuration":19,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":19,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"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",[31,48],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"The First Hospital of Hebei Medical University","RECRUITING","Shijiazhuang","Hebei","050000","China",{"type":39,"coordinates":40},"Point",[41,42],114.47861,38.04139,{"lat":42,"lon":41},[45],{"name":46,"role":27,"phone":47,"phoneExt":19,"email":19},"Huijuan Ma, MD","0311-87155482",{"facility":5,"status":33,"city":49,"state":50,"zip":51,"country":37,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Luoyang","Henan","471003",{"type":39,"coordinates":53},[54,55],112.43684,34.67345,{"lat":55,"lon":54},[58],{"name":26,"role":27,"phone":19,"phoneExt":19,"email":29},{"type":23,"investigatorFullName":26,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Investigator","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":69,"type":70},12,"ESTIMATED","INTERVENTIONAL",[73],"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.",[76],"Type1diabetes","2026-04-01",{"date":79,"type":80},"2026-04-07","ACTUAL",{"date":82,"type":80},"2025-08-01",{"date":84,"type":70},"2026-12-01",{"name":5,"class":6},2]