[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522331":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":26,"studyPopulation":27,"armGroups":28,"interventions":34,"overallOfficials":40,"centralContacts":44,"locations":53,"responsibleParty":70,"collaborators":23,"id":72,"slug":23,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":23,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":23,"studyType":84,"phases":23,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":56,"whyStopped":23,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Third Affiliated Hospital, Sun Yat-Sen University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"proportion of time spent in the target glucose range","time in range(TIR, 70-180mg\u002FdL)","baseline(at least 2 weeks before the start of APS), and 3 months,6 months, 9 months, 12 months, and following period after the start of APS",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"proportion of time spent in the hypoglycemic range","time below range(TBR, \\\u003C70mg\u002FdL;\\\u003C54mg\u002FdL)",{"measure":18,"description":19,"timeFrame":12},"proportion of time spent in the hyperglycemic range","time above range(TAR, \\>180mg\u002FdL;\\>250mg\u002FdL)",{"measure":21,"description":22,"timeFrame":12},"concentration of HbA1c","glycated hemoglobin A1C",null,{"allocation":23,"interventionModel":23,"interventionModelDescription":23,"primaryPurpose":23,"observationalModel":25,"timePerspective":6,"maskingInfo":23},"COHORT","This is a real-world observational study analyzing data on open-source artificial pancreas systems(APS) in people with T1DM in China. Data will collected during clinical routine, questionnaires, standard-of-care laboratory tests, and CGM data among whom are willing to share. Baseline data from before the start (up to -3 months) of the open-source APS system and follow-up data at 3, 6, 9, 12, and the following period will be analyzed when available. There are no medical interventions, extra visits, or laboratory tests planned outside the normal clinical routine. Glycemic control and patient-reported outcomes during follow-up will be compared with glycemic control and patient-reported outcome data at baseline.","people with T1DM regardless of age or pregnant state.",[29],{"label":30,"type":23,"description":31,"interventionNames":32},"open-source APS","open-source APS consisted of an insulin pump, a CGM system, and a heuristic algorithm on an Android smartphone.",[33],"Device: open-source APS;",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":23},"DEVICE","open-source APS;","a continuous glucose monitoring system, an insulin pump, and an intelligent algorithm.",[30],[41],{"name":42,"affiliation":5,"role":43},"Jinhua Yan, PHD,MD","PRINCIPAL_INVESTIGATOR",[45,49],{"name":42,"role":46,"phone":47,"phoneExt":23,"email":48},"CONTACT","+8613929589959","yanjh79@163.com",{"name":50,"role":46,"phone":51,"phoneExt":23,"email":52},"Wen Xu, PHD,MD","02085253000","xwen@mail.sysu.edu.cn",[54],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Jinhua Yan","RECRUITING","Guangzhou","Guangdong","510630","China","CN",{"type":63,"coordinates":64},"Point",[65,66],113.25,23.11667,{"lat":66,"lon":65},[69],{"name":55,"role":46,"phone":47,"phoneExt":23,"email":48},{"type":43,"investigatorFullName":55,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Vice Professor,Principal Investigator,Department of Endocrinology and Metabolism","100522331",false,"NCT06081231","Open-Source Artificial Pancreas System Use Among People With Type 1 Diabetes Mellitus in China","The Safety and Efficacy of Open-Source Artificial Pancreas System Among People With Type 1 Diabetes Mellitus in China","Inclusion Criteria:\n\n1. diagnosed T1DM.\n2. Currently use open-source APS for at least 3 months.\n3. Willing and able to provide informed consent (or be a parent or other legally authorized representative) and to provide the data.\n4. reside in China.\n\nExclusion Criteria:\n\nNone","ALL","3 Years","75 Years",{"count":82,"type":83},500,"ESTIMATED","OBSERVATIONAL","This real-world observational study aims to reveal the current status of the open-source artificial pancreas system (APS) use among people with T1DM in China and assess the glycemic efficacy and potential related factors of the open-source APS.",[87],"Type 1 Diabetes Mellitus",[89,90,91,92,93],"artificial pancreas system","automated insulin delivery","do-it-yourself","closed loop","open source","2024-06-20",{"date":96,"type":97},"2024-06-24","ACTUAL",{"date":99,"type":97},"2019-01-01",{"date":101,"type":83},"2026-06-01",{"name":5,"class":6},1]