[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545472":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":28,"locations":39,"responsibleParty":57,"collaborators":10,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":10,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":42,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University Hospital, Motol","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Study group",null,"Type 1 diabetes patients with insulin pump MiniMed 780 G +CGM (continuous glucose monitoring)",[13],"Device: MiniMed 780 G",{"label":15,"type":10,"description":16,"interventionNames":10},"Control group","Type 1 diabetes patients with patients treated by multiple daily injections (MDI) + CGM",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"DEVICE","MiniMed 780 G","none, observational study",[9],[24],{"name":25,"affiliation":26,"role":27},"Jan Brož, MUDr., Ph.D.","Second Medical Faculty, Charles University","PRINCIPAL_INVESTIGATOR",[29,35],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Eva Al Jamal, Mgr.","CONTACT","224 431 017","+420","eva.aljamal@fnmotol.cz",{"name":36,"role":31,"phone":37,"phoneExt":33,"email":38},"Veronika Šourková","224 431 004","veronika.sourkova@fnmotol.cz",[40],{"facility":41,"status":42,"city":43,"state":10,"zip":44,"country":45,"countryCode":10,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"UH Motol","RECRUITING","Prague","150 00","Czechia",{"type":47,"coordinates":48},"Point",[49,50],14.42076,50.08804,{"lat":50,"lon":49},[53,54,55],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},{"name":36,"role":31,"phone":37,"phoneExt":33,"email":38},{"name":56,"role":27,"phone":10,"phoneExt":10,"email":10},"Pavlina Krollova, M.D.",{"type":27,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Jan Broz","Principal Investigator","100545472","glycemic-excursions-in-patients-with-type-1-diabetes-mellitus-using-closed-loop-systems-100545472",false,"NCT06382350","Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems","Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems (Insulin Pump and Continuous Glucose Monitor) Versus Conventional Treatment in Different Life Situations - an Observational Multicenter Study","SAFEDRIVE","Inclusion criteria\n\nStudy group:\n\n* type 1 diabetes\n* patients aged ≥18 year\n* diabetes duration ≥3 years\n* regularly driving (non-professional drivers only)\n* treated with insulin pump MiniMed 780 G for at least 6 months with closed-loop setting treatment\n* willing to fill in the study questionnaires\n* signed patient's informed consent form\n\nControl group:\n\n* type 1 diabetes\n* patients aged ≥18 years\n* diabetes duration ≥3 years\n* regularly driving (non-professional drivers only)\n* treatment with multiple daily injections (MDI) of insulin therapy and the use of CGM for at least 6 months\n* willing to fill in the study questionnaires\n* signed patient's informed consent form\n\nExclusion Criteria (for study and control groups)\n\n* professional drivers\n* pregnancy\n* inability to be present at the follow-up visit\n* inability to complete the study questionnaires\n* participation in another clinical study within the last 3 months","ALL","18 Years",{"count":71,"type":72},120,"ESTIMATED","OBSERVATIONAL","The study aims to compare glycemic excursions during several life situations (such as periods of driving, periods of night sleep, periods of occupation, periods of physical activity, and periods of stress) in patients with type 1 diabetes treated with closed-loop system and multiple daily insulin dose therapy",[76,77,78],"Type 1 Diabetes Mellitus","Type 1 Diabetes Mellitus With Hypoglycemia","Drive",[80,81,82],"Type 1 diabetes mellitus","Driving","Closed-loop system","2024-06-02",{"date":85,"type":86},"2024-06-04","ACTUAL",{"date":88,"type":86},"2024-05-29",{"date":90,"type":72},"2026-05",{"name":5,"class":6},1]