[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591377":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":30,"responsibleParty":50,"collaborators":18,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":18,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":74,"whyStopped":18,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Rabin Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Tandem Mobi Hybrid Closed Loop (HCL) pump","EXPERIMENTAL","Tandem Mobi Hybrid Closed Loop (HCL) pump with an integrated Control-IQ algorithm (CIQ), the Dexcom G7 continuous glucose monitoring sensor (CGM ) and Tandem Mobi Mobile App",[13],"Device: Tandem Mobi Hybrid Closed Loop (HCL) pump",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":18},"DEVICE",[9],null,[20],{"name":21,"affiliation":22,"role":23},"Marie Muller, MD","Schneider Children's Medical Center","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Alona Hamou, Msc","CONTACT","972-545-950277","alonah@clalit.org.il",[31],{"facility":32,"status":18,"city":33,"state":18,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Schneider Children's Medical Center of Israel","Petah Tikva","4920235","Israel","IL",{"type":38,"coordinates":39},"Point",[40,41],34.88747,32.08707,{"lat":41,"lon":40},[44,47],{"name":45,"role":27,"phone":46,"phoneExt":18,"email":29},"Alona Hamou, MSc","972-3-9253282",{"name":48,"role":49,"phone":18,"phoneExt":18,"email":18},"Revital Nimri, MD","SUB_INVESTIGATOR",{"type":51,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100591377","assessing-the-safety-performance-and-user-experience-of-the-tandem-mobi-automated-insulin-delivery-system-among-young-competitive-athletes-in-real-world-settings-100591377",false,"NCT06979635","Assessing the Safety, Performance, and User Experience of the Tandem Mobi Automated Insulin Delivery System Among Young Competitive Athletes in Real-world Settings.","Captain MOBI","Inclusion Criteria:\n\n* Type 1 diabetes (T1D) for at least 6 months\n* 11≤Age≤18 years\n* HbA1c \\\u003C10.0%\n* Current treatment with automated insulin delivery system (AID) or insulin pump for at least 1 month\n* Willing to switch to Tandem Mobi Pump System and Dexcom CGM for the study duration\n* Competitive-level athletes\n\nExclusion Criteria:\n\n* Concomitant disease that influences metabolic control or HbA1c interpretation\n* Individual has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)\n* Use of antidiabetic agents other than insulin\n* Two or more episodes of severe hypoglycemia (hypoglycemia requiring treatment by another person) within the previous 6 months\n* One or more episodes of ketoacidosis requiring hospitalization within 6 months prior to screening\n* Individual has a positive pregnancy screening test","ALL","11 Years","18 Years",{"count":63,"type":64},12,"ESTIMATED","INTERVENTIONAL",[67],"NA","A single arm, interventional study with 12 weeks study phase preceded by a 2-week run in phase, aiming to evaluate the effectiveness and applicability of the Tandem Mobi automated insulin delivery system (Tandem Mobi Pump System) for competitive youth athletes with type 1 diabetes in real-world conditions.",[70],"Type 1 Diabetes",[70,72,73],"Competitive athletes","Hybrid Closed Loop System","NOT_YET_RECRUITING","2025-05-21",{"date":77,"type":78},"2025-05-25","ACTUAL",{"date":80,"type":64},"2025-06",{"date":80,"type":64},{"name":5,"class":6},1]