[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620627":3},{"organization":4,"outcomesModule":7,"designInfo":85,"detailedDescription":88,"studyPopulation":89,"armGroups":90,"interventions":95,"overallOfficials":11,"centralContacts":101,"locations":108,"responsibleParty":198,"collaborators":11,"id":200,"slug":201,"hasResults":202,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":202,"sex":208,"minAge":11,"maxAge":11,"enrollmentInfo":209,"targetDuration":11,"studyType":212,"phases":11,"briefSummary":213,"conditions":214,"keywords":11,"overallStatus":111,"whyStopped":11,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":225},{"fullName":5,"class":6},"Sanofi","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Time from teplizumab infusion start to the onset of Stage 3 T1D",null,"From start of infusion to maximum of 10 years",[14,17,20,23,27,30,32,34,36,38,41,44,47,50,53,56,59,61,63,67,69,72,74,76,79,81,83],{"measure":15,"description":11,"timeFrame":16},"Proportion of participants who complete teplizumab treatment course","Up to end of infusion, maximum of 5 years",{"measure":18,"description":11,"timeFrame":19},"Number of participants with adverse events during the infusion period","Till 6 weeks post last infusion, maximum of 5 years",{"measure":21,"description":11,"timeFrame":22},"Number of participants with adverse events of special interest and serious adverse events","From 6 weeks post last infusion through the follow-up, maximum of 10 years",{"measure":24,"description":25,"timeFrame":26},"Number of participants with T1D-related complications","Including but not limited to the following: diabetic ketoacidosis, severe hypoglycemia, retinopathy, nephropathy, neuropathy, cardiovascular events","From infusion up to end of study, maximum of 10 years",{"measure":28,"description":11,"timeFrame":29},"Glycemic control assessment values","From baseline through follow-up, maximum of 10 years",{"measure":31,"description":11,"timeFrame":29},"Change from baseline in glycated hemoglobin (HbA1c)",{"measure":33,"description":11,"timeFrame":29},"Proportion of participants achieving target HbA1c ≤ 6.5%",{"measure":35,"description":11,"timeFrame":29},"Proportion of participants using home glycemic control assessments (eg, SMBG, CGM)",{"measure":37,"description":11,"timeFrame":29},"Proportion of participants using glycemic control assessments in-clinic (eg, OGTT, FPG, MMTT, RPG)",{"measure":39,"description":40,"timeFrame":29},"Mean change from baseline in Time in range (TIR) (70 to 180 mg\u002FdL [3.9 to 10 mmol\u002FL])","CGM reading 70 to 180 mg\u002FdL \\[3.9 to 10 mmol\u002FL\\]",{"measure":42,"description":43,"timeFrame":29},"Mean change from baseline in Time in tight range (TITR) (70 to 140 mg\u002FdL [3.9 to 7.8 mmol\u002FL])","CGM reading 70 to 140 mg\u002FdL \\[3.9 to 7.8 mmol\u002FL\\]",{"measure":45,"description":46,"timeFrame":29},"Mean change from baseline in Time above tight range (TATR): >140 mg\u002FdL (>7.8 mmol\u002FL)","CGM reading \\>140 mg\u002FdL (\\>7.8 mmol\u002FL)",{"measure":48,"description":49,"timeFrame":29},"Mean change from baseline in Time above range (TAR): >180 mg\u002FdL (>10 mmol\u002FL)","CGM reading \\>180 mg\u002FdL (\\>10 mmol\u002FL)",{"measure":51,"description":52,"timeFrame":29},"Mean change from baseline in Time above range (TAR): >250 mg\u002FdL (>13.9 mmol\u002FL)","CGM reading \\>250 mg\u002FdL (\\>13.9 mmol\u002FL)",{"measure":54,"description":55,"timeFrame":29},"Mean change from baseline in Time below range (TBR): \u003C70 mg\u002FdL (\u003C3.9 mmol\u002FL)","CGM reading \\\u003C70 mg\u002FdL (\\\u003C3.9 mmol\u002FL)",{"measure":57,"description":58,"timeFrame":29},"Mean change from baseline in Time below range (TBR): \u003C54 mg\u002FdL (\u003C3.0 mmol\u002FL)","CGM reading \\\u003C54 mg\u002FdL (\\\u003C3.0 mmol\u002FL)",{"measure":60,"description":11,"timeFrame":29},"Mean change from baseline in within-day glucose coefficient of variation",{"measure":62,"description":11,"timeFrame":29},"Mean change from baseline in between-day glucose coefficient of variation",{"measure":64,"description":65,"timeFrame":66},"Proportion of participants using insulin during the study period","Continuous subcutaneous insulin infusion, insulin pump, or pump integrated with an automated insulin delivery system","Up to end of study, maximum of 10 years",{"measure":68,"description":11,"timeFrame":66},"Proportion of participants using other glucose lowering therapies during the study period",{"measure":70,"description":11,"timeFrame":71},"Change in EuroQol 5-Dimensions (EQ-5D) scores in adult and pediatric participants","From the first posttreatment visit after the last teplizumab infusion through follow-up, for a maximum of 10 years",{"measure":73,"description":11,"timeFrame":71},"Change in Hospital Anxiety and Depression Scale (HADS) scores in adult participants",{"measure":75,"description":11,"timeFrame":71},"Change in World Health Organization-Five Well-Being Index (WHO-5) scores in pediatric participants",{"measure":77,"description":11,"timeFrame":78},"Change in Diabetes Distress Scale (DDS) scores in adult participants","From the time of Stage 3 T1D confirmation through follow-up, for a maximum of 10 years",{"measure":80,"description":11,"timeFrame":78},"Change in Hypoglycemia Fear Survey-II (HFS-II) scores in adult and pediatric participants",{"measure":82,"description":11,"timeFrame":66},"Annualized rate of hospitalizations due to T1D related disease and complications",{"measure":84,"description":11,"timeFrame":66},"Annualized rate of emergency room visits related to T1D related disease and complications",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":86,"timePerspective":87,"maskingInfo":11},"COHORT","PROSPECTIVE","Enrolled participants will be followed for up to 10 years depending on the time the participants are included after initiating teplizumab treatment.","Patients diagnosed with Stage 2 T1D who have received at least 1 teplizumab infusion within 6 weeks prior to enrollment. Approximately 1000 participants, in 85 sites across 19 countries will be enrolled over 5 years.",[91],{"label":92,"type":11,"description":11,"interventionNames":93},"Patients with Stage 2 Type 1 Diabetes (T1D) who received Teplizumab",[94],"Drug: Teplizumab",[96],{"type":97,"name":98,"description":99,"armGroupLabels":100,"otherNames":11},"DRUG","Teplizumab","This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.",[92],[102],{"name":103,"role":104,"phone":105,"phoneExt":106,"email":107},"Trial Transparency email recommended (Toll free for US & Canada)","CONTACT","800-633-1610","Option 6","contact-us@sanofi.com",[109,123,129,138,147,157,168,177,183,193],{"facility":110,"status":111,"city":112,"state":113,"zip":114,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":122,"contacts":11},"Investigational Site Number: 8400003","RECRUITING","Atlanta","Georgia","30318-2538","United States","US",{"type":118,"coordinates":119},"Point",[120,121],-84.38798,33.749,{"lat":121,"lon":120},{"facility":124,"status":111,"city":112,"state":113,"zip":125,"country":115,"countryCode":116,"cosmosGeoPoint":126,"geoPoint":128,"contacts":11},"Investigational Site Number: 8400004","30329-3102",{"type":118,"coordinates":127},[120,121],{"lat":121,"lon":120},{"facility":130,"status":111,"city":131,"state":131,"zip":132,"country":115,"countryCode":116,"cosmosGeoPoint":133,"geoPoint":137,"contacts":11},"Investigational Site Number: 8400001","New York","10016",{"type":118,"coordinates":134},[135,136],-74.00597,40.71427,{"lat":136,"lon":135},{"facility":139,"status":111,"city":140,"state":131,"zip":141,"country":115,"countryCode":116,"cosmosGeoPoint":142,"geoPoint":146,"contacts":11},"Investigational Site Number: 8400002","Syosset","11791",{"type":118,"coordinates":143},[144,145],-73.50207,40.82621,{"lat":145,"lon":144},{"facility":148,"status":111,"city":149,"state":150,"zip":151,"country":115,"countryCode":116,"cosmosGeoPoint":152,"geoPoint":156,"contacts":11},"Investigational Site Number: 8400005","Sandy City","Utah","84093",{"type":118,"coordinates":153},[154,155],-111.8841,40.59161,{"lat":155,"lon":154},{"facility":158,"status":111,"city":159,"state":11,"zip":160,"country":161,"countryCode":162,"cosmosGeoPoint":163,"geoPoint":167,"contacts":11},"Investigational Site Number: 3760003","Petah Tikva","4920235","Israel","IL",{"type":118,"coordinates":164},[165,166],34.88747,32.08707,{"lat":166,"lon":165},{"facility":169,"status":111,"city":170,"state":11,"zip":171,"country":161,"countryCode":162,"cosmosGeoPoint":172,"geoPoint":176,"contacts":11},"Investigational Site Number: 3760002","Ramat Gan","52621",{"type":118,"coordinates":173},[174,175],34.81065,32.08227,{"lat":175,"lon":174},{"facility":178,"status":111,"city":170,"state":11,"zip":179,"country":161,"countryCode":162,"cosmosGeoPoint":180,"geoPoint":182,"contacts":11},"Investigational Site Number: 3760001","5265601",{"type":118,"coordinates":181},[174,175],{"lat":175,"lon":174},{"facility":184,"status":111,"city":185,"state":11,"zip":11,"country":186,"countryCode":187,"cosmosGeoPoint":188,"geoPoint":192,"contacts":11},"Investigational Site Number: 7840001","Abu Dhabi","United Arab Emirates","AE",{"type":118,"coordinates":189},[190,191],54.39696,24.45118,{"lat":191,"lon":190},{"facility":194,"status":111,"city":185,"state":11,"zip":11,"country":186,"countryCode":187,"cosmosGeoPoint":195,"geoPoint":197,"contacts":11},"Investigational Site Number: 7840002",{"type":118,"coordinates":196},[190,191],{"lat":191,"lon":190},{"type":199,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100620627","long-term-outcomes-of-teplizumab-in-routine-clinical-care-100620627",false,"NCT07360080","Long-Term Outcomes of Teplizumab in Routine Clinical Care","Long-Term Outcomes of Participants Treated With Teplizumab in Routine Clinical Care","AL1GN","Inclusion Criteria -\n\n* Participants who have received at least 1 teplizumab infusion within 6 weeks prior to enrollment.\n* Participants must have a confirmed diagnosis of Stage 2 T1D according to the treating physician at the time of the first infusion of teplizumab.\n\n(Note: Participants who progress to Stage 3 T1D by Week 6 will still be eligible, provided they were in Stage 2 at the time of the first teplizumab infusion.)\n\n• Participants (or their legal guardians, as applicable) who provide appropriate written or electronic informed consent\u002Fassent as applicable for the age of the participant and as per local regulations.\n\nExclusion Criteria -\n\n* Participants who had participated in a previous clinical trial for teplizumab.\n* Participants enrolled in a clinical trial within 6 months prior to study enrollment.\n\n(Note: Participants enrolled in other observational studies may be included.)\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","ALL",{"count":210,"type":211},1000,"ESTIMATED","OBSERVATIONAL","This is an observational, prospective cohort study designed to evaluate the outcomes after teplizumab treatment in participants with Stage 2 Type 1 Diabetes (T1D) for delaying the onset of Stage 3 T1D. The study will monitor participants receiving teplizumab as part of routine clinical care across multiple sites. Additionally, patient-reported outcomes (PROs) will be evaluated to further assess the treatment's impact on participant's quality of life including emotional and psychosocial aspects associated with T1D. This approach will provide a more comprehensive understanding of how the treatment performs over time and across diverse patient populations, providing valuable insights into the sustained effects of teplizumab and offering a real world picture of its impact on the long-term management of T1D.",[215],"Type 1 Diabetes","2026-08-21",{"date":218,"type":219},"2026-08-25","ACTUAL",{"date":221,"type":219},"2026-03-19",{"date":223,"type":211},"2035-10-29",{"name":5,"class":6},10]