[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628126":3},{"organization":4,"outcomesModule":7,"designInfo":59,"detailedDescription":32,"studyPopulation":62,"armGroups":63,"interventions":68,"overallOfficials":32,"centralContacts":74,"locations":81,"responsibleParty":216,"collaborators":32,"id":218,"slug":219,"hasResults":220,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":32,"eligibilityCriteria":224,"healthyVolunteers":220,"sex":225,"minAge":32,"maxAge":32,"enrollmentInfo":226,"targetDuration":32,"studyType":229,"phases":32,"briefSummary":230,"conditions":231,"keywords":32,"overallStatus":84,"whyStopped":32,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":242},{"fullName":5,"class":6},"Sanofi","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":32},[9,13,16,19,21],{"measure":10,"description":11,"timeFrame":12},"Participant demographics at teplizumab initiation","Age, sex at birth, height, weight, Body mass index (BMI), body surface area","At Day 1 (first dose of teplizumab)",{"measure":14,"description":15,"timeFrame":12},"Participants' family history of T1D and autoimmune diseases","First- and second-degree relatives with T1D",{"measure":17,"description":18,"timeFrame":12},"Presence of T1D susceptibility genes","Genetic risk score",{"measure":17,"description":20,"timeFrame":12},"Human Leukocyte Antigen (HLA)-haplotype",{"measure":22,"description":23,"timeFrame":24},"Participants' medical history","Date of stage 1 confirmation, date of dysglycemia confirmation","From 6 months prior to the first dose of teplizumab (teplizumab initiation) (or the earliest date of all data contributing to Stage 2 T1D diagnosis, whichever is earlier) up to medical records abstraction date, approximately 3-4 years",[26,30,34,37,39,41,43,45,47,49,52,55,57],{"measure":27,"description":28,"timeFrame":29},"Time from Stage 1 T1D confirmation to Stage 2 confirmation","Only participants with a date of Stage 1 T1D confirmation will be included in this analysis.","From the date of Stage 1 T1D confirmation to date of first assessment of dysglycemia or positive autoantibody test up to date of first dose of teplizumab (teplizumab initiation), approximately 6 months to a year",{"measure":31,"description":32,"timeFrame":33},"Time from Stage 2 T1D confirmation to teplizumab initiation",null,"From the date of first assessment of dysglycemia or positive autoantibody test up to date of first dose of teplizumab (teplizumab initiation), approximately 6 months to a year",{"measure":35,"description":32,"timeFrame":36},"Assessment of blood glucose test results: Glycated hemoglobin (HbA1c)","At screening (6 months before teplizumab initiation), within 6 weeks prior to teplizumab initiation, during teplizumab infusion (2 weeks), following completion of teplizumab treatment (through study completion, up to 30 months)",{"measure":38,"description":32,"timeFrame":36},"Assessment of blood glucose test results: Fasting Plasma Glucose (FPG)",{"measure":40,"description":32,"timeFrame":36},"Assessment of blood glucose test results: Oral Glucose Tolerance Test (OGTT)",{"measure":42,"description":32,"timeFrame":36},"Assessment of blood glucose test results: Random Plasma Glucose (PG)",{"measure":44,"description":32,"timeFrame":36},"Assessment of blood glucose test results: Post-prandial Glucose (PPG)",{"measure":46,"description":32,"timeFrame":36},"Assessment of blood glucose test results: Continuous glucose monitoring (CGM)",{"measure":48,"description":32,"timeFrame":36},"Assessment of C-peptide test results",{"measure":50,"description":51,"timeFrame":36},"Assessment of autoantibody test results","Anti-GAD65, IAA, Anti-IA-2, ICA, Anti-ZnT8",{"measure":53,"description":32,"timeFrame":54},"Proportion of participants who complete teplizumab treatment course","At Day 1 (first dose of teplizumab) until end of follow-up, up to 24 months",{"measure":56,"description":32,"timeFrame":54},"Proportion of participants using insulin during the study period",{"measure":58,"description":32,"timeFrame":54},"Proportion of participants using other glucose lowering therapies during the study period",{"allocation":32,"interventionModel":32,"interventionModelDescription":32,"primaryPurpose":32,"observationalModel":60,"timePerspective":61,"maskingInfo":32},"COHORT","RETROSPECTIVE","Patients diagnosed with Stage 2 T1D who have received at least 1 teplizumab infusion within 6 weeks prior to enrollment. Approximately 60 participants, in approximately 15 sites across at least 5 countries will be enrolled.",[64],{"label":65,"type":32,"description":32,"interventionNames":66},"Patients with Stage 2 Type 1 Diabetes (T1D) who received Teplizumab",[67],"Drug: Teplizumab",[69],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":32},"DRUG","Teplizumab","This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.",[65],[75],{"name":76,"role":77,"phone":78,"phoneExt":79,"email":80},"Trial Transparency email recommended (Toll free for US & Canada)","CONTACT","800-633-1610","Option 6","contact-us@sanofi.com",[82,95,106,115,121,132,141,152,161,170,181,187,196,207],{"facility":83,"status":84,"city":85,"state":32,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":32},"Investigational Site Number: 0560001","RECRUITING","Leuven","3000","Belgium","BE",{"type":90,"coordinates":91},"Point",[92,93],4.70093,50.87959,{"lat":93,"lon":92},{"facility":96,"status":84,"city":97,"state":32,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":105,"contacts":32},"Investigational Site Number: 2500001","Bron","69677","France","FR",{"type":90,"coordinates":102},[103,104],4.91303,45.73865,{"lat":104,"lon":103},{"facility":107,"status":84,"city":108,"state":32,"zip":109,"country":99,"countryCode":100,"cosmosGeoPoint":110,"geoPoint":114,"contacts":32},"Investigational Site Number: 2500003","Paris","75014",{"type":90,"coordinates":111},[112,113],2.3488,48.85341,{"lat":113,"lon":112},{"facility":116,"status":84,"city":108,"state":32,"zip":117,"country":99,"countryCode":100,"cosmosGeoPoint":118,"geoPoint":120,"contacts":32},"Investigational Site Number: 2500002","75015",{"type":90,"coordinates":119},[112,113],{"lat":113,"lon":112},{"facility":122,"status":84,"city":123,"state":32,"zip":124,"country":125,"countryCode":126,"cosmosGeoPoint":127,"geoPoint":131,"contacts":32},"Investigational Site Number: 2760002","Frankfurt","60596","Germany","DE",{"type":90,"coordinates":128},[129,130],10.53333,49.68333,{"lat":130,"lon":129},{"facility":133,"status":84,"city":134,"state":32,"zip":135,"country":125,"countryCode":126,"cosmosGeoPoint":136,"geoPoint":140,"contacts":32},"Investigational Site Number: 2760001","Hanover","30173",{"type":90,"coordinates":137},[138,139],9.73322,52.37052,{"lat":139,"lon":138},{"facility":142,"status":84,"city":143,"state":32,"zip":144,"country":145,"countryCode":146,"cosmosGeoPoint":147,"geoPoint":151,"contacts":32},"Investigational Site Number: 3800001","Ancona","60123","Italy","IT",{"type":90,"coordinates":148},[149,150],13.5103,43.60717,{"lat":150,"lon":149},{"facility":153,"status":84,"city":154,"state":32,"zip":155,"country":145,"countryCode":146,"cosmosGeoPoint":156,"geoPoint":160,"contacts":32},"Investigational Site Number: 3800003","Palermo","90127",{"type":90,"coordinates":157},[158,159],13.3636,38.1166,{"lat":159,"lon":158},{"facility":162,"status":84,"city":163,"state":32,"zip":164,"country":145,"countryCode":146,"cosmosGeoPoint":165,"geoPoint":169,"contacts":32},"Investigational Site Number: 3800002","Verona","37126",{"type":90,"coordinates":166},[167,168],10.9938,45.43854,{"lat":168,"lon":167},{"facility":171,"status":84,"city":172,"state":32,"zip":173,"country":174,"countryCode":175,"cosmosGeoPoint":176,"geoPoint":180,"contacts":32},"Investigational Site Number: 7240001","Madrid","28034","Spain","ES",{"type":90,"coordinates":177},[178,179],-3.70256,40.4165,{"lat":179,"lon":178},{"facility":182,"status":84,"city":172,"state":32,"zip":183,"country":174,"countryCode":175,"cosmosGeoPoint":184,"geoPoint":186,"contacts":32},"Investigational Site Number: 7240002","28046",{"type":90,"coordinates":185},[178,179],{"lat":179,"lon":178},{"facility":188,"status":84,"city":189,"state":32,"zip":190,"country":174,"countryCode":175,"cosmosGeoPoint":191,"geoPoint":195,"contacts":32},"Investigational Site Number: 7240003","Zaragoza","50009",{"type":90,"coordinates":192},[193,194],-0.87734,41.65606,{"lat":194,"lon":193},{"facility":197,"status":84,"city":198,"state":32,"zip":199,"country":200,"countryCode":201,"cosmosGeoPoint":202,"geoPoint":206,"contacts":32},"Investigational Site Number: 8260001","Birmingham","B4 6NH","United Kingdom","UK",{"type":90,"coordinates":203},[204,205],-1.89983,52.48142,{"lat":205,"lon":204},{"facility":208,"status":84,"city":209,"state":32,"zip":210,"country":200,"countryCode":201,"cosmosGeoPoint":211,"geoPoint":215,"contacts":32},"Investigational Site Number: 8260002","London","E1 1BB",{"type":90,"coordinates":212},[213,214],-0.12574,51.50853,{"lat":214,"lon":213},{"type":217,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100628126","real-world-study-of-patients-with-type-1-diabetes-treated-with-teplizumab-as-part-of-managed-access-programs-maps-100628126",false,"NCT07457580","Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)","A Real-World Retrospective Observational Study Characterizing Patients With Stage 2 Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)","Inclusion Criteria:\n\n* Patient written or electronic informed consent or assent (for patients \\\u003C 18 years old) according to local regulations or appropriate informed consent waivers prior to any study related activity.\n* Patient received ≥ 1 day of teplizumab treatment as part of MAPs.\n\nExclusion Criteria:\n\n• Participation in an interventional clinical study on the index date. Participation in an interventional clinical study is defined as initiating the product\u002Fprocedure or control under investigation. An interventional clinical study is a study that requires deviation from standard clinical practice by following a study protocol.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","ALL",{"count":227,"type":228},60,"ESTIMATED","OBSERVATIONAL","This study is a multi-country, multi-center retrospective observational cohort study based on secondary data collected via chart review, with the aim of describing patient characteristics (including relevant comorbidities), monitoring and treatment practices related to Type 1 diabetes mellitus (T1D) progression, and time to T1D progression in participants who received teplizumab as part of Managed Access Programs (MAPs). This study design was chosen in order to gain rapid insight into the current use of teplizumab in clinical practice and the characteristics of patients who received the treatment.",[232],"Type 1 Diabetes","2026-08-25",{"date":235,"type":236},"2026-08-26","ACTUAL",{"date":238,"type":236},"2026-03-16",{"date":240,"type":228},"2026-11-30",{"name":5,"class":6},14]