| Outcome Measures: |
Primary: The development of persistent confirmed multiple beta-cell autoantibodies, development of persistent confirmed multiple beta-cell autoantibodies (defined as confirmed IAA, confirmed GADA, confirmed IA-2A, or confirmed ZnT8A in two consecutive samples, AND a confirmed second antibody from these four antibodies in one sample., elapsed time from treatment assignment (baseline) to first positive sample visit (>2 beta-cell antibodies) in children who develop persistent confirmed multiple beta-cell antibodies. Primary outcome can develop any time up to last study visit at 7.5 yrs|The development of diabetes, OGTT criteria or clinical criteria for diabetes as defined by the American Diabetes Association (ADA)., elapsed time from random treatment assignment (baseline) to the development diabetes (date of diagnosis). This primary outcome measure can develop any time during treatment or follow-up period up to the last study visit at 7.5 years of age | Secondary: Any persistent confirmed beta-cell autoantibody or diabetes, At least one confirmed autoantibody, in two consecutive samples, including GADA, IA-2A, IAA, ZnT8A, or TS7A, or diabetes as defined by the American Diabetes Association (ADA)., elapsed time from treatm. assignm. (baseline) to 1st pos. sample for >1 beta-cell antibody in children who developed persist. confirm. beta-cell antibodies OR diabetes onset, whichever is first. outcome can develop any time up to last visit at 7.5 yr|Persistent confirmed IAA., Confirmed IAA in two consecutive samples., elapsed time from treatment assignment (baseline) to first sample that is positive for IAA in children who develop persistent confirmed IAA. Outcome can develop any time during treatment or follow-up period up to the last study visit at 7.5 years of age.|Persistent confirmed GADA., Confirmed GADA in two consecutive samples., elapsed time from treatment assignment (baseline) to the first sample that is positive for GADA in children who develop persistent confirmed GADA. Outcome can develop any time up to the last study visit at 7.5 years of age|Abnormal glucose tolerance (AGT) defined by dysglycemia or diabetes., Dysglycemia is defined as impaired fasting plasma glucose of ≥110 mg/dL (6.1 mmol/L), or impaired 2-hour glucose of ≥140 mg/dL (7.8 mmol/L), or high glucose levels at intermediate time points on OGTT (30, 60, 90 min) levels of ≥200mg/dL (11.1 mmol/L)). Diabetes is defined according to the criteria of the American Diabetes Association (ADA)., elapsed time from treatment assignment to the date at which abnormal glucose tolerance or diabetes is diagnosed. Outcome can develop any time up to the last study visit at 7.5 years of age
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| Locations: |
University Hospitals Leuven, Faculty of Medicine, Catholic University of Leuven, Leuven, Belgium, Leuven, 3000, Belgium|Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Munich, Germany, Munich, Bavaria, 80804, Germany|AUF DER BULT, Kinder- und Jugendkrankenhaus, Hanover, Germany, Hanover, Lower Saxony, 30173, Germany|Klinik und Poliklinik f. Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, CRTD/DFG-Forschungszentrum für Regenerative Therapien, Dresden, Germany, Dresden, Saxony, 01307, Germany|Medical University of Warsaw, Department of Paediatrics, Warsaw, Poland, Warsaw, 00-001, Poland|Lund University Dep. of Clinical Sciences Malmo, Skane University Hospital SUS, University Hospital MAS, Malmo, Sweden, Malmö, 202 13, Sweden|Department of Paediatrics Clinical Vaccine Research and Immunisation Education, Children's Hospital, Headington, Oxford, UK, Oxford, OX3 9DU, United Kingdom
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