[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Società Italiana di Endocrinologia e Diabetologia Pediatrica\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":56},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":28,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100631644","standardized-italian-network-enrolling-individuals-with-islet-autoantibodies-100631644",false,"NCT07503366","Standardized Italian netwoRk Enrolling iNdividuals With Islet-Autoantibodies","Standardized Italian netwoRk Enrolling iNdividuals With Islet-Autoantibodies (SIRENA)","SIRENA","Inclusion Criteria:\n\n* Individuals of any age who test positive for at least one islet autoantibody.\n* Absence of clinical symptoms of diabetes.\n* Do not meet ADA diagnostic criteria for diabetes (no overt hyperglycemia).\n* Ability to comply with follow-up procedures according to clinical practice.\n* Written informed consent obtained from the participant or, for minors, from a parent or legal guardian.\n\nExclusion Criteria:\n\n* Prior diagnosis of type 1 or type 2 diabetes.\n* Fasting plasma glucose ≥126 mg\u002FdL, HbA1c ≥6.5%, or OGTT 2-hour glucose ≥200 mg\u002FdL.\n* Presence of symptoms suggestive of diabetes (e.g., polyuria, polydipsia, unexplained weight loss, fatigue, visual disturbances, acetone breath, Kussmaul respiration).\n* Any medical or psychological condition judged by the investigator to interfere with study participation or data reliability.\n* Inability or unwillingness to provide informed consent.","ALL",{"count":19,"type":20},300,"ESTIMATED","OBSERVATIONAL","This project characterizes the longitudinal progression of children and adults who have tested positive for one or more islet cell autoantibodies across the early stages of type 1 diabetes (T1D). Despite advances in screening, limited evidence exists on how clinical, metabolic, and immunological markers evolve over time and predict progression to symptomatic disease. Using a screened cohort, participants are followed for up to 10 years with repeated standardized assessments. The study evaluates whether population-based screening can reduce diabetic ketoacidosis (DKA) at diagnosis and identify early predictors of progression to clinical T1D. Results are expected to improve risk stratification, inform surveillance strategies, and guide the timing of preventive interventions, with implications for clinical practice and health policy.",[24,25,26,27],"Type 1 Diabetes (T1D)","Autoantibodies","Hyperglycemia","Impaired Glucose Tolerance (Prediabetes)",[29,25,30,31,26,32,33,34,35,36,37,38,39,40,41,42],"Diabetes Mellitus, Type 1","Islets of Langerhans","Autoimmune Diseases","Impaired Glucose Tolerance","C-Peptide","Oral Glucose Tolerance Test","Continuous Glucose Monitoring","Psychological Stress","Early Diagnosis","Disease Progression","Presymptomatic Type 1 Diabetes","Type 1 Diabetes Stage 1","Type 1 Diabetes Stage 2","Type 1 Diabetes Stage 3","NOT_YET_RECRUITING","2026-04-02",{"date":46,"type":47},"2026-04-08","ACTUAL",{"date":49,"type":20},"2026-05",{"date":51,"type":20},"2036-04",{"name":53,"class":54},"Società Italiana di Endocrinologia e Diabetologia Pediatrica","OTHER",24,""]