Standardized Italian netwoRk Enrolling iNdividuals With Islet-Autoantibodies

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.

NCT Number	NCT07503366
Lead Sponsor	Società Italiana di Endocrinologia e Diabetologia Pediatrica Collaborators: Associazione Medici Diabetologi (AMD), Società Italiana di Diabetologia (SID)
Conditions	Type 1 Diabetes (T1D), Autoantibodies, Hyperglycemia, Impaired Glucose Tolerance (Prediabetes)
Enrollment	300 participants
Start Date	2026-05
Primary Completion	2036-04 (estimated)
Study Completion	2036-04 (estimated)
Updated on ClinicalTrials.gov	2026-04-08