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.
Individuals of any age who test positive for at least one islet autoantibody.
Absence of clinical symptoms of diabetes.
Do not meet ADA diagnostic criteria for diabetes (no overt hyperglycemia).
Ability to comply with follow-up procedures according to clinical practice.
Prior diagnosis of type 1 or type 2 diabetes.
Fasting plasma glucose ≥126 mg/dL, HbA1c ≥6.5%, or OGTT 2-hour glucose ≥200 mg/dL.
Presence of symptoms suggestive of diabetes (e.g., polyuria, polydipsia, unexplained weight loss, fatigue, visual disturbances, acetone breath, Kussmaul respiration).
Any medical or psychological condition judged by the investigator to interfere with study participation or data reliability.
The study population includes children, adolescents, and adults who have tested positive for at least one islet cell autoantibody through population-based screening, family screening, routine clinical evaluation, or targeted screening of individuals with autoimmune conditions or incidental dysglycemia. Eligible participants are in the pre-symptomatic stages of T1D, without clinical signs of disease and not meeting diagnostic criteria for diabetes at enrollment. Recruitment occurs at pediatric and adult diabetes centers participating in the national study network. The resulting dataset also provides a resource for future analyses of the clinical and psychological outcomes associated with pre-symptomatic T1D.
Cohort
Prospective
Not listed
Progression to Stage 3 Type 1 Diabetes
Proportion of participants who progress from pre-symptomatic stages (pre-stage 1, stage 1, or stage 2) to clinical stage 3 type 1 diabetes, defined according to ADA diagnostic criteria based on hyperglycemia with or without symptoms. Progression is identified using routine metabolic assessments and clinical evaluation.
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Società Italiana di Endocrinologia e Diabetologia Pediatrica
Lead sponsor
Associazione Medici Diabetologi (AMD)
Collaborator
Società Italiana di Diabetologia (SID)
Collaborator
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