About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Locations

24
SOD Diabetologia Pediatrica - Azienda Ospedaliero Universitaria delle Marche Ancona Italy
Ambulatorio di Diabetologia Pediatrica, UOC Pediatria/Neonatologia Ospedale San Paolo Bari Italy
Department of Pediatrics, Hospital of Bolzano (SABES-ASDAA),Teaching Hospital of Paracelsus Medical University Bolzano Italy
UOS Diabetologia ed Endocrinologia pediatrica, AORN Sant'Anna e San Sebastiano Caserta Italy

Sponsors and collaborators

Società Italiana di Endocrinologia e Diabetologia Pediatrica

Lead sponsor

Associazione Medici Diabetologi (AMD)

Collaborator

Società Italiana di Diabetologia (SID)

Collaborator