Standardized Italian netwoRk Enrolling iNdividuals With Islet-Autoantibodies

Sponsor
Società Italiana di Endocrinologia e Diabetologia Pediatrica
Study ID
NCT07503366
Status
Not Yet Recruiting

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Conditions

  • Autoantibodies
  • Hyperglycemia
  • Impaired Glucose Tolerance (Prediabetes)
  • Type 1 Diabetes (T1D)

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Mar 31, 2026
Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2036
Completion
Apr 30, 2036

Study Design

Enrollment
300 participants (estimated)

Primary Outcome Measure

Progression to Stage 3 Type 1 Diabetes [ Time Frame: Up to 10 years from baseline for each participant. ]

Central Contacts

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