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Standardized Italian netwoRk Enrolling iNdividuals With Islet-Autoantibodies

NCT07503366 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-04-08

No results posted yet for this study

Summary

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.

Conditions

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

Sponsors & Collaborators

  • Associazione Medici Diabetologi (AMD)

    collaborator UNKNOWN

  • Società Italiana di Diabetologia (SID)

    collaborator UNKNOWN

  • Società Italiana di Endocrinologia e Diabetologia Pediatrica

    lead OTHER

Principal Investigators

  • Valentino Cherubini · SOD Diabetologia Pediatrica - Azienda Ospedaliero Universitaria delle Marche, Ancona, Italy

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2036-04-30
Completion
2036-04-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07503366 on ClinicalTrials.gov