Auto-antibody Dosage from Blood Spots for Diagnosis of Type 1 Diabetes and Celiace Disease

Last updated: February 25, 2025
Sponsor: Meyer Children's Hospital IRCCS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 1

Diabetes Prevention

Celiac Disease

Treatment

Test on blood sample

Test on dried blood sample

Clinical Study ID

NCT06849622
CELDI
  • Ages 2-13
  • All Genders

Study Summary

Early diagnosis of type 1 diabetes and celiac disease is very useful, allows early therapy and prevents deaths from the onset of diabetic ketoacidosis. This is a pilot study on screening of autoantibodies of type 1 diabetes and celiac disease in tuscany patients. The study aims to evaluate the concordance between the screening results obtained using two different matrix (blood drop spots on card and serum) in the search for autoantibodies for celiac disease and for type 1 diabetes. Moreover, it will be evaluated the feasibility and acceptability of the screening on a sample of the population enrolled in the territory through the participation of pediatricians.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients aged 2-13 years

  • Patients with a confirmed diagnosis of type 1 diabetes or celiac disease (positivecontrols) and children who do not have type 1 diabetes or celiac disease orautoantibodies associated with these pathologies (controls)

  • Obtained informed consent

Exclusion

Exclusion Criteria:

  • none

Study Design

Total Participants: 1500
Treatment Group(s): 2
Primary Treatment: Test on blood sample
Phase:
Study Start date:
November 04, 2024
Estimated Completion Date:
March 30, 2026

Connect with a study center

  • Meyer Children's Hospital IRCCS

    Florence, 50139
    Italy

    Active - Recruiting

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