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

Not Applicable

Recruiting

• Conditions: Screening; Celiac Disease in Children; Diabetes Mellitus, Type I

• Registration Number: NCT06849622
• Lead Sponsor: Meyer Children's Hospital IRCCS

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-04
• Status Verified: 2025-02
• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-25
• Last Update Submitted: 2025-02-25
• Study First Posted: 2025-02-27
• Last Update Posted: 2025-02-27
• Primary Completion: 2026-03-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Patients aged 2-13 years
• Patients with a confirmed diagnosis of type 1 diabetes or celiac disease (positive controls) and children who do not have type 1 diabetes or celiac disease or autoantibodies associated with these pathologies (controls)
• Obtained informed consent

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparability between spot and serum tests of the following parameters tissue transglutaminase Immunoglobuline A (tTg IgA) test, reference values <16 Units/ml	Baseline

Secondary Outcome Measures

Name	Time	Method
Comparability between spot and serum tests of the following parameters: anti-insulin antibodies (IAA) test, reference values <10 Units/ml	Baseline
Comparability between spot and serum tests of the following parameter glutamic acid decarboxylase antibodies (GAD-65) test, reference values <5.5Units/ml	Baseline
Antibody titers (Units/ml) for coeliac disease autoantibodies and type 1 diabetes	Baseline
Comparability between spot and serum tests of the following parameters: protein tyrosine phosphatase antibodies (IA2) test, reference values <7.5 Units/ml	Baseline
Comparability between spot and serum tests of the following parameter zinc transporter 8 (ZnT8) test, reference values <15Units/ml	Baseline

Trial Locations

Locations (1)

Meyer Children's Hospital IRCCS; 🇮🇹 Florence, Italy