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

NCT06849622 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2025-02-27

No results posted yet for this 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.

Conditions

  • Celiac Disease in Children
  • Diabetes Mellitus, Type I
  • Screening

Interventions

DIAGNOSTIC_TEST

Test on blood sample

The blood sample will be drawn by venipuncture during clinical routine. The serum will be tested for coeliac or diabetes 1 auto-antibodies, using Elisa test.

DIAGNOSTIC_TEST

Test on dried blood sample

A finger prick will be used to collect Dried blood Spot (DBS) on a special card. The eluted blood spot will be tested, for coeliac and diabetes 1 auto-antibodies, using the same method used for serum, and the same cut-offs for positivity and negativity (Elisa tests)

Sponsors & Collaborators

  • Meyer Children's Hospital IRCCS

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-04
Primary Completion
2026-03-30
Completion
2026-03-30

Countries

  • Italy

Study Locations

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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 NCT06849622 on ClinicalTrials.gov