Actively Recruiting

Phase Not Applicable
Age: 2Years - 13Years
All Genders
NCT06849622

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

Led by Meyer Children's Hospital IRCCS · Updated on 2025-02-27

1500

Participants Needed

1

Research Sites

73 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 2Years - 13Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

Meyer Children's Hospital IRCCS

Florence, Italy, Italy, 50139

Actively Recruiting

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Research Team

C

Chiara Azzari

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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