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Clinical Trials in Italy / NCT06849622
Recruiting Not applicable

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

NCT06849622 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-11-04
Last updated
2025-02-27

Condition(s) studied

Celiac Disease in ChildrenDiabetes Mellitus, Type IScreening

Investigational drug(s) / intervention(s)

Test on blood sampleTest on dried blood sample

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.

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)

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

Sex
ALL
Min age
2 Years
Max age
13 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Meyer Children's Hospital IRCCS Florence Italy Recruiting

More Meyer Children's Hospital IRCCS trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06849622 on ClinicalTrials.gov ↗ ← All trials in Italy