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

Meyer Children's Hospital IRCCS

Status: Enrolling

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

Treatments: Diagnostic Test: Test on dried blood sample; Diagnostic Test: Test on blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT06849622

CELDI

Details and patient eligibility

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 2 to 13 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups

Test on blood sample (diagnosis of celiac and diabetes disease)

Other group

Treatment:

Diagnostic Test: Test on blood sample

test on dried blood spot (celiac and diabetes patients)

Other group

Treatment:

Diagnostic Test: Test on dried blood sample