RecruitingNot ApplicableNCT06849622

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

Sponsor

Meyer Children's Hospital IRCCS

Enrollment

1,500 participants

Start Date

Nov 4, 2024

Study Type

INTERVENTIONAL

Conditions

Screening Celiac Disease in Children Diabetes Mellitus, Type I

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

Min Age: 2 YearsMax Age: 13 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a simple dried blood spot (finger-prick) test can reliably detect autoantibodies for diagnosing type 1 diabetes and celiac disease in children, making testing easier and less invasive. **You may be eligible if...** - Your child is between 2 and 13 years old - Your child either has a confirmed diagnosis of type 1 diabetes or celiac disease (positive group), or does not have these conditions and has no relevant autoantibodies (control group) - You have given informed consent on your child's behalf **You may NOT be eligible if...** - There are no exclusion criteria listed for this study — it is broadly open to eligible children in the age range Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTTest 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_TESTTest 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)