An interventional study of Test on blood sample and Test on dried blood sample in Celiac Disease in Children, Diabetes Mellitus, Type I and Screening, sponsored by Meyer Children's Hospital IRCCS. Recruiting at 1 site in Italy. Open to participants aged 2 Years to 13 Years. Per ClinicalTrials.gov, last updated 2025-02-27.
Sponsored by Meyer Children's Hospital IRCCS · Not applicable, Interventional, and Diagnostic
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.
333 studies on the registry are indexed under Celiac Disease; 78 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 50 across 203 interventional studies indexed under Celiac Disease.
Browse Celiac Disease studies →Meyer Children's Hospital IRCCS is the lead sponsor of 78 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Diagnostic Test: Test on blood sample
Diagnostic Test: Test on dried 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.
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)
Comparability between spot and serum tests of the following parameters tissue transglutaminase Immunoglobuline A (tTg IgA) test, reference values <16 Units/ml
Time frame: Baseline
Comparability between spot and serum tests of the following parameters: anti-insulin antibodies (IAA) test, reference values <10 Units/ml
Time frame: Baseline
Comparability between spot and serum tests of the following parameters: protein tyrosine phosphatase antibodies (IA2) test, reference values <7.5 Units/ml
Time frame: Baseline
Comparability between spot and serum tests of the following parameter glutamic acid decarboxylase antibodies (GAD-65) test, reference values <5.5Units/ml
Time frame: Baseline
Comparability between spot and serum tests of the following parameter zinc transporter 8 (ZnT8) test, reference values <15Units/ml
Time frame: Baseline
Antibody titers (Units/ml) for coeliac disease autoantibodies and type 1 diabetes
Time frame: Baseline
Plan to share: No
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Meyer Children's Hospital IRCCS