Auto-antibody Dosage From Blood Spots for Diagnosis of Type 1 Diabetes and Celiace Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Test on blood sample, Test on dried blood sample.
- Who it may be relevant to
- Registry conditions: Celiac Disease in Children, Diabetes Mellitus, Type I, Screening. Basic parameters: 2 years — 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test 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. - Diagnostic 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)
Primary outcome measures
- 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]
Secondary outcome measures (5)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Italy · 1 center
- Meyer Children's Hospital IRCCS — Florence
Identifiers
NCT: NCT06849622 · CELDI