Testing blood samples for early diagnosis of type 1 diabetes and celiac disease
Auto-antibody Dosage From Blood Spots for Diagnosis of Type 1 Diabetes and Celiace Disease
NA · Meyer Children's Hospital IRCCS · NCT06849622
This study is testing if a new way of checking blood samples can help find type 1 diabetes and celiac disease earlier in children.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 2 Years to 13 Years |
| Sex | All |
| Sponsor | Meyer Children's Hospital IRCCS (other) |
| Locations | 1 site (Florence, Italy) |
| Trial ID | NCT06849622 on ClinicalTrials.gov |
What this trial studies
This pilot study focuses on the early diagnosis of type 1 diabetes and celiac disease in children by screening for autoantibodies in blood samples. It aims to evaluate the concordance of results obtained from two different methods: dried blood spots on cards and traditional serum samples. The study will also assess the feasibility and acceptability of this screening approach among pediatricians and the local population in Tuscany. By identifying these conditions early, the study seeks to facilitate timely intervention and prevent severe complications.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2-13 years who either have a confirmed diagnosis of type 1 diabetes or celiac disease or are healthy controls without these conditions.
Not a fit: Patients outside the age range of 2-13 years or those with other unrelated health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and treatment of type 1 diabetes and celiac disease in children, potentially reducing the risk of severe health complications.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in early diagnosis of autoimmune conditions through blood screening methods.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Florence, Italy
- Meyer Children's Hospital IRCCS — Florence, Italy, Italy (RECRUITING)
Study contacts
- Study coordinator: Chiara Azzari
- Email: chiara.azzari@meyer.it
- Phone: +3905556621
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Celiac Disease in Children, Diabetes Mellitus, Type I, Screening