Early detection of type 1 diabetes using a finger‑prick blotting‑paper antibody test
Contribution of a Combined T1D Autoantibody Test and Immunoreactive Trypsin Assay on Blotting Paper in the Detection of Type 1 Diabetes (Stage 3) in the Pediatric Population With a View to Its Subsequent Use in Early Detection (Stages 1 and 2)
We will test whether a combined antibody test on finger‑prick blotting paper can reliably detect the three common type 1 diabetes autoantibodies in children newly diagnosed with type 1 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 106 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Bron, Rhône) |
| Trial ID | NCT06984185 on ClinicalTrials.gov |
What this trial studies
This observational study compares a combined capillary blotting‑paper assay to standard individual venous blood assays for anti‑GAD65, anti‑IA‑2, and anti‑ZnT8 antibodies at the time of clinical (stage 3) type 1 diabetes diagnosis. Children aged over 1 and under 18 with BMI <30 and a new stage 3 T1D diagnosis will provide both a finger‑prick blotting‑paper sample and venous blood for antibody measurement. The primary analysis will measure concordance between the combined capillary test and the three individual venous assays. The goal is to validate the blotting‑paper approach as a simpler option that could be used for wider presymptomatic pediatric screening.
Who should consider this trial
Good fit: Children aged 1 to under 18 with newly diagnosed (stage 3) type 1 diabetes, BMI under 30, and no parental opposition are the ideal candidates for this validation study.
Not a fit: Patients with type 2 or known monogenic diabetes, cystic fibrosis, significant liver or kidney disease, pancreatitis, other progressive diseases, or those outside the age/BMI criteria are unlikely to benefit from this specific validation.
Why it matters
Potential benefit: If successful, the combined blotting‑paper test could make presymptomatic antibody screening easier to do at home or in routine clinics, enabling broader early detection of type 1 diabetes.
How similar studies have performed: Prior validation work on capillary blood spot assays has shown promising concordance for individual T1D autoantibodies, but combined three‑antibody capillary testing in pediatric stage 3 cases requires this specific validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Children aged over 1 year and under 18 years * BMI \<30.0 kg/m2 * With a diagnosis of stage 3 type 1 diabetes (clinical and laboratory criteria, metabolic acidosis, ketone levels) * Child's consent and no parental opposition Exclusion criteria * Patients with T2D or monogenic diabetes with a known familial history * Patients with cystic fibrosis * History of liver or kidney disease, or pancreatitis * Any progressive disease (other than T2D)
Where this trial is running
Bron, Rhône
- Femme Mère Enfant Hospital, Hospices Civils de Lyon — Bron, Rhône, France (Recruiting)
Study contacts
- Study coordinator: Kevin PERGE, Dr
- Email: kevin.perge@chu-lyon.fr
- Phone: 0472129525
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.