Early detection of type 1 diabetes using a finger‑prick blotting‑paper antibody test
Official title: 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)
Run by Hospices Civils de Lyon · NCT06984185 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 1 Year to 18 Years |
| Sex | All |
| Enrollment | 106 (estimated) |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Bron, Rhône) |
| Status | Recruiting |
| Started | November 5, 2025 |
| Main results expected | November 5, 2027 |
| Study ends | December 5, 2027 |
| Registry record updated | September 3, 2026 |
| Trial ID | NCT06984185 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.