PREDIDIA capillary-paper autoantibody test validation
What this study tests
PREDIDIA compares a combined three-autoantibody test on capillary blood collected on blotting paper with individual venous-blood assays in children presenting with stage 3 T1D. Use for earlier-stage screening remains a future aim.
Editorial review: . 16 September review-note archive (earlier notes may not cover later changes).
Registry checked: 2026-09-17. Registry’s own update: 2026-09-03.
Latest dated source in the citation list: 2026-09-03. This is the source’s date, not a new review of every claim.
Trial status, labels and access can change between reviews. Review coverage and open work · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Children older than 1 and younger than 18 with stage 3 T1D under the written inclusion criteria; the study-population field describes suspected stage 3 T1D. BMI must be below 30 kg/m², and additional exclusions apply. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- No results are posted in ClinicalTrials.gov as of 17 September 2026. This record describes the registered study plan, not demonstrated benefit or safety.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: European Union. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the 16 September review-note archive and current review coverage. Later changes and new records may not appear in the earlier notes. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Concordance between combined capillary-paper and individual venous anti-GAD65, anti-IA2 and anti-ZnT8 assays at day 1.
The full picture
The prospective observational study plans 106 children in France. Its primary question is assay agreement at clinical presentation with stage 3 T1D. It is not a population trial showing that this capillary-paper method predicts or prevents stage 3 diabetes in children without symptoms.1
The registered three-antibody panel includes anti-GAD65, anti-IA2 and anti-ZnT8; it does not include insulin autoantibodies. The description also proposes studying immunoreactive trypsin, but the structured outcome list contains only the primary antibody-concordance measure.1
The structured age fields say 1–18 years, whereas the written inclusion criteria specify older than 1 and younger than 18. This record follows the stricter written wording and leaves numeric age filters unset to avoid implying that both boundaries are inclusive.1
The registry lists study start 2025-11-05 (actual), primary completion 2027-11-05 (estimated) and study completion 2027-12-05 (estimated). These dates retain the registry’s actual or estimated labels; an estimated date is not confirmation that an event occurred.1
References
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ClinicalTrials.gov. NCT06984185. Last update posted 2026-09-03; checked 17 September 2026. https://clinicaltrials.gov/study/NCT06984185 ↩ ↩2 ↩3 ↩4
Sources
- [1]Early Detection of Type 1 Diabetes (NCT06984185) · Trial registry · 2026-09-03 — Current registered protocol, eligibility, endpoints and status checked 17 September 2026; the citation date records the registry update, not a results publication.