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16 September 2026 editorial review · Trial

Diamyd GAD-alum in people at risk for T1D: review notes

These notes document the scope actually reviewed, including source-access limits. They are not independent clinical certification or a guarantee that every claim was verified.

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Baseline trial evidence review: A–H

Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.

Registry: NCT05683990. Registered endpoint checked: Occurrence of AEs (including Injection site reactions) and SAEs (From screening to 12 months.); Number of Clinically Significant Abnormal Results from Physical examinations, including neurological and Vital Signs assessments (From screening to 12 months.); Number of Clinically Significant Abnormal Results From Laboratory measurements, including hematology, clinical chemistry, metabolic status parameters (fasting C-peptide, HbA1c, fasting glucose) and urine analysis (From screening to 12 months.). Eligibility check: Registry age 8 Years to 18 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.

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