16 September 2026 editorial review · Trial
DIAGNODE-1: First intralymphatic GAD-alum dosing study: 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.
Read the trial evidence page →Baseline trial evidence review: A–H
Outcome: Qualified safety inference from12-person uncontrolled pilot; registry primary safety and published immune-response signal checked, not proof of efficacy.
Registry: NCT02352974. Registered endpoint checked: Number of Subjects With Injection Site Reactions Month 1 (Month 1); Number of Subjects With Injection Site Reactions Month 2 (Month 2); Number of Subjects With Injection Site Reactions Month 3 (Month 3); Number of Subjects With Injection Site Reactions Month 32 (Month 32, extension period). Eligibility check: Registry age 12 Years to 30 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Accessible primary literature: Intralymphatic Glutamic Acid Decarboxylase-Alum Administration Induced Th2-Like-Specific Immunomodulation in Responder Patients: A Pilot Clinical Trial in Type 1 Diabetes.. Limits: Primary abstract findings were available; supplementary tables and full adverse-event adjudication were not comprehensively re-reviewed. Registry eligibility is not a claim of current site availability.