16 September 2026 editorial review · Trial
Teplizumab managed-access programmes: retrospective real-world cohort: 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 →Primary-agent trial review — 16 September 2026
Assessment: Summary, current status, primary endpoint and key eligibility compared with the current registry. No additional discrepancy confirmed in that comparison. Historical outcome details beyond the primary sources explicitly discussed in the specialist ledgers were not all independently reverified.
Registry: NCT07457580; RECRUITING; updated 2026-08-26; enrollment 60 (ESTIMATED); results not posted.
Endpoint comparison: Participant demographics at teplizumab initiation (At Day 1 (first dose of teplizumab)); Participants' family history of T1D and autoimmune diseases (At Day 1 (first dose of teplizumab)); Presence of T1D susceptibility genes (At Day 1 (first dose of teplizumab)); Presence of T1D susceptibility genes (At Day 1 (first dose of teplizumab)); Participants' medical history (From 6 months prior to the first dose of teplizumab (teplizumab initiation) (or the earliest date of all data contributing to Stage 2 T1D diagnosis, whichever is earlier) up to medical records abstraction date, approximately 3-4 years).
Sources for this record: Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs) (registry).
Limits: Source access and review depth vary. Registry fields establish the registered study, not clinical benefit, product approval or current local access. Cited-source reachability alone was not treated as verification of its claims.