16 September 2026 editorial review · Trial
Omnipod 5 preschool cohort (ages 2-5.9): 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: M–S
Outcome: Primary13week and extensionabstracts agree with stated outcomes; no pivotal severe lows/DKA versus1each extension. Registry exclusion forDKA hasexceptions, clarified.
Registry: NCT04476472. Endpoint reviewed: Incidence Rate of Severe Hypoglycemia (Events Per Person Months) (Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)); Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months) (Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)); Glycated Hemoglobin (A1C) (Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (180 days, 270 days, 360 days, and 450 days) compared to baseline); Time in Range 70-180 mg/dL (Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days)). Eligibility reviewed: Age 2 Years to 5 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Additional source access: Pivotal primary abstract; Extension primary abstract.