16 September 2026 editorial review · Trial
Omnipod 5 (Horizon) pivotal single-arm AID trial: 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: Distinguished241 publicationparticipants from240registry, added infusion-site causeofDKA and extension7severelows/1DKA; checkedprimaryabstracts.
Registry: NCT04196140. Endpoint reviewed: Incidence Rate of Severe Hypoglycemia (Events Per Person Months) (Phase 2 hybrid closed-loop (94 days)); Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months) (Phase 2 hybrid closed-loop (94 days)); Glycated Hemoglobin (A1C) (6 weeks continuous Phase 2 participation compared to baseline); Time in Range 70-180 mg/dL (Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days)). Eligibility reviewed: Age 6 Years to 70 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Additional source access: Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes.; Two Years with a Tubeless Automated Insulin Delivery System: A Single-Arm Multicenter Trial in Children, Adolescents, and Adults with Type 1 Diabetes.; Psychosocial outcomes with the Omnipod® 5 Automated Insulin Delivery System in caregivers of very young children with type 1 diabetes.; Extension primary abstract.