16 September 2026 editorial review · Trial
CREATE: open-source automated insulin delivery vs sensor-augmented pump: 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: Corrected device phase and New Zealand location; kept DANA-i, which the NEJM primary report explicitly confirms as preproduction; removed unsupported direct relationships to unrelated systems and overstated universal safety/equal subgroup effects.
Registry: ACTRN12620000034932. Accessible primary literature: Extended Use of an Open-Source Automated Insulin Delivery System in Children and Adults with Type 1 Diabetes: The 24-Week Continuation Phase Following the CREATE Randomized Controlled Trial.; Open-Source Automated Insulin Delivery in Type 1 Diabetes.; CREATE (Community deRivEd AutomaTEd insulin delivery) trial. Randomised parallel arm open label clinical trial comparing automated insulin delivery using a mobile controller (AnyDANA-loop) with an open-source algorithm with sensor augmented pump therapy 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.