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16 September 2026 editorial review · Trial

AiDAPT: Automated Insulin Delivery in Pregnancy with Type 1 Diabetes: 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.

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Baseline trial evidence review: A–H

Outcome: Removed false first randomized pregnancy-trial claim; used FDA primary clearance; distinguished adjusted contrast and postpartum wider target/n57; added acute events from updated NEJM paper.

Registry: NCT04938557. Registered endpoint checked: The time spent with glucose levels between 3.5-7.8 mmol/L based on CGM measures (Time In Range TIR 3.5-7.8mmol/L) (Between 16 weeks gestation and delivery - an average of 18 weeks). Eligibility check: Registry age 18 Years to 45 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: Automated insulin delivery during the first 6 months postpartum (AiDAPT): a prespecified extension study.; Automated Insulin Delivery in Women with Pregnancy Complicated by 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. Full-report addition: Updated NEJM main paper reports six severe hypoglycemia events in closed loop versus five with standard care, and one DKA event in each arm. The postpartum extension uses the broader 70–180 mg/dL target and 57 participants; it is not the pregnancy endpoint.

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