16 September 2026 editorial review · Trial
Commercial or open-source closed-loop impact on pregnancy: 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: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT06654713. Registered endpoint checked: Large for gestational age (LGA) (At delivery); Core score on Type 1 Diabetes Distress Assessment Scale (T1-DDAS) (From enrollment to 8 weeks postpartum); Hypertensive disorders of pregnancy (HDP) (From enrollment to 8 weeks postpartum.); Time in pregnancy-specific range (psTIR) (From enrollment to 8 weeks postpartum.). Eligibility check: Registry age 18 Years to not specified; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.