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16 September 2026 editorial review · Trial

Twiist / Tidepool Loop in 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.

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Primary-agent trial review — 16 September 2026

Assessment: New 32-person device protocol, pregnant participants aged 18–45 in early gestation; no results. Registry primary nighttime range 60–140 differs standard pregnancy range 63–140; preserved exact study range.

Registry: NCT07808385; NOT_YET_RECRUITING; updated 2026-09-08; enrollment 32 (ESTIMATED); results not posted.

Endpoint comparison: Time in Range 60-140 mg/dL per night (30 weeks).

Sources for this record: Single Arm Intervention Trial of DEKA TWIIST TM Insulin Pump Utilizing Tidepool Loop Algorithm in Pregnant People With Pre-existing Type 1 Diabetes (NCT07808385) (registry).

Limits: Source access and review depth vary. Registry fields establish the registered study, not clinical benefit, product approval or current local access. Cited-source reachability alone was not treated as verification of its claims.

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