Twiist / Tidepool Loop in pregnancy
What this study tests
A newly registered single-arm study of the twiist pump and Tidepool Loop algorithm in pregnancy with pre-existing T1D. It plans 32 participants and is not yet recruiting.
Editorial review: . What was checked and what remains uncertain.
Registry checked: 2026-09-16. Registry’s own update: 2026-09-08.
Source dates appear in the references where available; this record has no dated citation metadata.
Trial status, labels and access can change between reviews.
Evidence at a glance
- Who can enter the study?
- Adults aged 18–45 with a singleton pregnancy, from pregnancy confirmation through 9 weeks and 6 days, and T1D for at least a year. Participants must meet detailed obstetric and device criteria and have an available care partner. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- No results posted. The registered primary measure is nighttime glucose time in 60–140 mg/dL (about 3.3–7.8 mmol/L) over 30 weeks. This range is reproduced from this protocol; it is not a replacement for a clinician’s pregnancy targets. The single-arm design has no randomized comparator.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: United States. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read this trial’s review notes for the checks completed and what remains unresolved. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Time in Range 60-140 mg/dL per night — 30 weeks
The full picture
What the study asks
A newly registered single-arm study of the twiist pump and Tidepool Loop algorithm in pregnancy with pre-existing T1D. It plans 32 participants and is not yet recruiting.
Who it involves
Adults aged 18–45 with a singleton pregnancy, from pregnancy confirmation through 9 weeks and 6 days, and T1D for at least a year. Participants must meet detailed obstetric and device criteria and have an available care partner. This is a summary; the full registry lists additional criteria.1
Design and timing
The registry lists 32 participants (estimated enrollment). Primary completion: 2027-05 (estimated). Study completion: 2028-12 (estimated). Estimated dates can change and do not mean results are available.1
Evidence and limits
No results posted. The registered primary measure is nighttime glucose time in 60–140 mg/dL (about 3.3–7.8 mmol/L) over 30 weeks. This range is reproduced from this protocol; it is not a replacement for a clinician’s pregnancy targets. The single-arm design has no randomized comparator.
References
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ClinicalTrials.gov. NCT07808385. Record checked 16 September 2026; last update posted 2026-09-08. https://clinicaltrials.gov/study/NCT07808385 ↩ ↩2
Sources
- [1]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 — Protocol and current registry status checked 16 September 2026.