Single Arm Intervention Trial of DEKA TWIIST TM Insulin Pump Utilizing Tidepool Loop Algorithm in Pregnant People With Pre-existing Type 1 Diabetes

Part of paid clinical trials in Stanford, California.

Sponsor
Mayo Clinic
Study ID
NCT07808385
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Automated Insulin Delivery (AID) — DEVICE
    The AID control algorithm, that will be used during the study employs a model-based predictive control algorithm to forecast future glucose levels. This predictive model accounts for the impact of delivered insulin, user-entered carbohydrates, and incorporates two short-term adaptations: "glucose momentum" and "retrospective correction." These features work to optimize glucose management with precision. The impact of carbohydrates is calculated based on the user-defined insulin-to-carbohydrate ratio and insulin sensitivity factor (ISF), while the insulin effect is governed by the ISF itself. The system then dynamically adjusts insulin delivery, aiming to bring glucose levels in line with the midpoint of the user's personalized glucose target range. Loop fine-tunes insulin delivery by increasing or decreasing the basal insulin rate, as needed, each time a new CGM value is received.

Study Details

Suboptimal glycemic control during pregnancy contributes to adverse maternal and fetal health outcomes and previous automated insulin delivery (AID) studies have demonstrated improvement in glucose control across all ages and sexes irrespective of past treatment modality or diabetes duration with no increase in hypoglycemia. However, very few studies evaluating AID system use in pregnancy have been performed in the US and no AID systems are currently approved for use during pregnancy. The objective of this trial is to evaluate the safety and efficacy of THE TWIIST™ system that enables the selection of pregnancy-specific glucose targets. This phase 3 pivotal trial will assess the system's performance in pregnant people with pre-existing type 1 diabetes in the US, starting as early as pregnancy confirmation, continuing throughout the pregnancy including delivery and up to 6 weeks post-partum.

Key Dates

First listed
Sep 8, 2026
Start date
Sep 30, 2026
Status verified
Sep 2026
Primary completion
May 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AID and CGM

Primary Outcome Measure

Time in Range 60-140 mg/dL per night [ Time Frame: 30 weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305
Rayhan Lal, MD
[email protected]
8139758690
University of Colorado, Anschutz Medical CampusAuroraColorado80045
Sarit Polsky, MC
[email protected]
8139758690
Mayo ClinicRochesterMinnesota55905-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Carol Levy, MD
[email protected]
8139758690

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Type 1 diabetes
By specialty
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By research site
Stanford University· Stanford, CAUniversity of Colorado, Anschutz Medical Campus· Aurora, COMayo Clinic· Rochester, MNIcahn School of Medicine at Mount Sinai· New York, NY

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