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.
Singleton pregnancy is confirmed by ultrasound.
Pregnant woman between pregnancy confirmation to 96/7 weeks gestation.
Clinical diagnosis of T1D for 1 year or longer.
Using insulin pump (AID/SAP) or multiple daily insulin injections at screening visit.
Individuals with T2D, gestational diabetes, or other types of diabetes (e.g., CFRD, MODY, etc.).
Use of basal insulin alone.
Use of short-acting insulin alone, unless use is through an insulin pump.
Severe allergy to medical grade adhesives within the last 3 months that would inhibit participant ability to wear the study devices.
Single group
Automated Insulin Delivery (AID)
DeviceThe 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.
Time in Range 60-140 mg/dL per night
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Mayo Clinic
Lead sponsor
Icahn School of Medicine at Mount Sinai
Collaborator
University of Colorado, Denver
Collaborator
Stanford University
Collaborator
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