Mayo Clinic
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.
Inclusion Criteria: * 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. * Willing to use U100 aspart (Novolog) or lispro (Humalog) insulin during the study. * Willing to announce all carbohydrate intake unless for the treatment or prevention of hypoglycemia. * No significant maternal and/or fetal complications at the time of enrollment visit. * Willing to abide by study protocol. * Willi…
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.