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

概要

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.