Exceptional Usability of Tandem t:slim X2 with Basal-IQ Predictive Low-Glucose Suspend (PLGS)—The PROLOG Study

Background: Our research study group recently evaluated a PLGS system embedded on the Tandem t:slim X2 with Basal-IQ insulin pump. The system was designed to work "in the background" without alarms when suspending and restarting insulin delivery. System usability and effectiveness in decreasing hypoglycemia are both critical to the success of a PLGS device. Methods: The PROLOG study was a randomized crossover trial conducted at 4 U.S. sites. Participants with type 1 diabetes (age ≥6 years, n=102) previously treated with MDI or CSII (with and without CGM) were randomized to the order of treatment: PLGS during one 3-week period and sensor-augmented pump (SAP) during the alternate 3-week period. We recently reported the primary outcome of the PROLOG study-a reduction of mean sensor time