Tandem Diabetes reports successful completion of t:slim X2 Insulin Pump study
Tandem Diabetes Care reported the successful completion of the first pilot study using a hybrid closed loop system featuring its t:slim X2 Insulin Pump with embedded algorithms from TypeZero Technologies and integration with Dexcom G6 Continuous Glucose Monitoring. This pilot study was the first of three in the National Institute of Health-funded International Diabetes Closed Loop Trial using the t:slim X2 Pump running the algorithm directly on the pump. The second study is now moving forward with enrollment at seven clinical sites and is anticipated to begin in 1Q18. The IDCL Trial is expected to conclude with a pivotal study in 2018, and Tandem plans to use this data in a PMA submission to the U.S. Food and Drug Administration. The hybrid closed loop system predicts high and low blood sugar levels and adjusts insulin delivery accordingly throughout the day, while still allowing the user to manually bolus for meals. In addition to basal insulin adjustments, the system also automates correction boluses. The hybrid closed loop software developed by TypeZero includes a series of algorithms developed from initial research conducted at the University of Virginia. To date, this technology has been used in more than 30 clinical studies involving more than 450 participants, with data referenced in a number of journal articles.The IDCL Trial started in late 2016 and is expected to include up to 360 adults with type 1 diabetes across all of its studies. Earlier phases of the IDCL used a Tandem insulin pump and Dexcom G5 sensor as part of a blood glucose control system that combined these devices with a smartphone running TypeZero's inControl closed loop algorithms. The latest series of studies, now using the fully-integrated system, began with the supervised 36 to 48-hour pilot study in 5 subjects conducted at the University of Virginia. The next study, scheduled to take place in early 2018, will be a two-week, at-home study with enrollment at seven centers across the U.S. A pivotal trial is planned to take place at these same centers following successful completion and review of the two-week study.