SAN DIEGO – Tandem Diabetes Care has launched an at-home trial for its t:slim X2 insulin pump with a predictive low glucose suspend algorithm. “The start of this pivotal trial is another important step forward in our automated insulin delivery programs, and comes on the heels of very encouraging feasibility study data,” said Kim Blickenstaff, president and CEO of Tandem Diabetes Care, in a statement. The insulin pump system, which uses an integrated Dexcom G5 mobile continuous glucose monitor, is designed to suspend insulin delivery when low blood glucose is predicted and subsequently resume insulin delivery when glucose levels begin to rise. The study is a multi-center, randomized crossover study comparing two, three-week periods of at-home insulin pump use, one period using the t:slim X2 Pump with PLGS, and another period using a standard CGM-integrated t:slim X2 Pump without automated insulin suspension. The clinical trial will include 90 participants with Type 1 diabetes ages 6 and above at five research centers across the United States. Subject to FDA approval, the company plans to launch the pump next summer and will make the new feature available to existing t:slim X2 customers.
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