Tandem highlights insulin delivery algorithm, wins IDE approval
Tandem Diabetes Care (NSDQ:TNDM) touted data from a feasibility study of its predictive low glucose suspend algorithm, which is designed to suspend insulin delivery when the algorithm predicts low blood sugar. The company also said that it won approval for its investigational device exemption application to begin a pivotal trial of its algorithm with the t:slim X2 insulin pump.
The company’s 10-patient trial evaluated the system in patients with Type I diabetes ages 18 to 30. The researchers induced low glucose via increased basal insulin overnight.
The team reported that the algorithm performed as expected, successfully stopping insulin delivery when continuous glucose monitoring values were predicted to be low and then resuming insulin when the values began to rise. The researchers also said they did not observe any hypoglycemic events during the study.
““The Tandem predictive low glucose suspend algorithm was extremely effective in anticipating low blood sugar and modulating insulin delivery accordingly,” Dr. Gregory Forlenza, from the Barbara Davis Center for Diabetes, said in prepared remarks. “The touchscreen on the Tandem pump was simple to read and interpret, and this algorithm requires minimal interaction to operate. Based on this study, we are enthusiastic about the potential for this product, and we look forward to seeing data from the upcoming pivotal trial.”
“The results from this feasibility study are very encouraging. The IDE for our pivotal trial, which will use the predictive low glucose suspend algorithm on a t:slim X2 Pump with Dexcom G5 Mobile CGM integration, was approved by the FDA in May, and we look forward to starting enrollment soon,” president & CEO Kim Blickenstaff added. “Our goal remains to submit our t:slim X2 Pump with predictive low glucose suspend to the FDA later this year, and we continue to plan for launch of this product in early 2018, subject to FDA approval.”