Tandem Diabetes Care (NSDQ:TNDM) touted data today from a pivotal study of its t:slim X2 insulin pump, which features a predictive low glucose suspend feature called Basal-IQ.
The study showed that the system reduced time spent in hypoglycemia by 31% compared to just sensor-augmented pump therapy, according to Tandem.
Tandem’s t:slim pump uses data from Dexcom’s G5 continuous glucose monitor to stop the flow of insulin when it predicts low blood glucose. The system then automatically begins delivering insulin when glucose levels start to rise again.
“Tandem’s t:slim X2 Insulin Pump with Basal-IQ proved easy to use, reduced time spent in hypoglycemia and improved time in range. These results are especially impressive given the study participants started out very well controlled, with a mean hemoglobin A1c of 7.3%. Participants also reported a high level of confidence using the system without a significant training burden to get started,” principal investigator Dr. Greg Forlenza said in prepared remarks.
“With increased availability and patient use of automated insulin delivery systems, we expect to see improvements in short-term complications such as hypoglycemia, and a decrease in patients’ daily burden of diabetes and long-term complications.”
“Reducing the risk of hypoglycemia has been the most requested feature of automated insulin delivery in our market research, due to the severity of the complications when left untreated. The data from this study supports our mission to improve the lives of people with diabetes through new innovations, such as the t:slim X2 Pump with Basal-IQ technology,” Kim Blickenstaff, Tandem’s president & CEO, added. “These results will support a PMA submission that we are on track to submit this quarter, and we continue to prepare for a launch in summer of 2018, pending FDA review and approval.”
