The FDA this week approved Tandem Diabetes Care‘s (NSDQ:TNDM) t:slim X2 insulin pump with a predictive low glucose suspend feature designed to cut the frequency and duration of hypoglycemia.
The San Diego, Calif.-based company said that upon launch, its new product will also feature Dexcom‘s (NSDQ:DXCM) G6 continuous glucose monitoring system. Tandem expects that the latest iteration of its insulin pump will be available in August.
The company’s Basal-IQ algorithm is designed to predict where a user’s glucose levels are heading 30 minutes in the future. When it predicts low glucose values, the device suspends insulin delivery and then automatically resumes once glucose levels rise.
In a pivotal trial, patients who used the t:slim pump with Basal-IQ tech had a 31% reduction in time spent below range with no rebound hyperglycemia compared to a CGM-enabled insulin pump without the algorithm, according to Tandem.
“The t:slim X2 Pump with Basal-IQ technology was designed to predict and help prevent time spent low using best-in-class CGM technology,” president & CEO Kim Blickenstaff said in prepared remarks. “As the first company to launch a touchscreen insulin pump capable of remote feature updates, and now the first to have a pump approved with iCGM compatibility, we are delivering new innovation to our customers at a pace that is unprecedented in our industry, furthering our mission to help improve the lives of people with diabetes.”
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