FDA News

FDA approves t:slim X2 pump with predictive suspend algorithm

The FDA has approved the t:slim X2 Insulin Pump with Basal-IQ, a predictive low-glucose suspend feature that halts insulin delivery when a glucose drop into hypoglycemic range is anticipated, according to a press release from manufacturer Tandem Diabetes Care.

The predictive algorithm calculates glucose levels 30 minutes into the future. When low glucose level is expected, the device suspends insulin delivery until glucose level begins to rise again, according to the release.

The insulin pump is approved for use in people with diabetes aged 6 years through adulthood. It will be released with the Dexcom G6 continuous glucose monitoring system, which does not require fingerstick calibration.

“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,” said Kim Blickenstaff, president and CEO of Tandem Diabetes Care. “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 [integrated continuous glucose monitoring] 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.”

Tandam expects the t:slim X2 Insulin Pump with Basal-IQ to be available in August, according to the release, and users can choose when to use the automatic glucose suspend feature.

An update to the free t:simulator app will be available in July to allow users to familiarize themselves with the technology. Existing t:slim X2 Insulin Pumps still in warranty will be able to be updated online to the Basal-IQ technology without charge. The update will require a health care provider prescription and completion of a 45-minute online training session.

 

The FDA has approved the t:slim X2 Insulin Pump with Basal-IQ, a predictive low-glucose suspend feature that halts insulin delivery when a glucose drop into hypoglycemic range is anticipated, according to a press release from manufacturer Tandem Diabetes Care.

The predictive algorithm calculates glucose levels 30 minutes into the future. When low glucose level is expected, the device suspends insulin delivery until glucose level begins to rise again, according to the release.

The insulin pump is approved for use in people with diabetes aged 6 years through adulthood. It will be released with the Dexcom G6 continuous glucose monitoring system, which does not require fingerstick calibration.

“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,” said Kim Blickenstaff, president and CEO of Tandem Diabetes Care. “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 [integrated continuous glucose monitoring] 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.”

Tandam expects the t:slim X2 Insulin Pump with Basal-IQ to be available in August, according to the release, and users can choose when to use the automatic glucose suspend feature.

An update to the free t:simulator app will be available in July to allow users to familiarize themselves with the technology. Existing t:slim X2 Insulin Pumps still in warranty will be able to be updated online to the Basal-IQ technology without charge. The update will require a health care provider prescription and completion of a 45-minute online training session.