New insulin pump with control technology launched in U.S.

Jan. 20, 2020

Tandem Diabetes Care, Inc. announced its commercial launch of the t:slim X2 insulin pump with Control-IQ technology, an advanced hybrid-closed loop feature designed to help increase time in range (70-180 mg/dL). It is the first and only system cleared to deliver automatic correction boluses in addition to adjusting insulin to help prevent high and low blood sugar. The system integrates with Dexcom G6 continuous glucose monitoring (CGM), which requires no finger-sticks for calibration or diabetes treatment decisions.

The new pump uses CGM values, in conjunction with other variables such as insulin on board, to predict sensor glucose levels 30 minutes ahead and adjust insulin delivery accordingly. If glucose values are predicted to drop below 112.5 mg/dL, basal insulin delivery is reduced, and when predicted to be below 70 mg/dL, basal insulin delivery is stopped. If glucose values are predicted to be above 160 mg/dL in the next 30 minutes, basal insulin will be increased. If glucose values are predicted to be above 180 mg/dL, Control-IQ technology calculates a correction bolus with a target of 110 mg/dL, and delivers 60 percent of that value up to once an hour as needed. Control-IQ technology also offers optional settings for sleep and exercise that will change treatment values to better match the different physiologic needs during these activities.

“Control-IQ technology has been described by study participants and investigators as ‘life-changing,’ ‘easy to use,’ and ‘a new standard of care in insulin therapy management,’ which is incredible feedback as we commence this commercial launch and begin bringing its benefits to more people with diabetes,” said John Sheridan, President and Chief Executive Officer. “We began processing orders earlier this month and are excited about the opportunity this launch presents for 2020. As these new customers move through the insurance verification process it will provide us with valuable trend information that will be used in setting our financial guidance for the year.”

The Company will soon begin sending emails with update instructions to all in-warranty t:slim X2 users in the U.S. who have the option to add the new feature free of charge via remote software update. The t:slim X2 pumps pre-loaded with Control-IQ technology are now shipping to new customers.

The Control-IQ technology update will require a new prescription and completion of online training, all of which will be coordinated through a simple-to-use online portal. Internet and computer access are required for pump updates. Control-IQ technology is only compatible with the Dexcom G6 CGM System. The t:slim X2 insulin pumps updated to Control-IQ technology cannot revert to previous software versions following this software update.

Tandem Diabetes Care has the announcement.