Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced Health Canada approval of the t:slim X2™ insulin pump with Control-IQ™ technology. Control-IQ technology is an advanced hybrid closed-loop feature designed to help increase time in range (3.9-10 mmol/L)1 and 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 fingersticks for calibration or diabetes treatment decisions.
All in-warranty t:slim X2 pump users in Canada will have the option to add Control-IQ technology to their existing pump beginning in March 2021 via remote software update. The update will be free of charge through December 31, 2021.5 Tandem expects to begin shipping t:slim X2 insulin pumps with Control-IQ technology in Canada in the first quarter of next year. The company will continue offering the t:slim X2 insulin pump with Basal-IQ™ predictive low glucose suspend technology for users seeking a system designed specifically to help prevent lows.
“The t:slim X2 insulin pump with Control-IQ technology is the most advanced automated insulin dosing system available in the world and is a testament to our commitment to improving the lives of people with diabetes,” said John Sheridan, president and CEO of Tandem Diabetes Care. “We are thrilled to be able to bring the benefits of this advanced hybrid closed-loop system to the Canadian diabetes community.”
Control-IQ technology uses Dexcom G6 CGM values to predict glucose levels 30 minutes ahead and adjust insulin delivery accordingly; including delivery of automatic correction boluses up to once per hour. If sensor glucose values are predicted to drop below 6.25 mmol/L, basal insulin delivery is reduced, and when predicted to be below 3.9 mmol/L, basal insulin delivery is stopped. If glucose values are predicted to be above 8.9 mmol/L, basal insulin delivery will be increased. If glucose values are predicted to be above 10 mmol/L, Control-IQ technology calculates an automatic correction bolus with a target of 6.1 mmol/L and delivers 60 percent of that value. It will do this up to once per hour as needed. Control-IQ technology also offers optional settings for sleep and exercise that will change the treatment values to better match the different physiologic needs during these activities.
Source: Company Press Release