Tandem Diabetes Care (NSDQ:TNDM) announced today that it began the U.S. commercial launch of its t:slim X2 insulin pump with Control-IQ advanced hybrid closed-loop technology.
In December, the San Diego-based company announced that the FDA cleared the t:slim X2 insulin pump and Control-IQ technology for controlling Type 1 diabetes, touting it as the first and only system cleared to deliver automatic correction boluses in addition to adjusting insulin.
The t:slim system, which also includes the recently approved Dexcom G6 CGM, is designed to help increase time in range (70-180 mg/dL), requiring no fingersticks for calibration or diabetes treatment decisions. Tandem said users have the option to add the new feature free of charge and the pumps, which are pre-loaded with Control-IQ technology, are now shipping to new customers.
Control-IQ is the also touted as the first controller that can be used with other diabetes devices that are designed to be integrated into a customizable for an automated insulin delivery system. The system uses CGM values, in conjunction with other variables such as insulin on board, to predict glucose levels 30 minutes ahead and adjust insulin delivery accordingly. Control-IQ technology also offers optional settings for sleep and exercise that will change treatment values to 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,” Tandem Diabetes Care president & CEO John Sheridan said in a news release.
“We began processing orders earlier this month and are excited about the opportunity this launch presents for 2020,” Sheridan said. “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.”