Tandem Diabetes Care, a San Diego, CA-based insulin delivery and diabetes technology company, announced U.S. Food and Drug Administration (FDA) clearance of the company’s t:slim X2™ insulin pump with Control-IQ™ technology, an interoperable automated glycemic controller device that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM).
“With this clearance, we will be launching the most advanced automated insulin dosing system commercially available in the world today,” said John Sheridan, president and CEO of Tandem Diabetes Care. “This is a testament to our commitment to improving the lives of people with diabetes by offering simple-to-use products that deliver superior performance.”
The FDA’s decision was based on a clinical trial of the Control-IQ Technology controller that included 168 participants with type 1 diabetes. The study demonstrated that the controller determines and commands safe and effective insulin delivery from a compatible ACE pump based on iCGM readings, with limited user intervention outside of mealtimes.
The t:slim X2 insulin pump with Control-IQ technology 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 the treatment values to better match the different physiologic needs during these activities, reports Business Wire.
With the interoperable automated glycemic controller designation, the FDA establishes a new device class which includes special controls outlining requirements for this and future submissions in this category, as well as describes the reliability, device interoperability, cybersecurity, and clinical relevance data required to demonstrate acceptable performance. The t:slim X2 insulin pump was also the first to receive an ACE infusion pump classification in February 2019, and the first insulin pump designated as compatible with iCGM devices in June 2018.
All in-warranty t:slim X2 pump users in the United States will have the option to add the new feature free of charge via remote software update.5 The update is expected to be available by the end of January 2020, and new pumps with Control-IQ technology will begin shipping to customers in the same timeframe.