Tandem Diabetes Care’s Control-IQ Technology last week won marketing approval from the U.S. Food and Drug Administration.
The interoperable, automated glycemic controller device automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump and integrated continuous glucose monitor. It is the first controller that can be used with other diabetes devices also designed to be integrated into a customizable diabetes management system for automated insulin delivery.
This FDA authorization paves the way for iCGMs and ACE pumps to be used with an interoperable automated glycemic controller as a complete automated insulin dosing system. AID systems typically consist of a pump, CGM and software to control the system of compatible devices.
The Control-IQ Technology can be used by patients with type 1 diabetes to automatically increase, decrease and suspend delivery of basal insulin to the patient based on insulin delivery history, iCGM readings and predicted glucose values. The controller can also automatically deliver a specific amount of insulin when the glucose value is predicted to exceed a predefined amount.
“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.”
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. 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. The Company will continue to offer the t:slim X2 pump with Basal-IQ® predictive low glucose suspend technology as an option for people who prefer a system designed specifically to help prevent lows.
Other software to automatically control insulin delivery has previously been approved by the FDA as part of a single, predefined diabetes management system. The Control-IQ Technology controller, which is designed to communicate with other compatible diabetes device components meant for an integrated, modular system, was reviewed through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.