The company said that with the clearance, the FDA outlined standards for a new device category, the interoperable automated glycemic controller designation.
Tandem Diabetes Care has received FDA clearance for an insulin pump and delivery system that is the first of its kind to meet a classification of interoperable devices known as automated insulin dosing (AID).
The system includes the t:slim X2 insulin pump with Control-IQ technology, a hybrid-closed loop system that seeks to increase time in range (70 to 180 mg/dL) for blood glucose, a measure that is gaining ground as key health indicator and predictor of complications. The system integrates Dexcom G6 continuous glucose monitoring (CGM), which does not require fingerstick tests for calibration or for dosing decisions.
According to statement from Tandem, the technology represents “the first automated insulin dosing software in a new interoperable automated glycemic controller category that automatically adjusts insulin deliver for a person with diabetes by connecting to an alternate controller-enabled insulin pump and integrated continuous glucose monitor.”
Tandem will allow in warranty X2 pump users in the United States to add the new feature for free through a remote software update, which will be available by late January 2020. New pumps with the software will ship around that time, the statement said.
The interoperable automated glycemic controller designation creates a new device class, and the FDA has outlined requirements for future submissions in this category, the Tandem statement said. Standards include reliability, cybersecurity, interoperability, and clinical relevance data needed to show performance.
“Not only do new closed-loop systems need to be effective at improving glycemic control, they must also be easy to understand and use so patients can experience the full benefits of the technology,” Boris Kovatchev, PhD, director of the Center for Diabetes Technology at the University of Virginia, said in a statement.
“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 chief executive officer of Tandem Diabetes Care.
Tandem highlights several features of the software, including the ability to predict high and low blood glucose levels, to automatically correct boluses, and to accommodate sleep and exercise. Features of the hardware include the small size, the color touchscreen, and the ability to use the device without the CGM if desired.
A study in the New England Journal of Medicine showed that users rated the Control-IQ technology 4.7 out of 5 for ease of use and 4.8 out of 5 for a desire to keep using the system.