FDA authorizes marketing of first interoperable, automated insulin dosing controller
The device automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump and integrated continuous glucose monitor.
The FDA on Dec. 13, 2019, authorized marketing of the Tandem Diabetes Care Control-IQ Technology, the first interoperable, automated glycemic controller.
The device automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump and integrated continuous glucose monitor. Together, the three components create a complete automated insulin dosing system. Automated insulin dosing systems typically consist of a pump, continuous glucose monitor, and software to control the system of compatible devices.
In one study of 168 participants with type 1 diabetes, the controller determined and commanded safe and effective insulin delivery from a compatible alternate controller-enabled pump based on integrated continuous glucose monitor readings, with limited user intervention outside of mealtimes. Risks associated with the interoperable controller include delay of insulin delivery and incorrect insulin delivery as a result of loss of communication between connected devices or from exploitation of cybersecurity vulnerabilities.