FDA clears interoperable automated glycemic controller
The Food and Drug Administration has given clearance to a medical device that automatically adjusts insulin delivery for diabetics by linking to an insulin pump and integrated continuous glucose monitor.
According to the FDA, Tandem Diabetes Care’s Control-IQ Technology is the first interoperable automated insulin-dosing controller designed to allow more choices for patients looking to customize their individual diabetes management device system.
While other software to automatically control insulin delivery has previously been approved by the FDA as part of a single, predefined diabetes management system, the regulatory agency contends that the Control-IQ Technology controller communicates with other compatible diabetes device components designed to be integrated into a modular system.
Specifically, the FDA authorization of the Control-IQ Technology controller enables integrated continuous glucose monitors (ICGM) and alternate controller-enabled insulin pumps (ACE) to be used with an interoperable automated glycemic controller as a complete automated insulin dosing system.
“Regulatory authorization of the Tandem Control-IQ algorithm for use as part of a hybrid closed-loop system is a huge win for the type 1 diabetes community and a critical step forward in making day-to-day life better for people living with the disease,” says Aaron Kowalski, president and CEO of JDRF, a not-for-profit organization that funds type 1 diabetes research and supported the development of the algorithm.
“People with different devices could use the algorithm and manage their glucose levels in a way that works best for them,” adds Kowalski.
The FDA’s approval to market the Control-IQ Technology is based on data from a clinical trial of the 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 meal times,” according to the agency.
Nonetheless, the FDA warns that despite the system being assessed for reliability, incorrect and inappropriate calculation and command—as well as delay of insulin delivery—can still occur.
“Other risks associated with use of the interoperable controller can include incorrect insulin delivery as a result of loss of communication between connected devices, or from exploitation of cybersecurity vulnerabilities,” the agency adds.
In addition to the FDA’s authorization of the Control-IQ Technology, the FDA has created criteria—called special controls—designating specific regulatory requirements that, when met along with general controls, provide a reasonable assurance of device safety and effectiveness for devices of this type.
“The marketing authorization of this first stand-alone interoperable automated glycemic controller also allows substantially equivalent controller technologies that are developed for diabetes in the future to go through the 510(k) review process, helping to promote timely patient access to innovative technologies that can improve their care and quality of life,” says Tim Stenzel, MD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.