The US Food and Drug Administration (FDA) today announced market authorization for an interoperable automated glycemic controller device that automatically adjusts insulin delivery to a person with diabetes
The Tandem Diabetes Care Control-IQ Technology connects to an alternate controller-enabled insulin pump and integrated continuous glucose monitor. The marketing authorization will allow integrated continuous glucose monitors and alternate controller-enabled insulin pumps to be used with an interoperable automated glycemic controller as a complete automated insulin dosing system.
The controller can automatically increase, decrease, and suspend delivery of basal insulin to the patient based on insulin delivery history, integrated continuous glucose monitor readings, and predicted glucose values. The Control-IQ Technology controller also automatically delivers the specific amount of insulin when the glucose value is predicted to go over a predetermined amount.
The federal regulator reviewed data of 168 patients with type 1 diabetes from a clinical trial of the Control-IQ Technology controller. Patients used either the Control-IQ Technology controller installed on a Tandem t:slim X2 insulin pump or a continuous glucose monitor and insulin pump without the Control-IQ Technology controller. The findings showed the controller determined safe, effective insulin delivery.
The authorization for the first controller of its type could allow equivalent controller technologies developed for diabetes in the future to go through the review process and help promote timely access to a technology that could improve care and quality life, Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
Although the system was deemed safe and effective by the FDA, the agency noted that risks associated with the interoperable device may still occur, which could lead to low or high blood glucose.
The FDA is also working to create special controls to outline regulatory requirements that provide assurance of the safety and effectiveness of this type of device. Special controls for this device include requirements related to reliability, device interoperability, cybersecurity, and clinical relevance. The agency created a new regulatory classification for devices like the Control-IQ Technology controller, so any similar devices with the same intended use can go through FDA’s 510(k) premarket process.
Aaron Kowalski, Ph.D., president and CEO of JDRF, wrote in a statement to MD Magazine®
that the approval is a huge win for the type 1 diabetes community and a big step forward in improving the lives of patients with the condition.
“Until we find cures, we are continuing to support the development of new technologies and treatments to improve blood sugar management so people with (type 1 diabetes) can live healthier and more manageable lives,” Kowalski said.