The U.S. Food and Drug Administration (FDA) has approved a new artificial pancreas system — designed to automatically monitor and regulate blood glucose levels in people with type 1 diabetes — based in part on the results of a recent study showing that it helped improve users’ blood glucose control.
The newly approved system, known as Control-IQ and manufactured by Tandem Diabetes Care, was developed in partnership with the University of Virginia (UVA) Center for Diabetes Technology. As described in a UVA press release, it consists of an insulin pump that’s programmed with an algorithm to deliver insulin based on input from a continuous glucose monitoring (CGM) sensor, which is also worn by the user.
“This is a new-generation interoperable automated glucose control system, which allows seamless integration of a continuous glucose sensor, insulin pump and a smart control algorithm,” explains Boris Kovatchev, director of the UVA center, in the press release.
The FDA’s approval follows the recent publication of a study in The New England Journal of Medicine, showing that the new system was more effective at controlling blood glucose in people with type 1 than other existing technologies. In a trial that took place at several locations, 168 participants were randomly assigned to use either the Control-IQ or separate insulin pumps and CGM systems, without automatic adjustments to insulin delivery. Members of the Control-IQ group saw a significant increase in how much time they spent within their target blood glucose range, along with a lower risk for both high and low blood glucose.
“Artificial pancreas systems can help people with type 1 diabetes improve blood sugar control while also making it easier for them to manage their blood sugar levels,” says Sue Brown, MD, an endocrinologist at UVA and lead investigator of the study, in the press release. “We are thankful to everyone that supported the development of the artificial pancreas,” which includes the National Institutes of Health (NIH), JDRF’s Artificial Pancreas Project, and other foundations.
The device is expected to start reaching patients this month.