Control-IQ: FDA Approves Artificial Pancreas System

The U.S. Food and Drug Administration (FDA) has authorized a brand new synthetic pancreas system — designed to robotically monitor and regulate blood glucose ranges in folks with sort 1 diabetes — primarily based partially on the outcomes of a latest examine exhibiting that it helped enhance customers’ blood glucose management.

The newly authorized system, often 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 launch, it consists of an insulin pump that’s programmed with an algorithm to ship insulin primarily based on enter from a steady glucose monitoring (CGM) sensor, which can be worn by the person.

“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 heart, within the press launch.

The FDA’s approval follows the latest publication of a examine in The New England Journal of Medicine, exhibiting that the brand new system was more practical at controlling blood glucose in folks with sort 1 than different current applied sciences. In a trial that befell at a number of places, 168 contributors had been randomly assigned to make use of both the Control-IQ or separate insulin pumps and CGM techniques, with out computerized changes to insulin supply. Members of the Control-IQ group noticed a major enhance in how a lot time they spent inside their goal blood glucose vary, together with a decrease threat for each excessive 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 examine, within the press launch. “We are thankful to everyone that supported the development of the artificial pancreas,” which incorporates the National Institutes of Health (NIH), JDRF’s Artificial Pancreas Project, and different foundations.

The gadget is anticipated to begin reaching sufferers this month.

Want to study extra about sort 1 diabetes? Read “Type 1 Diabetes Questions and Answers,” “Six Type 1 Diabetes Symptoms You Need to Know” and see our sort 1 diabetes movies.

Quinn Phillips

A contract well being author and editor primarily based in Wisconsin, Phillips has a level in authorities from Harvard University. He writes on a wide range of subjects, however is very within the intersection of well being and public coverage.