Diabetes Breakthrough: Artificial Pancreas Guidelines Detailed by FDA

Yesterday, the Food and Drug Administration (FDA) released guidelines outlining development and testing procedures for a new “artificial pancreas” device that could improve the lives of many Americans living with Type 1 Diabetes.

The device won’t actually replace a patients’ pancreas, but it will use a sensor under the skin to employ a constant glucose monitor as well as an insulin pump to override pancreatic function in individuals using the artificial pancreas. WebMD (somewhat worryingly) describes the FDA’s new guidelines as “designed to give researchers and industry a great deal of flexibility in order to get a safe and effective device to patients as quickly as possible,” and quoted the FDA’s Artificial Pancreas Working Groups and Critical Path Initiative’s head Charles “Chip” L. Zimliki, PhD, who was keen on getting a version of the device to market:

“Flexibility is one of the most important hallmarks of this guidance… Hopefully [approval for a version of the device] will happen sooner rather than later. As a person with type 1 diabetes, I hope it happens tomorrow.”

Zimliki continued:

“We have recommendations that we would encourage industry to follow in this process… but because this is an innovative device, we realize we don’t have all the answers and need to be open to new ideas. … We want these devices on the market as quickly as possible.”

He added that if an organization would “like to find a way to do it differently,” that the FDA’s Artificial Pancreas Working Groups and Critical Path Initiative would like to “encourage them to approach the agency.”