Dec. 1, 2011 -- The FDA today released new guidelines for the development and testing of artificial pancreas devices for the treatment of type 1 diabetes.
The guidelines are 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.
"Flexibility is one of the most important hallmarks of this guidance," Charles "Chip" L. Zimliki, PhD, leader of the FDA's Artificial Pancreas Working Groups and Critical Path Initiative, told reporters at a news conference today.
A primary goal, Zimliki says, is to move clinical trials to an outpatient setting to see how they function in a "real world setting."
While Zimliki referred to the device as an artificial pancreas, it does not actually replace that organ, which is responsible for the production of insulin. Instead, a two-part device -- combining an insulin pump and a continuous glucose monitor -- would take over that function, constantly monitoring blood sugar levels via a sensor placed under the skin.
The insulin pump and continuous glucose monitor would work together in controlling blood sugar (glucose) levels. If blood sugar levels were to become too high or low, the insulin pump would be programmed to make adjustments in insulin-dosing to bring blood sugar levels back to a normal level.
The devices, if approved, have the potential to vastly improve the lives of the approximately 3 million people in the U.S. who have type 1 diabetes. These patients must constantly monitor their blood sugar levels throughout the day and inject insulin when needed.
Type 1 diabetes, which often starts in childhood or early adulthood, is a chronic autoimmune disease in which the immune system attacks the insulin-producing beta cells in the pancreas. Its causes are unknown and there is no known cure.
Zimliki says there are currently more than 20 studies of various devices underway. He says the data he has seen so far are encouraging.
"Hopefully it [approval for one or more device] will happen sooner rather than later," Zimliki says. "As a person with type 1 diabetes, I hope it happens tomorrow."