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.
What Is Type 1 Diabetes?
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."
While the guidelines released today include recommendations on how to proceed during testing, the FDA says it is flexible in terms of specific study goals, the number of patients involved in studies, and the length of the studies. They also encourage researchers and manufacturers to discuss with them alternative means of testing devices.
"If a company would like to find a way to do it differently, we encourage them to approach the agency," Zimliki says.
He says the guidelines are "pretty novel -- one of the few written before a device has gone through the regulatory process."
The flexibility of the guidelines, Zimliki says, takes into account the fact that the devices are constantly being "changed, updated, modified" as they are tested. "We have recommendations that we would encourage industry to follow in this process," said Zimliki, "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."