FDA Outlines Plan for Artificial Pancreas Approval

Dec. 1, 2011— -- The U.S. Food and Drug Administration today issued guidance for scientists and device manufacturers seeking approval for the artificial pancreas – a portable device to help people with type 1 diabetes control their blood sugar levels.

The draft guidance offers design and testing recommendations aimed at easing the approval process while still meeting statutory requirements for safety and effectiveness. It comes less than a month after lawmakers, health professionals, advocacy organizations and patients lobbied for expedited approval of the device.

"We understand how this device could change the lives of millions of Americans with diabetes, and we want our safety and effectiveness review to give patients the confidence that the device works," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement.

The guidance suggests ways to leverage existing safety and effectiveness data for components that make up the device, but still recommends three phases of clinical trials.

"Our initial review of the draft AP guidance indicates that the FDA has been responsive and listened to the recommendations of leading clinicians and researchers in the type 1 diabetes field," said Jeffrey Brewer, President and CEO of the Juvenile Diabetes Research Foundation. "It also appears that the draft guidance lays out a rapid timetable to move from inpatient trials to outpatient trials to prove the AP's safety and efficacy, and if that turns out to be the case it is good news."

Brewer's son has type 1 diabetes, meaning his body doesn't produce insulin. Type 1 diabetics either have to self-administer insulin or use pumps that release insulin throughout the day.

According to the JDRF, as many as three million Americans may have type 1 diabetes. Research published in April found that using the artificial pancreas was better at controlling blood sugar than an insulin pump. Low blood sugar during the night is often a problem for type 1 diabetics.

"[The system] has the potential to improve safety and efficacy of insulin delivery and may in future allow more flexible lifestyles in conjunction with improved glycemic control for people with type 1 diabetes," wrote the study authors, led by Roman Hovorka of the University of Cambridge.

One of the sticking points that could potentially delay the device's approval is the fact that continuous glucose monitors are not approved to provide insulin dosages, only to alert a person that blood sugar is high or low.

"Today's insulin systems are basing all dosing decisions on that monitor, so we need to make sure we test them appropriately," said Charles Zimliki, chair of the FDA's Artificial Pancreas Critical Path Initiative said in November.

Zimliki, a type 1 diabetic himself, said he wants the device to be approved as quickly as possibly.

"An artificial pancreas system could allow people with diabetes, especially children, to live active lives without the constant need to constantly monitor their glucose levels," he said in a statement today. "While not a cure, an artificial pancreas could reduce dangerous high and low blood sugars, providing a better quality of life for those with diabetes and lowering the risk for future diabetes-related complications."