The U.S. Food and Drug Administration (FDA) has issued a rule book for scientists and device manufacturers who are working towards an artificial pancreas – a portable device to help people with type 1 diabetes control their blood sugar levels.
The guidelines outline recommendations for design and testing that could help ease the approval process while still meeting statutory requirements for safety and effectiveness. This comes in the wake of the movement from lawmakers, health professionals, advocacy organizations and patients who wish speedy approval processes for devices.
“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 “It also appears that the draft guidance lays out a rapid timetable to move from inpatient trials to outpatient trials to prove the AP's safety and efficacy, and if that turns out to be the case it is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.”
The devices are meant to help the 3 million Americans with type 1 diabetes, a disease in which the immune system destroys cells in the pancreas that make insulin. 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.
“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. “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.” “We're showing them a path that I think can get them to a safe and effective product in the U.S.,” he said.
Patient advocates feared the FDA would take an excessively cautious stance, pointing to requirements issued in June for a very early version of an artificial pancreas device that is already sold in 50 countries but not the United States.
“It was a guidance for a product that had already been approved around the world, had been used by thousands of people with significant positive impact, and the U.S. was significantly behind on that front,” Aaron Kowalski, lead researcher at the Juvenile Diabetes Research Foundation, told a media briefing.