INTERVIEW-US Regulators support device for diabetes

The Food and Drug U.S. (FDA, for its acronym in English) on Thursday released new guidelines for the development of a potentially revolutionary device to treat type 1 diabetes.

The guidelines are the result of months of negotiations between patient advocacy groups, medical device manufacturers and researchers working to develop an artificial pancreas, a complex system of pumps and sensors designed to automate the treatment of disease .

It remains unclear whether the rules will clear some doubts about whether the FDA would set standards too strict regulations that could hamper and delay access to computers.

"This guide was developed in order to account for innovation," Reuters said Charles "Chip" Zimliki, who heads an agency initiative to accelerate the availability of an artificial pancreas.

Zimliki said the new recommendations provide researchers and medical device manufacturers to adopt clearer guidelines clinical trials that could prove whether the computers are safe in the real world of patients.

"I think we're doing a good job in implementing these trials and we're showing a path that can lead to a safe and effective in the U.S.," he said.

Dr. Jeffrey Shuren, director of the Center for Devices and Health Radiological FDA said in a statement that the new guidelines "provide maximum flexibility for manufacturers looking to give this device to U.S. patients."

"We understand that the device could change the lives of millions of Americans with diabetes and we want our review of safety and effectiveness offer patients the confidence that the team works," said Shuren.

The devices are created to treat 3 million Americans with type 1 diabetes, an autoimmune disease in which the immune system destroys cells in the pancreas that produce insulin.

Formerly known as juvenile diabetes, type 1 diabetes is less common than type 2, the form of the disease linked to obesity and inactivity that affects 26 million people in the United States.

People with type 1 diabetes should monitor their blood sugar and take insulin several times a day to regulate and prevent complications such as diseases heart or kidney.