The U.S. Food and Drug Administration issued new guidelines on Thursday for the development of a potentially revolutionary device to treat type 1 diabetes that will give manufacturers ‘maximum flexibility’ in getting it to U.S. patients.

The guidelines reflect months of behind-the-scenes negotiations with patient advocates, medical device makers and researchers working to develop an artificial pancreas - a complex system of pumps and sensors aimed at automating the care and treatment of type 1 diabetes.

It is not yet clear if they will appease concerns that the FDA would set the bar too high, making regulations so cumbersome that it would delay access of these potentially revolutionary devices to diabetics in the United States.

“This guidance was developed in a way to account for innovation,” Charles “Chip” Zimliki, who heads an FDA initiative to speed up availability of an artificial pancreas, told Reuters in a telephone interview.

Zimliki said the new draft guidance gives researchers and medical device makers clear guidelines for approving clinical trials that can prove these devices are safe in real-world outpatient settings.

“I think we’re doing a really good job at getting these clinical studies going and we’re showing them a path that I think can get them to a safe and effective product in the U.S.,” he said.

Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement the new guidance will “provide maximum flexibility to manufacturers seeking to bring this device to U.S. patients.”

“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,” Shuren said.

Zimliki says the guidelines take into account concerns raised over guidelines for a very early version of an artificial pancreas device, known as a low glucose suspend device.

Those devices involve a safety feature built into an insulin pump that shuts off the pump when a diabetic’s blood sugar falls to dangerously low levels.

OUTSIDE OF BODY

The new guidelines are focused on more complex artificial pancreas devices that would automate many of the tasks a diabetic must do to manage their disease.

These systems are made up of medical devices worn outside of the body to take over for insulin-making cells in the pancreas, which become destroyed in people with type 1 diabetes.

The systems combine two medical devices, an insulin pump and a continuous glucose monitor or CGM that receives information on glucose levels from a sensor placed under the patient’s skin.

The pump and CGM work together, monitoring the body’s glucose levels and automatically pumping appropriate doses of insulin as determined by a computer algorithm.

These systems are meant to manage dangerous spikes and valleys in blood sugar that occur as diabetics try to manage the disease by checking their blood sugar and injecting themselves with insulin.

The FDA guidance document recommends a three-phase clinical trial progression leading to outpatient clinical trials.

And it suggests ways researchers can use existing safety and effectiveness data for various components that make up the system, including data gathered from clinical studies conducted outside of the U.S.

When final, the guidance will help manufacturers and investigators assemble submissions for clinical trials as well as product approval submissions.

The devices are aimed at treating the 3 million Americans with type 1 diabetes, an autoimmune disease in which the immune system destroys cells in the pancreas that make insulin.

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

People with type 1 diabetes currently must monitor their blood sugar and take insulin several times a day to regulate it and prevent diabetic complications, which include heart and kidney disease.

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By Julie Steenhuysen

CHICAGO