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FDA Moves to Speed Development of Artificial Pancreas Systems
Date:12/1/2011

By Steven Reinberg
HealthDay Reporter

THURSDAY, Dec. 1 (HealthDay News) -- The U.S. Food and Drug Administration on Thursday issued new guidelines aimed at helping speed up the development of artificial pancreas systems.

If they become a reality, such technologies could make a huge difference for people with type 1 diabetes, who need insulin injections to control their blood sugar and survive.

Artificial pancreas systems combine current technologies for continuous blood sugar monitoring and pumps to deliver insulin as needed. These systems are designed to keep patients' insulin levels within normal ranges, by reacting to changes in blood sugar.

So far, however, equipment problems, computer glitches and problems with the insulin used have hampered development of these systems, the FDA said in a news release.

"We really are trying to get these devices to the market as quickly as possible," Charles Zimliki, leader of the FDA's Artificial Pancreas Working Groups and Critical Path Initiative, said during a news conference Thursday.

That's why the agency has taken the unusual step of developing a guidance for approval, something which is usually done after a device had been developed and tested, he said.

Zimliki said he has no idea when an approved device might be available. To date, the FDA has approved more than 20 clinical studies for artificial pancreas systems.

The FDA's new guidelines make designing, testing and safety and effectiveness requirements more flexible. For example, they propose more flexibility in the choice of clinical trial outcomes, number of patients needed and the length of the trial.

"We really wanted to make a push; we felt like it was a good idea to give academicians and people that aren't familiar with the regulatory process a pathway to develop these systems," Zimliki said. "We want people to move these things forward; we think this guidance will allow people t
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