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 FDA Releases New Guidelines to Speed Up

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Registration date : 10/08/2011

Bài gửiTiêu đề: FDA Releases New Guidelines to Speed Up   Mon Dec 05, 2011 1:36 am

Artificial pancreas devices are not a cure, but combine a glucometer and insulin pump to make the lives of type 1 diabetics easier

In an effort to speed up the development of artificial pancreas systems for type 1 diabetes treatment, the U.S. Food and Drug Administration (FDA) issued new guidelines Thursday that could give researchers and industry more flexibility in creating safe and effective diabetic devices.

Type 1 diabetes is the result of the pancreas creating little to no insulin, which is a hormone required to control blood sugar. Type 1 diabetics typically control their blood sugar by testing blood glucose levels via a glucometer, and then use a syringe or insulin pump
to appropriately inject the correct amount of insulin needed.

But now, artificial pancreas devices are meant to make life easier for type 1 diabetics. The system combines an insulin pump and a glucometer via a sensor underneath the skin, which works continuously while in the body. The glucometer checks blood glucose levels and communicates these numbers to the insulin pump, which then distributes the correct amount of insulin to keep blood sugar at a normal range.

The FDA has released new guidelines meant to speed up the development and testing of these products, which were based on a draft guidance on safety and effectiveness goals in developing the Low Glucose Suspend System back in June.

"We really are trying to get these devices to the market as quickly as possible," said Charles Zimliki, leader of the FDA's Artificial Pancreas Working Groups and Critical Path Initiative. "Hopefully it [approval for one or more devices] will happen sooner rather than later. As a person with type 1 diabetes, I hope it happens tomorrow."

The guidelines offer recommendations on how to conduct testing, but are more flexible when it comes to number of patients involved, the length of the study and study goals. This will make it easier for researchers to put a safe and effective device on the market sooner.

There's no clear date when the first artificial pancreas will be available, but there are definitely a few obstacles that need to be addressed before a device can hit the market including software issues, problems creating algorithms to send insulin that take into account the period of time needed for the body to absorb it, the need for faster-acting insulin, and the need to occasionally recalibrate blood sugar monitors.
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