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Entries in Artificial Pancreas (3)

Thursday
Dec012011

FDA Outlines Plan for Artificial Pancreas Approval

Jupiterimages/Thinkstock(WASHINGTON) -- The U.S. Food and Drug Administration Thursday issued guidance for scientists and device manufacturers seeking approval for the artificial pancreas --  a portable device to help people with type 1 diabetes control their blood sugar levels.

The draft guidance offers design and testing recommendations aimed at easing the approval process while still meeting statutory requirements for safety and effectiveness. It comes less than a month after lawmakers, health professionals, advocacy organizations and patients lobbied for expedited approval of the device.

"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.

Jeffrey Brewer, the president and CEO of the Juvenile Diabetes Research Foundation (JDRF), has a very personal reason for wanting the FDA to expedite their review of the artificial pancreas. His son has type 1 diabetes, meaning his body doesn't produce insulin. Type 1 diabetics either have to self-administer insulin or use pumps that release insulin throughout the day.

"Diabetics have to self-prescribe insulin all day long, and they can makes mistakes and occasionally kill themselves," he said. "My son almost died because he gave himself too much insulin. The insulin pump didn't have the right features to shut off insulin delivery."

According to JDRF, as many as three million Americans may have type 1 diabetes, and Brewer said the artificial pancreas can potentially save those people's lives.

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.

One of the sticking points that could potentially delay the device's approval is the fact that continuous glucose monitors are not approved to provide insulin dosages, only to alert a person that blood sugar is high or low.

"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.

Zimliki, a type 1 diabetic himself, said he wants the device to be approved as quickly as possibly.

"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 Thursday. "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."

Copyright 2011 ABC News Radio

Thursday
Nov032011

Major Push for Quicker Approval of Artificial Pancreas

Jeffrey Hamilton/Lifesize/Thinkstock(WASHINGTON) -- Jeffrey Brewer, the president and CEO of the Juvenile Diabetes Research Foundation (JDRF), has a very personal reason for wanting the U.S. Food and Drug Administration to expedite their review of the artificial pancreas -- a portable device used to help people with type 1 diabetes control their blood sugar levels through the use of an insulin pump, a continuous glucose monitor and computer software.

Brewer's son has type 1 diabetes, meaning his body doesn't produce insulin.  Type 1 diabetics either have to self-administer insulin or use pumps that release insulin throughout the day.

"Diabetics have to self-prescribe insulin all day long, and they can makes mistakes and occasionally kill themselves," he said.  "My son almost died because he gave himself too much insulin.  The insulin pump didn't have the right features to shut off insulin delivery."

According to JDRF, as many as three million Americans may have type 1 diabetes, and Brewer said the artificial pancreas can potentially save those people's lives.

But the FDA, he said, has been slow in moving along the approval process.  In an effort to expedite bringing the product to market, JDRF, Sens. Susan Collins (R-ME) and Jeanne Shaheen (D-NH), health professionals, and individuals with type 1 diabetes gathered in Washington, D.C., on Wednesday to urge the FDA to take quicker action.

Brewer said their goal is to encourage the FDA to implement policy changes and guidance that will allow devices to get to market faster and also allow for research into new products to help with insulin control.  The FDA, in response to the criticism, says it is eager for the product to be available, but it needs to be sure it is safe and effective for consumers.

"FDA policies have delayed introductions of products such as the artificial pancreas to Americans by up to three years that are being safely used by people around the world with type 1 diabetes, and they prevent us from doing vital research in the U.S.," said Brewer.

The FDA is currently preparing recommendations for getting the artificial pancreas approved for use in the U.S., but Brewer said the agency's advice -- called draft guidance -- delays the approval process and doesn't take the recommendations of experts into account.

The meeting in Washington is another of JDRF's efforts to push the FDA forward.  The group also took out full-page newspaper ads and posted a petition on its website.  That petition, JDRF said, received more than 100,000 signatures in only three weeks.

Copyright 2011 ABC News Radio

Thursday
Apr142011

Artificial Pancreas Trials Reduce Low Blood Sugar Risks

Jeffrey Hamilton/Thinkstock(CAMBRIDGE, England) -- While investigating the effectiveness of an artificial pancreas for the management of type 1 diabetes, British researchers observed an improvement in blood sugar control and found that they could reduce the risk of dangerously low blood sugar levels while patients sleep.

The study's lead author, Roman Hovorka, a principal research associate at the University of Cambridge in the UK, and his colleagues are one of several teams trying to develop a successful artificial pancreas, known as a closed loop system.

The artificial organ essentially combines existing technology intended to manage diabetes, such as insulin pumps and glucose monitors, with a computer algorithm that instructs the devices to act accordingly when blood sugar levels rise or fall.

Researchers working to develop such a system hope to produce an artificial pancreas that functions very similarly to a real pancreas, with the ability to release insulin in response to food or stress.

The study's findings were published online in the British Journal of Medicine.

Copyright 2011 ABC News Radio







ABC News Radio