Tags: diabetes | artificial | pancreas | FDA | guidance

FDA Issues Guidance on Diabetes Breakthrough

Friday, 02 Dec 2011 10:54 AM




Advocates of an artificial pancreas hailed as a breakthrough in treating type 1 diabetes were concerned that regulatory hurdles expected to be issued by the U.S. Food and Drug Administration would delay progress on the technology.

But those concerns have turned to praise as the FDA’s just-released guidance for testing the device in hospital and home settings appears to potentially speed up the approval process for the new technology.

The FDA guidance released Thursday marked a “milestone event” and “a huge opportunity for patients,” said Jeffrey Brewer, president and chief executive of the Juvenile Diabetes Research Foundation. The agency recognizes the importance of companies being able to move forward within a reasonable period of time, he added.

The artificial pancreas is worn outside the body and attached via catheter. It is designed to monitor blood sugar levels and dispense the right amount of insulin exactly when needed.

The estimated 3 million people in the U.S. with type 1 diabetes – in which the immune system destroys insulin-creating cells in the pancreas – have to closely monitor glucose levels or face deadly consequences. Getting just the right amount is tricky. Taking too little insulin raises glucose levels risking eye damage, kidney failure, and heart disease. Too much insulin lowers glucose levels, triggering hypoglycemia, which can lead to seizures, brain damage, and death.

“People are hurting themselves and killing themselves all the time with insulin,” said Brewer. “The data says one out of every 20 people with this disease might actually die with hypoglycemia.”

Medical device giant Medtronic CEO Omar Ishrak says there are about 10 years’ worth of technical and clinical hurdles yet to clear before the technology is available.

© HealthDay

 
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Friday, 02 Dec 2011 10:54 AM
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