Panel Pressures FDA to Expedite Development of Artificial Pancreas

Posted by Brian Buntz on August 10, 2011

Almost 3 million people in the United States suffer from Type 1 diabetes, and the problem is steadily worsening. Last year, UnitedHealth Group predicted that half of all adults in the United States will have diabetes or prediabetes by 2020.

Cynthia Rice

To bring attention to the problem, the Juvenile Diabetes Research Foundation (JDRF) sent delegates to Congress on June 22, urging legislators to speed up R&D efforts to develop new treatment of the disease and accelerate approval of new treatment technologies and to find a cure for the disease.

“Some breakthrough tools and technologies that protect against dangerous diabetes episodes are already available all over the world, but are not available here in the United States,” testified Pam Sagan, a former JDRF board member, at another hearing on medical devices on July 20, which was held by the House Energy and Commerce Committee. For instance, low-glucose suspend systems have been approved in more than 40 countries outside of the United States. The device automatically suspends insulin delivery when blood sugar levels fall to dangerous levels.

Low-glucose suspend systems mark an important milestone towards the goal of developing an artificial pancreas, which could be especially beneficial in managing the disease. Capable of controlling both high and low blood sugar levels, the artificial pancreas is a closed-loop device that would combine the function of an insulin pump and a lowblood- sugar sensor. A computer algorithm would determine the appropriate amount of glucose in the blood and automatically pump insulin into the bloodstream to maintain that amount. An artificial pancreas would enable tighter control over the management of glucose levels than is possible using an insulin pump and a continuous glucose monitor in tandem. A recent study by O’Grady Health Policy predicted that the development of such a device could save Medicare almost $2 billion over the next 25 years.

FDA recently issued draft guidance for low-glucose suspend systems and committed to releasing artificial pancreas guidance by the end of 2011. “For many years, FDA was not clear about what studies manufacturers would need to conduct in order to receive approval for low glucose suspend systems in the United States,” explains Cynthia Rice, vice president of government relations for JDRF. “As recently as November 2010, when FDA hosted a public workshop on artificial pancreas systems, the FDA requirements were not yet clear. Thus, devices that were approved in Europe in 2008 are still not approved in the United States,” she adds. “The FDA recently took an overdue step to clarify the requirements for low-glucose suspend systems when it released a draft guidance on the topic on June 20.” —Brian Buntz

More on this issue is available in a blog post titled "What FDA Should Do to Facilitate New Diabetes Treatment."

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