JDRF says Pending Artificial Pancreas Guidance is FDA's Opportunity to Turn the Tide
NEW YORK, July 20, 2011 /PRNewswire-USNewswire/ -- The Juvenile Diabetes Research Foundation (JDRF) welcomed Congress's attention today to the important issue of medical device regulatory reform and reiterated the life-changing difference the FDA's pending artificial pancreas guidance will make in the lives of millions of individuals with type 1 diabetes across the country.
The hearing, "FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs," held before the House Committee on Energy & Commerce Subcommittee on Oversight and Investigations, highlighted the sense of urgency needed to accelerate the development and availability of emerging technologies for people with type 1 diabetes. Type 1 diabetes is an autoimmune disease that affects millions of Americans, must be managed 24-7 and can result in short- and long-term life-threatening complications.
"People with diabetes and their loved ones need timely access to innovative, life-saving technologies to help better manage the disease," said Pam Sagan, the mother of an adult daughter with type 1 diabetes and former JDRF board member, who testified at the hearing. "Some breakthrough tools and technologies that protect against dangerous diabetes episodes are already available all over the world, but not available here in the U.S.," added Sagan.
Low-glucose suspend systems have been approved for nearly three years and used safely in over 40 countries worldwide. These devices automatically suspend insulin delivery when blood sugar levels fall too low, thereby reducing the risk of hypoglycemia (dangerous low blood sugar), which is a significant and constant concern for people with type 1 diabetes. Low blood sugar levels can cause seizures, coma and even death.
"Proven technologies, such as low-glucose suspend systems, are waiting in the wings and already accessible outside of the U.S. Our nation is lagging behind in the approval of a device that would transform the lives of millions of individuals living with type 1 diabetes worldwide," said Jeffrey Brewer, President and CEO of JDRF.
During the testimony, Ms. Sagan stressed that "if the pattern continues, the next generation of these systems may be available in other countries years before they are available in America."
Low-glucose suspend technology is the first phase of an artificial pancreas, a combination of a continuous glucose monitor and an insulin pump with software that communicates between the two devices to automatically monitor glucose levels and administer insulin doses. Unlike the low-glucose suspend pump, the artificial pancreas would address both high and low blood sugar levels.
"This is a watershed moment for the FDA and our nation – an opportunity to be a leader in technology innovation and help revolutionize diabetes care," added Mr. Brewer. "The sooner the FDA releases clear and reasonable artificial pancreas guidance, the sooner patients will have access to a technology that holds the promise to drastically improve – and save – countless lives."
Ms. Sagan concluded, "I implore Congress to continue to urge the FDA to move forward urgently on next steps relating to low glucose suspend systems and the artificial pancreas, so that people with diabetes will remain healthier and safer until a cure is found. I want very badly to be an advocate for the work of the FDA. And I would lead the chorus of applause for the FDA when real progress happens, but it has to happen very soon. My daughter's life is depending on it."
About an Artificial Pancreas
The artificial pancreas is an external device, which people with type 1 diabetes could use to do what their bodies cannot—control both high and low blood sugar around the clock. It combines a continuous glucose monitor (CGM) and an insulin pump with sophisticated computer software to provide the right amount of insulin at the right time. Based on studies to date, JDRF expects first generation artificial pancreas systems to significantly improve glucose control. JDRF's ultimate goal is a system that would replace as closely as possible what is lost when an individual develops diabetes.
JDRF is the leader in research leading to a cure for type 1 diabetes in the world. It sets the global agenda for diabetes research, and is the largest charitable funder and advocate of diabetes science worldwide.
The mission of JDRF is to find a cure for diabetes and its complications through the support of research. Type 1 diabetes is an autoimmune disease that strikes children and adults suddenly, and can be fatal. Until a cure is found, people with type 1 diabetes have to test their blood sugar and give themselves insulin injections multiple times or use a pump – each day, every day of their lives. And even with that intensive care, insulin is not a cure for diabetes, nor does it prevent its potential and devastating complications, which may include kidney failure, blindness, heart disease, stroke and amputation.
Since its founding in 1970 by parents of children with type 1 diabetes, JDRF has awarded more than $1.5 billion to diabetes research, including $107 million last year. More than 80 percent of JDRF's expenditures directly support research and research-related education.
For more information, visit the JDRF web site at www.jdrf.org or call 800-533-CURE.
SOURCE Juvenile Diabetes Research Foundation