Advocates, 150 Children With Type 1 Diabetes Urge FDA to Enable Critical Research on Life-Saving Artificial Pancreas to Move Forward

Concerns about progress, patient access voiced at Senate hearing for JDRF's Children's Congress

WASHINGTON, June 22, 2011 /PRNewswire-USNewswire/ -- Kevin Kline and four children with type 1 diabetes urged the Food and Drug Administration (FDA) to take immediate action to accelerate the research and review of artificial pancreas systems at a hearing before the Senate Committee on Homeland Security and Government Affairs. The hearing, "Transforming Lives through Diabetes Research," was part of the Juvenile Diabetes Research Foundation's (JDRF) 2011 Children's Congress, a biennial, three-day event aimed to raise awareness for type 1 diabetes and the importance of Congressional leadership to help accelerate research to cure, treat and prevent the disease.

"The testimonies given today served as a call to action for Members of Congress to continue their support for type 1 research funding and ensure agencies like FDA are doing their part to speed the review and approval of safe and effective therapies and treatments like the artificial pancreas that will help to lessen, and ultimately eliminate the burden of type 1 diabetes," said Jeffrey Brewer, president and CEO of JDRF.

The hearing came on the heels of a recent announcement from FDA, releasing draft guidance on "Low Glucose Suspend" systems, which reduce the risk of low blood sugar, for public comment. The announcement was a long-overdue, but important first step towards the future availability of the artificial pancreas, as the 3 million people living with type 1 diabetes are in desperate need for better tools to manage the disease and prevent its life-threatening complications.

"I know FDA has made the artificial pancreas a priority, and I commend the agency for that. But there is more the FDA needs to do," said Kevin Kline, Celebrity Advocate Co-Chairman, JDRF.  "Many of these children here today are wearing the components of an artificial pancreas – insulin pumps that deliver insulin and continuous glucose monitors which give sugar readouts every few minutes.  The challenge, however, is that these devices don't yet work together to automatically control their blood sugar levels.  In other countries, there are devices available that take the first step by automatically shutting off the insulin pump when someone is low."

At the same time, studies on the next generation artificial pancreas systems – which turn insulin both on and off automatically – are delayed and JDRF and numerous clinical experts are urging FDA to take immediate action to allow outpatient studies to proceed. The artificial pancreas is a transformational technology and one that is urgently needed by patients. Numerous published, peer reviewed studies conducted in hospital settings have shown that even early versions of an artificial pancreas can significantly improve glucose control for type 1 diabetes. Additionally, advancing the artificial pancreas could prevent costly complications that are burdening our economy – a new study by leading health economics experts shows an artificial pancreas could save Medicare nearly $2 billion over the next 25 years.(1) And leading clinicians and researchers from around the country along with a bipartisan majority of Congress have voiced their support for FDA to take the next steps in the regulatory process toward the development of an artificial pancreas. The letters of support can be found here.

JDRF's goal is to find a cure for type 1 diabetes. But there are transformational treatments, such as an artificial pancreas, which could help individuals live better with type 1 diabetes today and keep them healthy until that cure is found.  The FDA must provide clear and reasonable guidance for the next step in the testing of artificial pancreas systems to ensure these devices are brought to market as quickly as possible.

"After participating in clinical research since I was three years old, I can honestly say the closed loop artificial pancreas trial was the most amazing experience of my entire life and holds so much promise for people living with this disease," said Kerry Morgan, a 17-year-old JDRF Children's Congress delegate from Glen Allen, Virginia who testified today.

Mary Tyler Moore, JDRF International Chairman submitted a written testimony which stressed that "We need immediate action by the FDA to ensure the artificial pancreas can move to the next stage of testing – if not, this promising technology could be delayed for years and available overseas long before it is available in the U.S., as some technologies already are. I know that if I had had an artificial pancreas 40 years ago, I would likely not be facing such a heavy burden of complications as I do today."

The witnesses also thanked the Senators for their support of funding for diabetes research, highlighting progress in areas such as understanding the genetic and environmental causes of the disease, trials testing ways to halt the immune attack which causes type 1 diabetes, and new eye therapies to prevent vision loss.

"We have an opportunity in this country to be a leader in the development of a technology that will transform the day-to-day management of type 1 diabetes and reduce the risk of the devastating long-term complications for the millions living with this disease," added Brewer.

Today's hearing was chaired by Senator Susan Collins (R-ME), co-chair of the Senate Diabetes Caucus and a long-time champion for diabetes research.  Others who testified included Dr. Griffin Rodgers, Director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health; Dr. Charles Zimliki Chair, Artificial Pancreas Critical Path Initiative, Food and Drug Administration (FDA); and four children and teens with type 1 diabetes. They included Caroline Jacobs, 14, from Shapleigh, Maine; Jack Schmittlein, 13, from Avon, Connecticut; Kerry Morgan, 17, from Glen Allen, Virginia; and Jonathan Platt, 7, from Tarzana, California. Testimonies from the hearing will be posted on the JDRF web site.  

About JDRF

JDRF is the worldwide leader for research to cure type 1 diabetes. 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. 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 complications, which may include kidney failure, blindness, heart disease, stroke, and amputation.  JDRF estimates that there are as many as three million people in the United States who have type 1 diabetes.  

(1)  O'Grady, Michael J. Ph.D., Priya M. John MPH, Aaron Winn, MPP. "Changes in Medicare Spending for Type 1 Diabetes With the Introduction of the Artificial Pancreas." June 9, 2011.

SOURCE Juvenile Diabetes Research Foundation