The petition was launched on JDRFs website on October 3 and delivered to the FDA today.
"This incredible groundswell of support should not be ignored by the FDA," said Jeffrey Brewer, president and CEO of JDRF. "The development of artificial pancreas systems is a top priority for kids and adults living with type 1 diabetes. Research has demonstrated the dramatic impact the artificial pancreas could have – saving lives, transforming quality of life for people with type 1 diabetes and reducing preventable medical complications. Thats why so many people touched by this disease quickly responded in a massive way to urge the FDA to take this opportunity and issue guidance that will accelerate the development of this much-needed technology."
The signatures come from Americans in every state across the country, whose lives are affected by T1D on a daily basis. The petition signers called on the FDA to "adopt outside clinical recommendations allowing short term in-hospital evaluation of artificial pancreas systems followed by outpatient trials no more than three months long."
"The FDA owes it to the diabetes community to issue guidance that honors the petition of the 100,000 signers," said Brewer. "If the FDA fails to issue guidance outlined in this petition, patient access will inevitably be delayed. Today Americans are deprived of potentially life-saving insulin pumps with safety features like low glucose suspend, available in the rest of the world for more than 3 years. We dont want to see the same happen with artificial pancreas systems in the future."
About the Artificial Pancreas
The artificial pancreas (AP) will be an external device which people with T1D could use to do what their bodies cannot-control both high and low blood sugar around the clock. It works by combining a continuous glucose monitor (CGM) and an insulin pump with sophisticated computer software to provide automatically the right amount of insulin at the right time.
One of JDRFs top priorities is the development of the artificial pancreas (AP). JDRF funded studies have shown greatly improved clinical outcomes from early clinical trials of prototype AP systems. In order for AP systems to be further developed, tested in outpatient pivotal trials, and approved for people with T1D, the FDA needs to provide clear and reasonable artificial pancreas guidance.
The petition is part of a campaign by JDRF to advocate to the FDA on behalf of those with T1D and their families.
JDRF is the leading global organization focused on type 1 diabetes (T1D) research. Driven by passionate, grassroots volunteers connected to children, adolescents, and adults with this disease, JDRF is the largest charitable supporter of T1D research. The goal of JDRF is to improve the lives of every person affected by T1D by accelerating progress on the most promising opportunities for curing, better treating, and preventing T1D. JDRF collaborates with a wide spectrum of partners who share this goal. Since its founding in 1970, JDRF has awarded more than $1.5 billion to T1D research. More than 80 percent of JDRF's expenditures directly support research and research-related education. Past JDRF research efforts have helped to significantly improve the care of people with this disease, and have expanded the critical scientific understanding of T1D. JDRF will not rest until T1D is fully conquered.
For more information, please visit www.jdrf.org .