U.S. Senators, Clinicians and People with Type 1 Diabetes Urge FDA to Issue Clear and Reasonable Guidance on Artificial Pancreas
Washington, D.C. – U.S. Senators, clinical experts, and people with type 1 diabetes (T1D) today urged the Food and Drug Administration (FDA) to issue clear and reasonable guidance on the artificial pancreas (AP) that avoids unnecessary delays in development and delivery of a medical technology and improves the lives of millions of Americans living with this disease. Over 100,000 people have signed a petition to the FDA calling for swift action.
"The FDA has a real opportunity not only to foster innovation but also to help diabetes patients in the United States by issuing the draft guidance on time and by taking into serious account the scientific consensus on the safest and most rapid way forward," said Senator Susan Collins (R-ME). "The FDA guidance must truly lead to accelerated development and eventual regulatory approval of this key breakthrough technology which will ensure that those with type 1 diabetes can maintain better blood glucose control. Just last week in Italy and France, results from an outpatient trial for the artificial pancreas were announced. We need this innovation here in America."
"Many of us in Congress care deeply about type 1 diabetes, and know how life changing this technology could be for the millions of children and adults living with diabetes," said Senator Jeanne Shaheen (D-NH). "The FDA has promised to issue guidance for research by the end of this year. For the good of those families dealing with this disease, the FDA must honor that commitment."
The guidance is expected by December 1. Clinical experts say that the AP is the most revolutionary development in diabetes care since the discovery of insulin.
Collins and Shaheen, the Senate Diabetes Caucus Co-Chairs, were joined at a press conference by 11-year-old Caitlin Ryan, from Washington, D.C., who has T1D.
Additionally, at the press conference a petition of over 100,000 signatures urging the FDA to issue guidance by December 1 was unveiled. The signatures came from Americans across the country, including tens of thousands who live with T1D every day. 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 petition was posted on JDRFs website on October 3. In just over 20 days since its launch it has garnered over 100,000 signatures.
Last week in a letter sent to FDA Commissioner Margaret Hamburg, Sens. Collins and Shaheen advised the FDA to consider seriously the recent recommendations put forth by leading clinical organizations suggesting that the final AP guidance avoid the shortcomings of the recently proposed guidance for Low Glucose Suspend Systems, an AP precursor technology.
"The artificial pancreas is a life saving and game changing device for kids and adults living with type 1 diabetes," said Jeffrey Brewer, President and CEO of JDRF. "Research has demonstrated the dramatic impact the artificial pancreas would have – saving lives, transforming quality of life for people with type 1 diabetes and reducing preventable medical complications. However, if the FDA fails to issue guidance that adopts recommendations from leading clinical experts, patient access will inevitably be delayed and even prevented entirely. This is an opportunity for the FDA to demonstrate its commitment to meeting its goal of closing the agencys regulatory science gap."
On October 17, the American Diabetes Association, the American Association of Diabetes Educators, the Endocrine Society and the American Association of Clinical Endocrinologists sent a letter to FDA Commissioner Hamburg urging the FDA not to repeat the shortcomings of the Low Glucose Suspend decision. The letter stated, "The artificial pancreas has the potential to have more impact on diabetes care and patient health than any development since the discovery of insulin."
Specifically, the clinical organizations called on the FDA to ensure that the AP guidance contains the following critical elements:
- A firm commitment to use continuous glucose monitor (CGM) data in evaluation of artificial pancreas systems
- Reasonable study progression
- Flexibility with respect to endpoints, patient population, and safety elements
- Policies to encourage system improvements
JDRF, the leading patient group for type 1 diabetes adults, children, and families applauded the letter.
About the Artificial Pancreas
The artificial pancreas (AP) is 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 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.
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.
In its efforts to advocate to the FDA on behalf of those with type 1 diabetes and their families, JDRF released an advertisement in two leading newspapers that calls for clear and reasonable guidance that will help advance the development of artificial pancreas systems in the U.S.
For more information, please visit www.jdrf.org.