The U.S. Food and Drug Administration (FDA) has approved the first outpatient artificial pancreas trial in the United States, marking a critical development in the effort by JDRF and its allies to bring this innovative and lifesaving diabetes technology to people with type 1 diabetes.
The JDRF-funded study will test an artificial pancreas system’s ability to function outside of a hospital setting, and is similar to the current outpatient trials being conducted in Europe.
The study is part of the first outpatient trials using an approach developed by the JDRF-supported Artificial Pancreas Consortium, an international research group including teams from Montpellier University Hospital (France), the Universities of Padova and Pavia (Italy), and the Universities of Virginia in Charlottesville and of California in Santa Barbara (USA).
The approval of this milestone study follows a major 18-month long effort by JDRF and allies to ensure a clear and reasonable regulatory pathway for outpatient artificial pancreas studies, and ultimately for artificial pancreas systems to be approved and made available by the FDA. JDRF-funded studies have shown improved clinical outcomes from early trials of prototype artificial pancreas systems. In early 2011, JDRF proposed guidance to the FDA, based on recommendations from an external expert panel. In the following months, over 100,000 people in the diabetes community signed JDRF’s petition, and numerous leading clinical organizations, as well as over 60 Senators and 250 Representatives joined JDRF in urging FDA to act. The FDA met its promised deadline and released draft guidance for artificial pancreas systems on December 1, 2011.
JDRF recently completed an evaluation of the draft FDA artificial pancreas guidance, and submitted comments to FDA on March 3rd. JDRF believes that the draft contains many positive elements that will encourage research and development of artificial pancreas technologies and lead to their eventual availability in the U.S.
The development of an artificial pancreas is one of JDRF’s top priorities. JDRF and the National Institutes of Health’s Special Diabetes Program have funded groundbreaking work in recent years to advance its research and development.