The FDA has approved the first outpatient artificial pancreas trial in the U.S., which will be funded by JDRF, a global organization focused on type 1 diabetes research.
The study will test an artificial pancreas (AP) system's ability to function outside 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 in France, the Universities of Padova and Pavia in Italy, the University of Virginia in Charlottesville and University of California in Santa Barbara.
"While this is a small feasibility study, this is a major step forward in the field of artificial pancreas research and we congratulate the researchers and the FDA on this important milestone,” said Aaron Kowalski, Ph.D., assistant vice president of treatment therapies, JDRF.
The approval of the 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 AP systems to be approved and made available by the FDA. JDRF-funded studies have shown improved clinical outcomes from early trials of prototype AP systems
In December 2011, the FDA met its promised deadline and released draft guidance for AP systems. JDRF recently completed an evaluation of the draft FDA AP guidance, and submitted comments to FDA on March 3, 2012. JDRF believes that the draft contains many positive elements that will encourage R&D of artificial pancreas technologies and lead to their eventual availability in the U.S.
"While there were some areas of concern in the guidance, we have begun a dialogue with FDA about these issues, and we will continue to urge the agency to revise these in the guidance before it is finalized so that we will continue to see more outpatient trials approved, and people with diabetes will ultimately have access to these lifesaving technologies as soon as possible," added Kowalski.
JDRF and the National Institutes of Health's (NIH) Special Diabetes Program have funded groundbreaking work in recent years to advance AP system research and development.