First U.S. Outpatient Artificial Pancreas Trial Receives FDA Approval

The U.S. Food and Drug Administration (FDA) has approved the first outpatient artificial pancreas trial in the United States, marking a critical step in the effort by JDRF and its allies to bring this innovative and lifesaving diabetes technology to people with T1D. 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. These studies are evaluating an algorithm that will minimize the time spent in the low and high blood sugar ranges using continuous glucose monitoring (CGM) and an insulin pump in individuals with T1D. An artificial pancreas device with this software would maintain blood sugar within a target range between, for example, 80 mg/dL and 180 mg/dL, by automatically increasing insulin delivery when it senses blood glucose going above the high end of the range, and slowing down or turning off insulin delivery when it senses blood glucose levels moving below the low end of the range. The wearer would still need to manually tell the pump to deliver insulin at meal times and adjust insulin delivery rates based on activity, illness, and other variables. The research team is using already-approved insulin pumps and continuous glucose monitors, which were controlled by a hand-held device (the development of which was partially funded by JDRF) created at the University of Virginia by a team led by Drs. Boris Kovatchev and Patrick Keith-Hynes and monitored by the investigators at all times to ensure safety. These pilot clinical studies are aimed at the stepwise deployment and testing of the hardware and software components leading to a pivotal trial of a system that will be run by a cell-phone-type device communicating with CGM sensors and insulin pumps and will be suitable for long-term use at home.

Reference:

JDRF Press release http://www.jdrf.org/index.cfm?page_id=117007 and PI communications.

Ramifications for Individuals with T1D:

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 inpatient trials of prototype artificial pancreas systems.

JDRF Involvement:

The development of an artificial pancreas is one of JDRF’s top priorities. JDRF and the National Institutes of Health’s Special Diabetes Program (SDP) have funded groundbreaking work in recent years to advance its research and development.