Saturday, March 24, 2012

Artificial Pancreas Trial Approved

FDA recently approved the first outpatient artificial pancreas trial in the U.S. that will test a device to be used by individuals with Type 1 diabetes. The hand-held device was created by reconfiguring a standard smart phone capable of automatically monitoring blood sugar levels and providing insulin as needed. It works by combining a continuous glucose monitor and an insulin pump complete with sophisticated computer software that automatically provides the right amount of insulin at the right time.

The development of an artificial pancreas has been one of JDRF’s top priorities and the Foundation in working with NIH’s Special Diabetes Program has funded groundbreaking work in recent years to advance the research and development of the device.

As part of the study, the first outpatient trials used an approach developed by the JDRF- supported Artificial Pancreas Consortium. This international research group worked together with teams from Montpellier University Hospital in France, the Universities of Padova and Pavia in Italy, and the Universities of Virginia in Charlottesville.

The first eight Type 1 diabetes patients participating in outpatient trials in Europe were able to maintain safe blood sugar levels using the artificial pancreas, able to eat a restaurant meal, and able to spend one night at a hotel while using the device.

The approval of the JDRF study follows a major 18 month effort by JDRF and others 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.

In early 2011, JDRF proposed guidance to the FDA based on recommendations from an external expert panel and where over 1000,000 people in the diabetes community signed JDRF’s petition seeking approval from FDA. In addition, the petition was signed by leading clinical organizations as well as over 60 Senators and 250 Representatives. The FDA met the deadline and released the draft guidance for Artificial Pancreas systems in December 2011.

JDRF recently completed an evaluation of the FDA draft guidance for Artificial Pancreas systems and submitted further comments to FDA on March 3rd. JDRF is happy to report that the draft contains many positive elements that will encourage research and development for the artificial pancreas so that the technology will become available in the U.S.