FDA Panel discusses “Artificial Pancreas” at Diabetes Technology Meeting

The 9th Annual Diabetes Technology Meeting held 5-7 November 2009 in Burlingame, CA drew a number of top diabetes researchers and covered a wide range of topics from the Artificial Pancreas, the Tour de France, FDA Artificial Pancreas DiabetesiPhones, gastric bypass surgery, and FDA efforts to facilitate research. The Blog made a brief appearance at a pre-conference workshop on the topic of current development in Clinical Trials, with an emphasis on Diabetes clinical trials.

Two regulatory scientists at FDA’s Center for Devices and Radiological Health (CDRH) were honored at the conference. Arleen Pinkos MT (ASCP) and Steven Gutman, MD were honored for the First Annual Artificial Pancreas award by conference chair Dr. David C. Klonoff. Dr. Gutman is the past director of the Office of In Vitro Devices (OIVD). He recently retired and now teaches at the University of Central Florida. Ms. Pinkos is the driving force for two FDA working groups on an Artificial Pancreas. One is an inter-agency working group and the other is an internal working group. They were honored for their role in moothing the regulatory pathway for innovative technologies such at the artificial pancreas which is sometimes referred to a “closed loop system.” Many of the presentations and posters covered developments for the artificial pancreas.

Many of the participants, including the Blog, are diabetics, and two interesting points were raised during a special FDA panel that discussed advances in the development of an artificial pancreas. Phil Southerland asked the Tour de France question of an FDA spokesman about advances in technology. It is Southerland’s ambition to particpate in the 2012 Tour. He is the founder of “TeamType 1,” which is found on the Blogroll under “Diabetes: TeamType1.” Amy Tenderich, of Diabetes Mine, mentioned the iPhone technology. Her website is found on the Blogroll at “Diabetes Mine.” In another interesting session, two European scientists discussed using telemedicine for the treatment of chronic health conditions, including diabetes. Telemedicine has yet to become common in the United States, primarily because of our health care structure.

The process of an artificial pancreas is still in the experimental stages. The devil,of course, is in the details, including effective software to determine dosage. Such a system is still years away from being marketed in the United States as safe and effective for its intended use. In fact one scientist speaking at the conference, Roman Hovorka, PhD, from Cambridge Unversity warned against use of the term stating that an artificial pancreas, or closed loop system is, “not a holy grail,” is an “evolving technology” that was not attainable in the immediate future.

The conference is sponsored by the Diabetes Technology Society, which publishes the Journal of Diabetes Science and Technology, whose editor is Dr. Klonoff the conference chair. The next meeting will be in November in Bethesda Maryland on 11-13 November 2010. Their website is on the Blogroll under Diabetes Technology.

You can read additional posts on FDA Commentaries here:



GxP Perspectives on LinkedIn


Special Notice: The Blog was published in the Journal of Diabetes Science & Technology on the topic of Supervisory Responsibilities of Investigators with my colleagues Ann Berenbaum and Patti Young.

Access the Abstract Here


2 Responses to FDA Panel discusses “Artificial Pancreas” at Diabetes Technology Meeting

  1. Picking a good pair of socks for diabetes is necessary for diabetic foot health.

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