FDA Scientists Recognized at Diabetes Technology Meeting

December 3, 2009

Applied Clinical Trials

Two regulatory scientists at FDA's Center for Devices and Radiological Health (CDRH) were honored at the 9th Annual Diabetes Technology Meeting held 5-7 November 2009 in Burlingame, CA. Arleen Pinkos MT (ASCP) and Steven Gutman, MD, were honored for the First Annual Artificial Pancreas award. 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 smoothing the regulatory pathway for innovative technologies such as the artificial pancreas that is sometimes referred to as a "closed loop system."

Briefly explained, an artificial pancreas is an experimental system that consists of: A) blood glucose readings taken by a continuous glucose monitoring system. The data is fed to B) software containing an algorithm that adjusts the dose of insulin according to the blood glucose reading, time of day, type of meal, time of last insulin dose, and other factors. These data then go to C) an insulin pump that administers the appropriate dose of insulin to the diabetic without the diabetic needing to take their own blood glucose test and administer the insulin. They don't even have to be awake. After the dose, and perhaps a meal, the sensor takes D) additional readings and an analysis of post-prandial blood glucose excursions and the process starts again. The four components, when working together effectively, form a "closed loop" that mimics the activity of a normally functioning pancreas without intervention by the diabetic. The devil, however, is in the details. 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 University warned against use of the term stating that a closed loop system is, "not a holy grail," but is an "evolving technology" that was not attainable in the immediate future.

The conference was noteworthy that an entire session was devoted to an FDA panel of Agency diabetes technology experts. Other topics raised included developing a blood glucose sensor that was part of an iPhone. Another meeting participant, who has Type 1 diabetes, asked an FDA panelist if the artificial pancreas could be approved in time for the 2012 Tour de France, which the participant intended to compete in. One FDA speaker, "Chip" Zimliki of CDRH, deftly sidestepped the question by noting that the Tour de France is outside the United States, and FDA's jurisdiction.

The conference is sponsored by the Diabetes Technology Society, which publishes the Journal of Diabetes Science and Technology, whose editor, David C. Klonoff, MD, FACP served as conference chair. The next meeting will be in November in Bethesda Maryland on 11-13 November 2010. For more information visit the website at: www.journalofDST.org.