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Setting Performance Standards for Continuous Monitors

By David Mendosa

Last Update: October 1, 2005

It takes lots of work to make an effective continuous blood glucose monitor. It also takes performance standards.

I have reported here on several continuous monitors in the works. But they won’t get far without an agreement on performance standards. And as bureaucratic as it sounds, agreeing on performance standards means meetings.

Those meetings will kick off next month when the performance standards panel will have its first meeting. The panel’s name is a mouthful: the International Panel on Establishment of Performance Standards for Continuous Glucose Monitors. It will be part of the Diabetes Technology Society’s fifth annual meeting November 10-12 in San Francisco’s Airport Hyatt Regency Hotel.

One meeting can’t solve anything as complex as setting performance standards, and they already plan more meetings next year. Eventually, the panel will submit its recommendations to the U.S. Food and Drug Administration, which has the final word on setting performance standards.

The panel’s membership is as broad as the performance standards are deep. In addition to the FDA itself, U.S. government representatives will come from the Centers for Disease Control and Prevention, the National Institute of Standards and Technology, and the U.S. Army.

And that’s not all. The panel will include representatives from non-governmental organizations, universities, and hospitals as well as clinicians, statisticians, and companies developing continuous monitors. Participants will come not only from the U.S., but also from Canada, Europe, and Asia.

Accuracy will be the panelŐs first focus. Continuous monitors will provide much more data than the one-point meters we now use. So the panel will also recommend how we can best use this information deluge.

The panel “is the most important initiative in the world to further the development of better technology for people with diabetes,” says David Klonoff, M.D., who chairs the Diabetes Technology Society and its annual meetings. He is also editor-in-chief of the professional journal Diabetes Technology & Therapeutics as well as clinical professor of medicine at the University of California, San Francisco.

“Diabetes Technology Society’s purpose in creating performance standards in this industry is to simplify the approval process for continuous glucose monitors and increase the number of such products on the market for people with diabetes,” he says. “In many other industries, the establishment of standards has resulted in a surge of new product development after engineers learned what performance is required.”

Let’s wish them luck. If this panel’s work results in the FDA approving more continuous glucose sensors, we will all benefit.

Sidebar: The Society
There’s no better place for learning about the latest developments in diabetes technology than the Diabetes Technology Society’s annual meetings. Only the American Diabetes Association has larger scientific diabetes meetings.

The Diabetes Technology Society is a non-profit organization committed to promoting the application of science and engineering to fight diabetes. The society also presents the annual Peterson Student Research Award to the three top students conducting research in diabetes technology and the annual Diabetes Technology Leadership Award to the person who has done the most to further the development of diabetes technology. 


This article originally appeared in Diabetes Health, October 2005, page 58..


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