Panel to Set Standards for New Continuous Monitors

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By: David Mendosa

It takes lots of work to make an effective continuousblood glucose monitor. It also takes performancestandards.

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

Those meetings will kick off next month whenthe performance standards panel will have itsfirst meeting. The panel’s name is a mouthful: theInternational Panel on Establishment of PerformanceStandards for Continuous Glucose Monitors. It willbe part of the Diabetes Technology Society’s fifthannual meeting November 10-12 in San Francisco’sAirport Hyatt Regency Hotel.

One meeting can’t solve anything as complex assetting performance standards, and they alreadyplan more meetings next year. Eventually, the panelwill submit its recommendations to the U.S. Foodand Drug Administration, which has the final wordon setting performance standards.

The panel’s membership is as broad as theperformance standards are deep. In addition tothe FDA itself, U.S. government representativeswill come from the Centers for Disease Control andPrevention, the National Institute of Standards andTechnology, and the U.S. Army.

And that’s not all. The panel will includerepresentatives from non-governmentalorganizations, universities, and hospitals as well asclinicians, statisticians, and companies developingcontinuous monitors. Participants will come not onlyfrom the U.S., but also from Canada, Europe, andAsia.

Accuracy will be the panel’s first focus. Continuousmonitors will provide much more data than theone-point meters we now use. So the panel will alsorecommend how we can best use this informationdeluge.

The panel “is the most important initiative inthe world to further the development of bettertechnology for people with diabetes,” says DavidKlonoff , M.D., who chairs the Diabetes TechnologySociety and its annual meetings. He is also editor-in-chief of the professional journal DiabetesTechnology & Therapeutics as well as clinicalprofessor of medicine at the University of California,San Francisco.

“Diabetes Technology Society’s purpose in creatingperformance standards in this industry is to simplifythe approval process for continuous glucosemonitors and increase the number of such productson the market for people with diabetes,” he says.“In many other industries, the establishment ofstandards has resulted in a surge of new productdevelopment after engineers learned whatperformance is required.”

Let’s wish them luck. If this panel’s work resultsin the FDA approving more continuous glucosesensors, we will all benefit.


The Society

There’s no better place for learning about thelatest developments in diabetes technology thanat the Annual Meeting of the Diabetes TechnologySociety. Only the American Diabetes Association holdslarger scientific meetings on diabetes.

The Diabetes Technology Society is a nonprofitorganization committed to promoting the applicationof science and engineering to the fight againstdiabetes. The society also presents the annualPeterson Student Research Award to the three topstudents conducting research in diabetestechnology, and the annual Diabetes TechnologyLeadership Award to the person who has donethe most to further the development of diabetestechnology.

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