The New York Times reports today that the rise in the use of home glucose monitors, also in hospitals, is pushing the Food and Drug Administration toward a possible crack-down on accuracy standards. Some of you might say it’s about time, considering that current standards allow a margin for error of up to 20%, which can make a huge difference in the choices we make on food, exercise, and in particular insulin doses.
And who among us hasn’t been frustrated by odd or inconsistent BG readings, or readings from different fingerstick meters that don’t seem to match up? (Don’t get me started on continuous glucose monitors!)
The NY Times reports that last month, the FDA started pressuring the International Organization for Standardization, which sets the standards,to tighten them. If that group refuses to act, the FDA “may instead recognize other (higher) performance standards” on its own, according to a June letter from agency commissioner Dr. Margaret Hamburg.
Get this: a recent study by government researchers comparing tests from five different popular meters found that results varied by as much as 32 percent. And a similar student project found “that almost all of the meters were off from one another by 60 to 75 points.” As a person who depends on my meter for health and well-being, all I can say to that is: O.M.G.
Quotable from the story:
“Manufacturers have long complained that any requirement to improve accuracy would lead them to raise prices, which would discourage use.”
Um, not so sure about that. Otherwise small competitors like AgaMatrix, with its WaveSense meters, wouldn’t be able to play in the market at all. In fact, this call-out is a great opportunity for the WaveSense folks, whose innovative new method for testing blood glucose is proven to be doubly as accurate as the industry standard — “by detecting and correcting errors caused by differences in blood samples and environmental conditions.” Their Jazz meter is also the only model on the market that calculates your glucose variability (standard deviation), “which many experts believe to be a better indicator of control than A1C testing.”
Not to blantantly plug the WaveSense guys here. But this FDA crack-down may be the wake-up call some of the big manufacturers need on improving glucose meter accuracy, finally. I’m just sayin’…