The meter’s accuracy specs are outstanding, according to a white paper that founder and Chairman of the Board Sonny Vu sent me. Two studies with a total of more than 100 users and 10 different lots of test strips had 100 percent of its blood glucose readings in Zone A, which is the zone with no effect on clinical outcome. Meters from three other leading manufacturers did not do so well.
The study used the new Parkes Error Grid, which is replacing the older and still better known Clarke Error Grid. They checked blood glucose levels against the industry standard, the YSI 2000 STAT Plus blood glucose analyzer.
What makes such a high degree of accuracy possible is the company’s proprietary biosensor and dynamic electrochemical technologies. Other meters use static electrochemical or optical technology.
For at least four years I have been complaining about the woeful lack of meter accuracy. Back in 2002 when I wrote about the Food and Drug Administration’s lack of accuracy standards, I exposed what I still consider a scandal. There’s more background on the accuracy issue in a June 2002 issue of my newsletter.In 2003 I wrote about the accurate HemoCue 201 Meter (http://www.mendosa.com/accurate.htm), but it is only available to health care professionals. Earlier this year I wrote about the forthcoming HemoCue Monitor, which is accurate, but as far as I can tell isn’t available in the United States yet. The website for the HemoCue Monitor is, for one thing, still only available in Swedish, Finnish, and Danish.
Sonny Vu, the AgaMatrix chairman, sent me one of his company’s new Wave 1 meters, which just went on sale in April. I have begun to use it, and it compares well with the meter that I have been using recently, the Accu-Chek Aviva.
The Wave 1 meter, however, is considerably smaller. So too are its test strips. That’s good when you are traveling, although people with limited dexterity might well find the strips a little too small to handle easily.
Sonny says that the Wave 1 corrects for hematocrit levels and temperature. So it tests a few points higher than many other meters.
Even better, the Wave 1 is very fast and takes very little blood. The timing is somewhat variable, depending on blood glucose levels, Sonny says. But technically it is a fast as 4 seconds – and no other meter is faster than 5 seconds. The Wave 1 takes a 0.5 microliter drop of blood, less than almost any other meter.
Yet Sonny isn’t bragging about these numbers. “The specs are pretty standard,” he says. “They have become commodity features. The key feature of the Wave 1 is its accuracy. Our focus is to make a meter that is really safe and accurate.”
AgaMatrix knows technology and manufacturing, Sonny says. “We don’t know sales.”
That’s why U.S. sales are through Liberty Medical. Liberty is a wholly owned subsidiary of PolyMedica Corporation, the nation’s largest provider of blood glucose testing supplies and related services to people with diabetes.
The Wave 1 meter that Sonny sent me identifies AgaMatrix as the manufacturer. But it is labelled as a Liberty, not Wave 1 meter.
“We are considering other sales options,” Sonny says. “For now we just want to make sure that Liberty is happy.”
Actually, AgaMatrix made the Wave 1 to validate the technology. “But people said just to sell it, so we did.”
AgaMatrix has several models of Wave meters coming. Its website mentions a Wave 2 and a Wave 3. Product literature that Sonny sent me mentions KeyNote and Wave 1.5 meters.
The AgaMatrix motto is “The Wave is coming.” It may well be coming your way.
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