Diabetes Testing

China’s GlucosePilot

The first blood glucose meter made in China for the U.S. debuted at last month’s American Diabetes Association’s 66th Scientific Sessions in Washington, D.C. Now, I wonder how long it will be before cars and trucks made in China take over the American market.

The meter is the GlucosePilot, and the Food and Drug Administration approved it last December. The manufacturer is Tianjin New Bay Bioresearch Company Ltd in Tianjin, China. I don’t remember ever hearing about Tianjin before, but it is China’s third largest city with a population of more than 10 million people.

Americans use most of the world’s blood glucose meters. The first of these meters came from Elkhart, Indiana, in the American heartland.

However, the inventor of the first such meter was Anton Hubert (Tom) Clemens, who applied for the first patent in 1968, just two years after arriving in the U.S. from Switzerland.

Blood glucose meters are now made around the world. A company in Hungary, 77 Elektronika Kft., has probably made more different meters than any other company.

Probably nothing illustrates the internationalization of blood glucose meters better than the origin of the four new meters presented at the ADA convention. Besides China’s GlucosePilot, the other three meters came from Taiwan, from Germany, and – last but not least – from the United States.

I wrote about the meter from Taiwan in my previous blog entry. When I get samples of the German and American meters, I will also review them.

An American company, Aventir Biotech LLC in Carlsbad, California, distributes the GlucosePilot. They kindly sent me one.

The GlucosePilot has excellent specs. It takes just a 1 microliter drop of blood and returns a result in only 5 seconds.

But this meter’s apparent lack of accuracy disappointed me. I compared it with two meters that I have good reason to believe are quite accurate – the Accu-Chek Aviva and the Rightest GM300. In simultaneous tests comparing all three meters the readings that the GlucosePilot gave me varied from 132 to 136 mg/dl (7.3 to 7.6 mmol/l), while the readings from the Aviva and the Rightest never moved more than 1 point from 119 mgl/dl (6.6 mmol/l).

A few tests on one person are, of course, not conclusive proof, especially given the documentation that the company gave me. Comparisons of 280 tests from the GlucosePilot with the industry standard lab instrument, the YSI 2300 Stat Plus glucose analyzer, exhibited a 98 percent correlation.

The GlucosePilot is a basic meter. It lacks a computer port, although few people with diabetes use computer software to track their numbers. The chief financial officer of one meter company told me recently that less than 2 percent of us do that, and I don’t doubt that the number is in that range.

The test strips that the GlucosePilot use are about the smallest I’ve ever seen. They could be too small for people with limited dexterity.

All this might mean that the GlucosePilot meter and strips could have a quite affordable price. I don’t know yet.

“We are in the middle of developing a marketing strategy for the U.S. market,” Marketing Director Jerry Lee wrote me yesterday. “We haven’t set a suggested retail price for our distributors at this moment.”

If Aventir Biotech sets the price of the GlucosePilot low enough there could still be a market for it here. Isn’t that the way China grabs a foothold in most markets?

This article is based on an earlier version of my article published by HealthCentral.

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