The A1CNow meter for checking the key level of sugar in our blood is back. Chek Diagnostics, which changed its name from Polymer Technology Systems on March 27, just started shipping this meter that lets us check our A1C level at home.
I reported here on December 24 in "A Christmas Gift to People with Diabetes with Polymer" that the company had purchased the A1CNow business from Bayer Diabetes Care.
During the transition in ownership the availability of the A1CNow meter became spotty. Fortunately, the new owners didn't change the device or its name. It is fortunate because they didn't have to wait for the long approval process that the U.S. Food and Drug Administration requires for new and revised devices.
"We have not made any changes in the device," Bob Huffstodt, President and CEO of Chek Diagnostics, told me yesterday. "We made sure to get up and running and supply the market with the product before we even contemplated any changes. Of course, we did change the branding on the box simply because we can't use the Bayer trademark, nor would we want to do so. The product name is still the A1CNow+ (or the A1CNow SelfCheck in its consumer configuration). But the company name is of course no longer Bayer; it is Chek Diagnostics."
Likewise, the National Hemoglobin Standardization Program, or NGSP, continues to certify the A1CNow, according to Mr. Huffstodt and the "List of NGSP Certified Methods." To the best of my knowledge and that of Mr. Huffstodt, the A1CNow is the only home A1C device that is certified compatible. This means that its results are comparable to those reported in the Diabetes Control and Complications Trial (DCCT), where the relationships between blood glucose levels and the risk for vascular complications have been established. The DCCT is the gold standard for reliable diabetes testing.
The site where Bayer manufactured the A1CNow was in Sunnyvale, California, and remains there under Chex Diagnostics ownership, although the headquarters of Chek Diagnostics is in Indianapolis, Indiana. "It was an asset-based transaction," Mr. Huffstodt says, "so we acquired all of the operating assets, equipment, non-Bayer branded inventories, the intellectual property, and the know-how that was required to restart the business."
Chek Diagnostics is selling the A1CNow through distributors around the world, rather than directly. The price to us will probably be a bit higher. Pharmacies around the country had been selling a set of two test units of the A1CNow SelfCheck for $30 to $40.
But since I use an A1CNow+ unit to check my level on the first day of every month, I purchased a 10-pack kit (1 monitor and 10 test cartridges). I got them from A1CTest for $129.00 plus $10.95 shipping and handling. That site's current price is $159.00 plus $10.95 for shipping and handling.
Update May 1: The owner of A1CTest, Steve Freed, tells me that his company will sell you the 10-pack kit for $129.00 plus $8.95 postage if you mention my name or this article when you call or email them.
If you test as often as I do, the A1CNow+ makes sense. Otherwise, the A1CNow SelfCheck is the way to go.
My most recent test with the A1CNow at the first of this month was 5.1%. It matters how accurate the test is. According to a FAQ on the Chek Diagnostic website, "Study results with healthcare professionals showed that the accuracy of A1CNow+ with fingerstick samples was, on average, 99%. This means that, on average, a true 7.0% A1C could read approximately 6.9% A1C. An individual A1CNow+ result may differ by as much as -1.0% A1C to +0.8% A1C from the true result." That's a tight margin of error.
With the A1CNow we can find out how we are managing our diabetes in just five minutes. The test requires a 5-microliter drop of blood, and its cartridges have a 15-month shelf life. As Steve Edelman, MD, the founder and director of Taking Control of Your Diabetes says, the big advantage of the A1CNow is that it "allows people with diabetes to test their A1C level in the comfort and privacy of their own home -- to get the information they need to manage their disease between health-care provider visits."