Soon we will be able to test our A1C at home again. Right now if you want to track your A1C, you will need to go to your doctor's office or a lab that your doctor sends you to or mail in one of the test kits.
Until the end of last year Metrika Inc. in Sunnyvale, California, made a home A1C meter. They sold the device as the A1CNow and as the ChoiceDM A1C that they made for Bristol Myers.
The A1CNow was a single-test system. After testing your A1C once, you threw the device away. This always seemed wasteful and offended my environmental sensitivities.
This July, Bayer Diabetes Care bought Metrika. They are already selling a professional version of their new home A1C meter, now called the A1CNow+. This new system is comprised of two major parts, a multi use readout device and a single use test cartridge that you insert into the readout device. The professional package is comprised of one of the readout devices and ten individual test cartridges.
Sunil Hazaray, the senior vice president, global sales and marketing of the A1CNow division of Bayer, says that the new test will require just 5 microliters of blood, down from 10 previously. It takes 5 minutes, down from 8. It is also improved in other ways from the original A1CNow.
"They are similar, but not identical," Sunil told me. The chemistry is the same, but the electronics and software are much improved.
He sent me a professional kit, which the Food and Drug Administration has approved and is already available to doctors.
"They are sold only through medical and surgical distributors, who would not likely sell one to consumers," Sunil told me. However, one of my correspondents, Rich in Missouri Valley, Iowa, just used his connections to get a professional kit.
"The new test system is easier to use than the old device," Rich told me. "I do not know about the accuracy, but I will have a better idea in six weeks, when I run the next test. It is in the range that I expected though, so it is probably real close, if not right on."
Rich says that he closely follows his A1C trend in order to head off problems. He has been maintaining 5.3 to 5.6 readings with the old units and says that has a couple of local lab points which are lower by 0.4.
"I suspect that there are several of us who are interested in tracking our A1C more often than once or twice a year and do not have insurance to pick up the bill," Rich told me. "The local clinic got to me for almost $180 for the last one they did. That included the obligatory 15 seconds with the doctor. I have done enough lab work that doing this at home is no challenge and about $160 cheaper. I can get the VA to do one a year for a lab marker data point, so I find these home test kits to be a real bargain."
Like Rich, my wife found that the Metrika device tests higher than her lab values. When I tested her A1C on September 11, the result was 8.2. The next day at our doctor's office her result was 7.8. Our doctor, Jeffry N. Gerber said that the difference was acceptable and within a normal margin of error.
When I used the Metrika device to check my A1C on September 15, my A1C result was 6.3. This is probably right on, since my A1C is trending down as I continue to lose weight on Byetta and the most recent A1C test I had at Dr. Gerber's office was 6.4 on August 7.
The home version of the A1CNow+ system will come with two test cartridges. It won't be available until July. Why so long a wait?
The FDA has approved it, Sunil told me. But they are still working on keeping it stable. Right now it is only stable for 3 months at room temperatures, and they require a year to 18 months, he says, especially since it will be in pharmacies.
The American Diabetes Association recommends that we get an A1C test every three months if our levels are above 7.0 and every six months if they are below 7.0 or whenever our treatment changes or we have elevated blood glucose levels.
The Diabetes Control and Complications Trial and the United Kingdom Prospective Diabetes Study were the two biggest and most important studies of people with diabetes ever. Both studies showed that lower A1C values are associated with the prevention of or significant decreases in the development of serious eye, kidney, and nerve disease.
The American Association of Clinical Endocrinologists (AACE) sets the target lower than the ADA's 7.0. The AACE says it should be below 6.5 percent. People who don't have diabetes have A1C levels of 6.0 percent or less.
How much less than 6.0 is normal? The Professional-use Product Insert that came with the new Metrika device has the best answer to that question I have ever seen.
"The expected normal range for percentage A1C using the A1cNow system was determined by testing blood samples for 118 presumptively non-diabetic individuals."The mean A1C result was 5.2%... These values are similar to those reported in the literature."
The A1C isn't everything. There are other tests.
These alternative tests of blood glucose levels over a period of weeks include the GlycoMark test from the BioMarker Group in Winston-Salem, North Carolina. At one time LXN Corp. in San Diego offered a fructosamine test with its now discontinued In Charge meter. The forthcoming Epinex G1A test of glycated albumin from Epinex Diagnostics Inc. in Irving, California, may be another option.
All of these tests are averages, and averages can hide wide extremes. In particular, the A1C can hide what people are beginning to call glycemic excursions. There aren't any tests that measure these excursion yet, but continuous sensors like the DexCom STS, the Minimed REAL-Time, and the forthcoming FreeStyle Navigator can help you reduce them.
But the A1C remains the standard, and the Metrika A1CNow+ device is the most convenient way to make that test. The A1C test may not be sufficient, but it still is the most necessary measure of blood glucose control that we have.