Anyone who has been trying to control his or her diabetes for more than a few days often gets disappointed with checking blood glucose levels. Our disappointment is sometimes not how high those levels go but how erratic our meters and test strips seem to be behaving.
Meter accuracy is a pain — an emotional pain that can be more than the physical pain of lancing. Just which meter systems are accuracy?
That’s probably the question that people newly diagnosed with diabetes ask me the most. And now for the first time we have the beginning of an answer.
In my 15 years of following diabetes developments I haven’t seen a single scientific comparison of the blood glucose meters that we have to work with. Until now.
And now we have a study that compares meters from the major brands as well as some minor ones. The study compared 27 blood glucose monitoring systems including systems from the big four on the American market, LifeScan, Roche, Bayer, and Abbott. These are the four companies that seem to have a lock on reimbursement from almost all medical insurance plans.
Strangely, the study appears without fanfare. I only learned about it from an executive of i-SENS, the Korean meter manufacturer that invited me to visit South Korea last month. i-SENS makes blood glucose meters and test strips for many other companies that sell them under their own names, and I don’t know which, if any, of the meter systems that the new study evaluated came from i-SENS.
The study appeared in the February 2010 issue of Diabetes Technology & Therapeutics as “System Accuracy Evaluation of 27 Blood Glucose Monitoring Systems According to DIN EN ISO 15197.” Even better news is that this journal’s publisher, Mary Ann Liebert Inc., is providing complimentary online access to the full-text of three of its publications through the end of November in honor of World Diabetes Day, which was on November 14. In addition to Diabetes Technology & Therapeutics, this includes Metabolic Syndrome and Related Disorders and Childhood Obesity. You can read the full-text of the meter accuracy study at http://www.liebertonline.com/doi/pdfplus/10.1089/dia.2009.0128.
At first glance the study may not appear relevant to Americans, because it evaluates the systems according to European standards. But the fact is that the U.S. Food and Drug Administration has de facto adopted those standards for the U.S.
The European standards are that at least 95 percent of our blood glucose test results have to fall within plus or minus 15 mg/dl of the true result when the level is below 75 mg/dl. The standard allow a little more leeway at higher levels. Our test results have to fall within plus or minus 20 percent when the level is above 75 mg/dl. That’s simply because test results at lower levels are critical — particularly in terms of insulin dose — so these standards make sense.
The good news is that blood glucose systems from three of the four major meter manufacturers fulfilled the European requirements. Five meters from the big four fulfilled the requirements 100 percent. These are Roche’s Accu-Chek Aviva and Accu-Chek Active, Abbott’s FreeStyle Freedom and FreeStyle Lite, and LifeScan’s One Touch Ultra2. Also scoring 100 percent were two meters from a smaller company, Bionime.
In total, 16 of the 27 systems in the study fulfilled Europe’s minimum accuracy requirements. That means, of course, that more than 40 percent of them simply aren’t good enough. Quite a few of these meters are, however, not even sold in the U.S.
We knew, of course, that our meters in general aren’t good enough. And now we know which ones that we can tend to trust.
Anyway, I do encourage you to read the system accuracy evaluation study. At a minimum, please note the tables on “BG Monitoring System Accuracy Results” and “Clarke Error Grid Analysis.” Then, you may want to get a meter to replace the old one that you have been using.
This article is based on an earlier version of my article published by HealthCentral.
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