It is essential that people with diabetes have accurate tools with which they can effectively manage their disease on a day-to-day basis. And, despite all the recent technological and scientific advances in diabetes management, it appears that home blood glucose monitors—one of the most commonly used and critical tools for the management of glucose levels—are not keeping pace with the times.
In a July 2009 New York Times article, Gardiner Harris wrote that the Food and Drug Administration (FDA) is considering tightening its accuracy standards for home blood glucose monitors (BGMs). The article highlights the fact that the FDA has long followed international standards set by the International Organization for Standardization (ISO) which allow for BGMs to be manufactured with an error rate of up to 20%. While an error rate of 20% may have seemed acceptable or reasonable 10 years ago, given our present-day technology and our current understanding of the clear health benefits of tight control of glucose levels, it is simply indefensible.
To understand why this error rate is unacceptable, it is helpful to consider what a 20% error rate for a BGM actually means for an individual with diabetes. Let’s take the example of an individual who checks her glucose level and gets a reading of 156 when, in fact, her blood glucose is only 130. With a reading of 156, she might administer a correction dose of insulin to lower her glucose to a level within her target range. However, had the BGM accurately displayed her glucose level as 130, she would not have taken any insulin. This unnecessary dose of insulin could then cause her glucose levels to go too low — meaning below the low end of her target range — and cause her to suffer from hypoglycemia. Alternatively, if her blood glucose level was actually 160 but the BGM gave a reading of 128, she might not administer any insulin — because she might falsely believe that her glucose level is within her target range. Failing to administer insulin when it is needed could lead her to becoming hyperglycemic which, over time, can cause serious health complications.
As it turns out, in response to concerns from the American Association of Clinical Endocrinologists regarding BGMs’ accuracy, in June 2009, the FDA pressed the ISO to tighten its standards. In addition, the FDA has indicated that if the ISO does not act, the FDA will take the initiative itself by requiring higher performance standards for BGMs sold in the United States. However, as of September 2009, the FDA has yet to do so; rather, it appears that the FDA is still merely commenting on its plans to make changes in some way or another.
It is interesting to consider why there have not been any major improvements in the accuracy of BGMs in the past decade. BGM manufacturers have improved the technology, aesthetics, and convenience of BGMs since their introduction in the 1970s, but manufacturers have not improved the accuracy of glucose level readings — arguably the single most important feature of a BGM. As FDA Commissioner Margaret Hamburg has indicated, this is the result of manufacturers’ contentment with meeting the international standard set by the ISO. But this response begs the question: Why have market forces led BGM manufacturers to improve certain aspects of their products, but not accuracy? After all, most people with diabetes purchase and use BGMs with the goal of closely managing and monitoring their glucose levels, which in turn enables them to minimize the risks of long-term, diabetes-related complications. Perhaps BGM manufacturers have taken advantage of the fact that individuals easily notice the aesthetic difference between certain BGMs, but that most BGM users likely were never (or still aren’t) aware of the 20% error rate allowed by the FDA?
Whatever the reason for the market’s failure to promote the development of more accurate BGMs, the solution is clear. Whether by pressuring the ISO or creating its own higher standards for domestic BGM approval, the FDA should act quickly and decisively to put an end to the current tolerance of a 20% error rate for BGMs.
Ed Kraus is an Associate Clinical Professor at Chicago-Kent College of Law. Professor Kraus focuses part of his practice on representing and advocating for individuals with diabetes in education, employment and insurance matters.