Not All Blood Glucose Monitors Are Created Equal
Nearly 24 million men, women, and children in the United States alone have diabetes. For all those people, testing their blood with a blood glucose monitor is a routine that simply cannot be avoided. Of the 24 million people with diabetes in the United States, approximately one-third of them rely on medicating with insulin, depending on the reading they get from testing with a blood glucose monitor. Therefore, accuracy from these devices is of the utmost importance to the people whose very lives depend on them.
If a blood glucose monitor provides a false reading, it puts a patient at risk of dosing with too much or too little insulin. If too much insulin is given, it can bring blood glucose levels down to dangerously low levels, putting the patient at risk of severe hypoglycemia and possible hospitalization.
The Food and Drug Administration (FDA) requires that glucose monitors have a 95 percent accuracy. But, recently researchers at the Diabetes Technology Society spoke at a meeting in Arlington, VA, where they claim that many glucose monitors on the market today are falling short of this accuracy requirement.
There is some debate over what a normal range of a blood glucose reading is. But, most experts define normal as between 80 and 120 mgdl. A false or inaccurate reading with some of these monitors has been shown to be between 15-20 mgdl at times. Therefore, this measurable difference in a person’s blood glucose is dramatic enough to cause a hypoglycemic event or worse. So it stands to reason that this realization of inaccuracy among some monitors should not be taken lightly.
Unfortunately, the FDA maintains that their hands are tied to a certain extent. Katherine Serrano, diabetes branch chief in the FDA’s division of chemistry and toxicology devices, said the federal government is aware of accuracy problems with certain monitors. However, the FDA is limited in its response because some manufacturers are in Asia, and the agency must rely on the manufacturers’ own studies related to accuracy claims.
The moral of the story is this: If you are type 1 or type 2 diabetic, and test your blood with a blood glucose monitor, think carefully before purchasing. Don’t necessarily buy the cheapest one out there, and perhaps it would be beneficial to do a bit of research before making a purchase.
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