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Accuracy of Home Glucose Meters Questioned, FDA Seeking New Standards

Jul 20, 2009 | Parker Waichman LLP

U.S. health regulators are considering tougher standards for the home glucose monitors that millions of diabetics rely on.  The Food & Drug Administration's (FDA) decision to reconsider the standards was  prompted by a request from a prominent doctors' group.

Home glucose monitors are used by diabetics, as well as people with hypoglycemia to keep tabs on the level of glucose in the blood.  According to a report in The New York Times, the use of home glucose meters is on the rise, even in hospitals.  Current international standards for the devices - which the FDA follows - allow them to be inaccurate by as much as 20 percent, the Times said. This can lead to serious health problems, including seizure and coma.

According to The New York Times, a government study comparing tests from five different popular home glucose monitors found results varied by as much as 32 percent.  What's more, the accuracy of the devices can be affected if people are taking drugs like Tylenol, the Times said.

In a May letter to the FDA, the American Association of Clinical Endocrinologists wrote that home glucose monitor technology is not up to par.  One concern is that  hospitals are switching to home meters in an effort to cut cost, UPI said.  A former president of the group told The New York Times that no one knows how many hospital deaths may be related to the accuracy of home glucose meters, but said such deaths probably are not rare.

"Because of the highly variable quality of the meters and the glucose testing strips in widespread use, the safety of our patients who depend upon those meters is threatened," the Associations' letter said.

In a letter to the Association, the FDA  acknowledged that it receives reports of several deaths and thousands of device-related failures associated with home glucose monitors every year.   The agency said it had contacted the International Standards Organization, which sets the parameters for home glucose monitors, asking that the accuracy standards for the devices be revised.

According to UPI, the FDA may set its own standards if the international group does not.  However, according to The New York Times, change would come more quickly if the international group changed the standards.


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