Report: Standards for glucose monitors may change

7/21/2009

NEW YORK Federal officials may soon require improvements for the glucose monitors used by more than 11 million diabetics in the United States, the New York Times has reported.

Home glucose monitors, which can have an error rate of as much as 20%, can leave patients vulnerable to more dire consequences, including coma and death. Because of this, the Food and Drug Administration is seeking out The International Organization for Standardization to revise the international standards for such glucose monitoring systems.

In May, the American Association of Clinical Endocrinologists urged that revisions be made in a letter to said officials. “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,” they wrote.

An organization representing the monitor manufacturers, however, believes that the current standards are working. Meanwhile, a study by government researchers found that when comparing tests from five different popular monitors, results varied by as much as 32%, the New York Times reported.

According to the New York Times, diabetes has been diagnosed in 18 million people in the United States, and another 6 million are estimated to have the disease without knowing it. It is the seventh leading cause of death and costs the United States an estimated $174 billion a year, with the federal Medicare program spending $1 billion on diabetes test strips alone.

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