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FDA Says Diabetes Glucose Meters Not Entirely Accurate

By Phil Galewitz

Blood glucose meters, which millions of diabetics rely upon to regulate their blood sugar, have become less costly and easier and less painful to use.

But they haven’t become more accurate, a top Food and Drug Administration official said Tuesday at a meeting of researchers analyzing studies that show wide variation in the performance of the machines used to measure blood glucose levels.

Katherine Serrano, diabetes branch chief in the FDA division of chemistry and toxicology devices, said the federal government is aware of accuracy problems with meters on the market. But she said 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. Read the full story »