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Blood Glucose Meter Accuracy Unclear at Low Glycemic Range

The accuracy of blood glucose meters (BGMs) in the low glycemic range is questionable, according to an observation published letter. This prompts concerns regarding safety for measuring blood glucose and when BGMs are used in trials. Noting that the U.S. Food and Drug Administration draft guidance for over-the-counter BGMs requires ≥95 percent of results within ±15 percent and ≥99 percent of results within ±20 percent across the whole glycemic range, Lutz Heinemann, Ph.D., from Science & Co. in Düsseldorf, Germany, and colleagues examined whether current BGMs fulfill these criteria. The authors also queried the use of predefined hypoglycemia thresholds when a BGM cannot reliably differentiate between 50, 60, and 70 mg/dL. — DOI: 10.2337/dc15-08117; Diabetes Care Publish Ahead of Print, published online July 15, 2015