Performance of a Modern Glucose Meter in ICU and General Hospital Inpatients: 3 Years of Real-World Paired Meter and Central Laboratory Results. Due to accuracy concerns, the Food and Drug Administration issued guidance to manufacturers that resulted in Center for Medicare and Medicaid Services stating that the use of meters in critically ill patients is “off-label” and constitutes “high complexity” testing. This is causing significant workflow problems in ICUs nationally. Real-world accuracy of modern glucose meters is at least as accurate in the ICU setting as in the non-ICU setting at our institution.

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