Performance of Blood Glucose Meters in the Low-Glucose Range: Current Evaluations Indicate That it is not Sufficient From a Clinical Point of View.

Abstract

System accuracy requirements for blood glucose (BG) meters (BGMs) are defined in standards (1) or guidance documents (2). In 2013, International Organization for Standardization (ISO) 15197:2013 stated that BGMs are acceptably accurate if ≥95% of their measurement results are found within ±15 mg/dL (0.83 mmol/L) or ±15% (whichever is larger) of reference results (1). The 2014 U.S. Food and Drug Administration (FDA) draft guidance for over-the-counter BGMs requires ≥95% of results within ±15% and ≥99% of results within ±20% across the whole glycemic range (2). Thus, if a patient’s BG true concentration is 60 mg/dL (3.33 mmol/L), acceptably accurate results range from 45 to 75 mg/dL (2.50 to 4.16 mmol/L) according to the ISO limits and from 51 to 69 mg/dL (2.83 to 3.83 mmol/L) according to the FDA criteria. Two questions arise: 1. Do current BGMs fulfill these criteria? 2. If a BGM …