Accuracy of home blood glucose meters during hypoglycemia

OBJECTIVE: To evaluate the accuracy of home blood glucose meters during hypoglycemia. METHODS: Six blood glucose meters-One Touch II (LifeScan, Milpitas, CA), Companion II (Medisense, Cambridge, U.K.), Reflolux (Boehringer Mannheim, Mannheim, Germany), Accutrend (Boehringer Mannheim), Elite (Bayer, Munich, Germany), and HemoCue (HemoCue, Angelholm, Sweden)-were compared with a reference method (Beckman Glucose Analyzer 2). Glucose concentrations from arterialized venous blood samples were measured using all glucose meters (whole blood) and the reference method (plasma) during hypoglycemic-hyperinsulinemic clamps in 15 subjects. RESULTS: In total, 663 blood glucose monitor readings and 119 reference values ranging from 2.28 to 3.89 mmol/l were analyzed. The correlation coefficients and the percentage of measurements within 20% and outside 40% of the reference values for each glucose meter were as follows: One Touch II: 0.91, 99.2% and 0%; Companion II: 0.81, 88.2% and 2.5%; Reflolux: 0.78, 85.0% and 0.9%; Accutrend: 0.88, 46.0% and 6.6%; Elite: 0.78, 75.6% and 4.2%; and HemoCue: 0.93, 96.6% and 0% (P < 0.001). CONCLUSIONS: There were substantial differences between the blood glucose meters during hypoglycemia, and none of the devices met the latest criteria recommended by the American Diabetes Association.