Accuracy of Newer-Generation Home Blood Glucose Meters in a Diabetes Research in Children Network (DirecNet) Inpatient Exercise Study

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Abstract
Background: The objective of this study was to assess how the accuracy of the FreeStyle® Flash™ (Abbott Diabetes Care, Alameda, CA) meter compares with that of the One Touch® Ultra ® (Lifescan, Milpitas, CA) home glucose meter (HGM). Research Design and Methods: Fifty children with type 1 diabetes (T1D), 10–17 years old, were admitted for two separate 24-h periods to assess the effect of exercise on subsequent nocturnal hypoglycemia. Resulting data were used in a preplanned analysis of the accuracy of the Ultra and FreeStyle HGMs. Glucose levels were measured throughout the day and night and every 15–20 min during a standardized exercise protocol. Reference samples were assayed in a central laboratory using a hexokinase enzymatic method. These reference glucose measurements were paired with HGM values from venous blood obtained within ± 5 min. Results: The median relative absolute difference was 5% for both the Ultra and FreeStyle HGMs, and the percentages of pairs meeting the International Organisation for Standardization criteria were 99% and 98%, respectively. The FreeStyle tended to read slightly higher than the reference method (median difference = +3 mg/dL; P < 0.001), and there was trend in this direction for the Ultra (median difference = +2 mg/dL, P = 0.15). Sensitivities for detection of hypoglycemia (reference ≤60 and HGM ≤70 mg/dL) were 96% and 100% for the Ultra and FreeStyle, respectively, and corresponding false-positive rates were both 5%. Conclusions: In a controlled clinical setting using venous blood samples, both the Ultra and FreeStyle meters demonstrated a high degree of accuracy compared with the laboratory reference over a broad range of glucose concentrations in children with T1D.