In this study, conducted by an independent research center without support from any meter manufacturer, we selected meters that are commonly used in the diabetes patient population. In this study we found that 17 commercially available glucose meters from 9 manufacturers had widely varying accuracy across a wide range of reference PG values and hemoglobin values. Statistical analysis was performed in Stata version 13.1 (StataCorp LP, College Station, TX, USA). The relationship between FDA approval date and MARD was analyzed using linear regression analysis. To assess the significance of differences in the accuracy of each meter in low versus normal hemoglobin ranges Student’s t-test was used. Relative difference (RD = / reference PG) plots were constructed with the YSI results converted to PG on the x -axis and relative difference of the meter versus the YSI on the y -axis. The Bonferroni correction was used to correct for multiple comparisons adjusted P values <. To compare the MARDs of different meters ANOVA (analysis of variance) was performed. To include these results in the numerical analyses, the results were censored by setting them to 1 mg/dl lower than the lowest value in the meter’s reported glucose concentration range (eg, 19 mg/dl for a meter with a lower limit of 20 mg/dl) or 1 mg/dl higher than the upper limit (eg, 445 for a meter with an upper limit of 444 mg/dl), respectively.Īlthough our testing method was not the one specified by the standard, we determined whether each meter met numerical criteria for accuracy described in International Organization for Standardization (ISO) 15197: 2003 (>95% within 15 mg/dl of reference 95% within 15 mg/dl of reference <100 mg/dl or within 15% of reference ≥100 mg/dl). Some measurements with the point-of-care glucose meters did not produce a numerical reading rather, they displayed a “low” or “high” message. For the purposes of converting YSI whole blood glucose measurements to PG measurements we used the hemoglobin value equal to the midpoint of each hemoglobin bin. We calculated the mean absolute relative difference (MARD = mean (|reference value – meter value|) / (reference value) × 100) versus the PG measurement derived from the YSI as the primary outcome measure. We specifically aimed to choose a meter for calibration of the continuous glucose monitor component of a bionic pancreas system for automated glucose management. The purpose of this study was to evaluate the comparative accuracy of 17 commercially available glucose meters across a wide range of reference plasma glucose (PG) values and hemoglobins (Hb). 7 The accuracy of results, the ease of technique and maintenance, and the price of both the meter and the strips are factors that are considered when choosing a glucose meter. The increase in the global prevalence of diabetes, 6 the importance of the accuracy of self monitoring glucose systems, and price pressures, have led the medical device manufacturers to develop more brands and types of glucose meters. In this setting, the impact of 1 inaccurate measurement can be magnified. 3 - 5 The safety and effectiveness of continuous glucose monitors, and automated glucose management systems that utilize them as component parts, are also critically dependent on accurate BG measurements for calibrations. 1, 2 Self monitoring of blood glucose plays an important role in the safety and efficacy of current therapy for diabetes mellitus because most dosing decisions are based on blood glucose value obtained by measuring a fingerstick capillary blood specimen on a home glucose meter. Tight glycemic control with intensive insulin therapy reduces the risk of diabetic complications.
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