In Clinical Trial 2, these ranges were: CONTOUR(®)NEXT BGMS (CN), -0.7 to 1.7 Accu-Chek(®) Aviva Nano BGMS (ACAN), -1.3 to 1.8 FreeStyle Lite(®) BGMS (FSL), -5.1 to 0.2 OTU2, -1.9 to 1.2 OneTouch(®) Verio(®) Pro BGMS (OTVP), -1.0 to 1.9 and TT, -5.1 to 1.7. In Clinical Trial 1, 95% dose error ranges (in units of insulin) were: CONTOUR(®)NEXT EZ BGMS (EZ), -0.9 to 0.5 Accu-Chek(®) Aviva BGMS (ACA), -0.5 to 1.8 FreeStyle Freedom Lite(®) BGMS (FFL), -3.2 to -0.3 OneTouch(®) Ultra(®)2 BGMS (OTU2), -4.1 to 0.3 and Truetrack(®) BGMS (TT), -3.9 to 2.2. Dosing error was the difference between doses calculated using the BGMS and YSI results. In post hoc analyses, hypothetical insulin doses were calculated using these blood glucose measurements dosing errors were compared for each trial.įor each blood glucose measurement, premeal bolus insulin dosing was determined for a hypothetical person, assuming a 60-g carbohydrate meal and 100-mg/dL target blood glucose level (adjusting 1/25 insulin sensitivity and 1/15 insulin:carbohydrate ratio inputs to account for BGMS measurement error). In 2 previous clinical trials, fingertip capillary blood samples were evaluated using prespecified blood glucose monitoring systems (BGMSs) and a reference YSI glucose analyzer. The tight clustering of data points at the center of the CN Radar Plot illustrates the analytical performance of CN compared with 5 other BGMSs. Radar Plots provide a different method for visually comparing the analytical performance of multiple BGMSs. The percentage of results within the 15-15 Zone ranged from 83.6% to 99.8% for the 6 BGMSs (99.6% for CN).
Contour next vs contour next one iso#
Points within the "15-15 Zone," representing ☑5 mg/dL or ☑5% error, satisfy ISO 15197:2013 accuracy criteria. The center of the plot represents zero error (BGMS result is equivalent to reference result) as points are more distant from the center, the error increases, expressed in units of mg/dL or percentage for YSI values YSI result) or negative (BGMS result < YSI result). Here, we use Radar Plots to graphically represent the accuracy and precision results from the previous study, including whether they met ISO 15197:2013 accuracy criteria.Ī Radar Plot, a new method for capturing a distinct, single visualization of BGMS analytical performance, is a collection of concentric circles, each representing a particular magnitude of error. Previously, fingertip capillary blood glucose measurements from the CONTOUR(®)NEXT (CN) blood glucose monitoring system (BGMS) and 5 other BGMSs were evaluated in comparison with measurements from a reference YSI glucose analyzer. When compared with other BGMSs, CN demonstrated the lowest mean deviation from the reference value (by MAD and MARD) across multiple glucose ranges. In the overall glucose range (21-496 mg/dL), CN yielded the lowest MAD and MARD values, which were statistically significantly lower in comparison with the other BGMSs.
CN also had a statistically significantly lower MARD than all other BGMSs in the low glucose range. The lowest MAD in the low glucose range, from CN, was statistically significantly lower than those of the other BGMSs with the exception of the FSL. In the low glucose range (<70 mg/dL), MAD values were as follows: Accu-Chek(®) Aviva Nano (Roche Diagnostics, Indianapolis, IN), 3.34 mg/dL CN, 2.03 mg/dL FreeStyle Lite(®) (FSL Abbott Diabetes Care, Inc., Alameda, CA), 2.77 mg/dL OneTouch(®) Ultra(®) 2 (LifeScan, Inc., Milpitas, CA), 10.20 mg/dL OneTouch(®) Verio(®) Pro (LifeScan, Inc.), 4.53 mg/dL and Truetrack(®) (Nipro Diagnostics, Inc., Fort Lauderdale, FL), 11.08 mg/dL. System accuracy was assessed by mean absolute difference (MAD) and mean absolute relative difference (MARD) across several glucose ranges, with <70 mg/dL evaluated by MAD as the primary end point. Extreme glucose values were achieved by glucose modification of the blood sample. Capillary blood samples were tested on six BGMSs and a YSI glucose analyzer (YSI Life Sciences, Inc., Yellow Springs, OH) as the reference.
Subjects' glucose levels were safely lowered or raised to provide a wide range of glucose values. Subjects (n=146) were ≥ 18 years and had type 1 or type 2 diabetes. This study evaluated the accuracy of Contour(®) Next (CN Bayer HealthCare LLC, Diabetes Care, Whippany, NJ) compared with five blood glucose monitoring systems (BGMSs) across a wide range of clinically occurring blood glucose levels.
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