Accuracy Evaluation of CONTOUR?PLUS Compared With Four Blood Glucose Monitoring Systems

摘要

Introduction: The aim of this study was to compare the accuracy of 5 blood glucose monitoring systems (BGMSs; CONTOUR?PLUS [CP], Accu-Chek? Active [ACA], Accu-Chek? Performa [ACP], FreeStyle Freedom? [FF], OneTouch? SelectSimple? [OTSS]). Methods: Study staff tested fingerstick samples from 106 subjects aged ≥18 years using the 5 BGMSs. Some samples were modified to achieve blood glucose concentrations throughout the measuring range. The primary endpoint was comparison of the mean absolute relative difference (MARD) from the reference value (Yellow Springs Instruments [YSI]) across the overall tested glucose range. Other endpoints were MARD in the low (≤80 mg/dL [≤4.4 mmol/L]), middle (81–180 mg/dL [4.5–10.0 mmol/L]), and high (>180 mg/dL [>10.0 mmol/L]) glucose ranges, and MARD for unmodified samples in the overall glucose range. Results: CONTOUR?PLUS had a statistically significantly lower MARD than all BGMSs across the overall tested range (27–460 mg/dL [1.5–25.5 mmol/L]) and in the high glucose range. In the low glucose range, CP had a lower MARD than all BGMSs, which was statistically significant except for ACP. For unmodified samples across the overall tested range, CP had a lower MARD than all BGMSs and was statistically significantly lower except for ACA. Conclusions: CONTOUR?PLUS had the lowest mean difference from the reference values (by MARD) when compared with other BGMSs across multiple glucose ranges with modified and unmodified samples. Funding: Bayer HealthCare LLC, Diabetes Care. Trial registration number: ClinicalTrials.gov Identifier NCT01714232.