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Accuracy Evaluation of a Blood Glucose Monitoring System in Chinese Individuals

For people with diabetes mellitus, self-measured blood glucose (SMBG) using a portable blood glucose (BG) meter plays a key role in controlling BG level and is an important component of diabetes management. In contrast with SMBG systems based on traditional static electrochemical technology, the BGStar® (AgaMatrix, Salem, New Hampshire, USA) SMBG meter uses dynamic electrochemistry and the glucose oxidase measurement principle, and has been shown to correct for hematocrit interference on BG measurement within the system’s operating limits. This SMBG meter was not approved in China when the present study was initiated, and we evaluated its clinical accuracy and safety for SMBG measurement in diabetic and nondiabetic Chinese people. In this study, accuracy assessments were performed in accordance with the International Organization for Standardization (ISO) 15197:2003 standard (the current version at the time of study initiation), and the China Food and Drug Administration’s (CFDA) requirements. Reference BG measurements were acquired from 2 systems; the manufacturer’s recommended reference, the YSI 2300 STAT Plus Glucose and Lactate Analyzer (YSI Life Sciences, USA), and a CFDA-approved system, the StatStrip® Glucose Connectivity Meter (Nova Biomedical, USA). Two BG measurements were made using each reference method before and after duplicate measurements using the SMBG meter and system accuracy was assessed as described in ISO 15197:2003. A post hoc evaluation using ISO 15197:2013 was also performed. Of 412 individual SMBG meter results obtained from 206 evaluable participants, >95% deviated within ±15 mg/dL for BG values <75 mg/dL and ±20% for BG values ≥75 mg/dL in comparison with the mean YSI (99.5%) and StatStrip (99.0%) measurements, and therefore exceeded the minimum ISO 15197:2003 accuracy requirement (Table 1). Passing and Bablok regression analysis correlation coefficients were 0.99 and 0.98 against YSI and StatStrip, respectively. Consensus Error Grid analysis revealed that 100% of data points fell in zones A and B. Using ISO 15197:2013; >95% of individual SMBG meter values deviated within ±15 mg/dL for BG <100 mg/dL or ±15% for BG ≥100 mg/dL in comparison with the mean YSI (98.5%) and StatStrip (95.6%) measurements (Table 1). The SMBG meter was safely operated; no device-related AEs were reported during the study. In addition, no product technical complaints were reported during the study. Although our study protocol was designed with reference to ISO 15197:2003, a post hoc analysis showed that >95% of SMBG meter measurements agreed with the mean YSI reference measurements within the more stringent tolerances set out in the current ISO 15197:2013 standard. Unfortunately, further changes in ISO 15197:2013 such as acquiring data from 3 different reagent system lots (3 test strip lots) and testing by the intended users were not included in the present study design. Despite these limitations, the strengths of our study include the careful study design and conduct, and the use of 2 reference methods to fulfill and overcome specific regulatory requirements. In summary, this study confirms that the SMBG meter evaluated exceeds the minimum accuracy standards for BG 651882 DSTXXX10.1177/1932296816651882Journal of Diabetes Science and TechnologyGuo et al letter2016