Technical accuracy of ten self-monitoring blood glucose devices commonly used in Dhaka City of Bangladesh

Due to inadequate regulatory mechanisms, the accuracy of the self-monitoring blood glucose (SMBG) devices is not ensured leading to potentially serious clinical consequences in Bangladesh. The present study was undertaken to evaluate the technical accuracy of ten most commonly used SMBG devices marketed in Dhaka City of Bangladesh. Top ten SMBG devices sold in Dhaka City were studied on a group of 100 type 2 diabetes mellitus subjects. Blood glucose values estimated (at fasting and 2 h after breakfast) by SMBG devices, using a blinding technique, were compared with the corresponding laboratory values by enzymatic method using the Dimension RXLMax automated chemistry analyzer. Hematocrit was measured using the Sysmex XT 2000 hematology autoanalyzer. The mean absolute relative error (MARE, %) was used as an indicator of accuracy and precision together. A highly significant correlation was observed between the device and laboratory values. However, none of the devices showed an acceptable accuracy at 5-10% deviation from the corresponding laboratory values either at fasting or postprandial states. On pooling together data from two prandial states, even at 15% deviation limits, 70% of the devices failed to show accurate results. On calculation of MARE, 60% devices were found to be beyond 15% error limit at 95% accuracy level. Corresponding analysis with 90% accuracy level showed 30% beyond the limit. Blood glucose results from around 30% of the top ten SMBG devices sold in Dhaka City do not have even minimum level of technical accuracy, and many others are not optimum in their accuracy levels.