Evaluation of Four Blood Glucose Monitoring Systems for Self-Testing with Built-in Insulin Dose Advisor Based on ISO 15197:2013: System Accuracy and Hematocrit Influence.

Background: Self-monitoring of blood glucose (SMBG) is important in diabetes therapy; however, not all SMBG systems are sufficiently accurate. In addition, some SMBG systems are influenced by the user's hematocrit value.

Methods: System accuracy and hematocrit influence was evaluated for four SMBG systems with built-in insulin dose advisors (Accu-Chek Aviva Expert [1], FreeStyle InsuLinx [2], FreeStyle Precision Neo [3], MyStar DoseCoach [4]) based on International Organization for Standardization (ISO) 15197:2013 section 6.3 (system accuracy) and 6.4.3 (packed cell volume [hematocrit]) with three test strip lots for each system. Two different established comparison methods were used to investigate a possible impact of the comparison method on analytical performance data.

Results: Two systems (2, 4) fulfilled ISO 15197:2013 accuracy criteria when the manufacturer's comparison measurement method was applied and showed with all three tested lots 97% to 99.5% of results within ±15 mg/dL and ±15% of the comparison measurement results at blood glucose (BG) concentrations <100 and ≥100 mg/dL, respectively, and 100% of results within consensus error grid zones A and B. Regarding hematocrit influences, two systems (3, 4) showed with all three tested lots ≤10 mg/dL and ≤10% difference between the test sample and the respective control sample for BG concentrations <100 and ≥100 mg/dL, respectively, when using the manufacturer's comparison measurement method.

Conclusions: When using the manufacturer's comparison measurement method, two out of four SMBG systems fulfilled the minimum system accuracy requirements of ISO 15197:2013. In addition, varying hematocrit levels can affect measurement results with some SMBG systems with built-in insulin dose advisors.