Validation of a new generation POCT glucose device with emphasis on aspects important for glycemic control in the hospital care.

ABSTRACT

BACKGROUND: Point-of-care (POC) glucose devices are widely used for insulin-dosage decision-making although such an application is not always permitted. In this study, we have evaluated a new generation of POC glucose device, the HemoCue(®) Glucose 201DMRT (201DMRT), for its suitability for (tight) glycemic control. MATERIALS AND METHODS: This study was performed according to the CLSI/STARD criteria. The 201DMRT was compared to the laboratory hexokinase glucose method (Siemens Dimension Vista(®)). The variation among different POC devices and cuvette lot numbers was examined. Additionally, the influence of the partial pressure of oxygen and hematocrit on glucose measurement was investigated. RESULTS: The 201DMRT showed a good agreement with the laboratory reference method. This was examined using Deming regression analysis, percentage Bland-Altman plot and a modified Clarke-error grid. The total analytical error at the clinically critical glucose concentrations of 5.6, 7.0 and 11.1 mmol/L (101, 126 and 200 mg/dL) was 6.4%, 4.3% and 3.0%, respectively. The total error among the different POC devices and among different cuvette lot numbers was <6.5%. Glucose measurements on the 201DMRT were not affected by changes in partial pressure of oxygen, whereas changes in hematocrit had influence on the results (3.4% for every 0.10 L/L change in hematocrit). CONCLUSIONS: The 201DMRT device can be used for glycemic control based on analytical results presented. However, the clinical applicability for tight glycemic control must be confirmed in a clinical study.