BACKGROUND
Maintaining normal blood glucose levels in diabetes therapy is fundamentally linked to precise and accurate blood glucose measurements. In the light of interfering quantities like various substances or hematocrit, these aspects are of utmost clinical importance within a standardized validation of blood glucose monitors for personal use as well as a continuous quality assessment.
OBJECTIVE
Continuous and independent quality assurance of aspects affecting a blood glucose monitoring system’s performance.
METHODS
The influence of the hematocrit on the performance of three blood glucose monitors was assessed in accordance with ISO 15197 and sponsor’s requirements.
RESULTS
Only one device showed acceptable deviations of ≤ 10 mg/dL / 10 % to the reference device across the entire range. The other devices showed minor to clinically relevant interferences, particularly in response to higher hematocrit values.
CONCLUSIONS
Suitable BGM systems should be selected carefully by health care professionals and patients, especially with medical conditions known to interfere with blood glucose measurements.