Accuracy of a Simplified Glucose Measurement Device--The HemoCue Glucose 201RT

Abstract

Background: Easily available, accurate glucose recordings are important when screening for and managing people with diabetes. The photometric HemoCue(®) (Ängelholm, Sweden) Glucose 201+ system, which delivers lab-comparable glucose recordings, has the drawback that its microcuvettes must be delivered and stored at 4-8°C. A newly developed system, HemoCue Glucose 201RT, has microcuvettes that can be stored at room temperature.

Subjects and methods: Participants (n=444; 18-80 years old) in the EUROASPIRE IV survey, all with coronary artery disease, some with known diabetes, were investigated. Plasma glucose recordings, fasting in all participants and postprandial in the majority, were simultaneously recorded with both pieces of equipment. Congruence was expressed as median absolute difference and median absolute relative difference between the two sets of equipment and also compared according to the International Organization for Standardization (ISO) 15197:2013 criteria. Clinical accuracy was calculated with Clarke error grid analysis and cross-tabulated while considering different glucose categories (normal, impaired glucose tolerance, and diabetes).

Results: The median absolute difference between the two devices was +0.1 mmol/L, and the median absolute relative difference was +5.4%. This also corresponded with the ISO criteria. In the Clarke error grid, 99.8% ended up in Zones A and B, and 90% of the glucose values in the cross-table allocated the participant to the same glucose category.

Conclusions: The HemoCue Glucose 201RT system is accurate, with small nonsystematic deviations, when compared with the commonly used HemoCue Glucose 201+. It is predicted that the HemoCue Glucose 201RT, which is more user friendly, will be a preferred alternative to the HemoCue Glucose 201+.