New, small, fast acting blood glucose meters--an analytical laboratory evaluation.

Background: Patients and medical personnel are eager to use blood glucose meters that are easy to handle and fast acting. We questioned whether accuracy and precision of these new, small and light weight devices would meet analytical laboratory standards and tested four meters with the above mentioned conditions.

Methods: Approximately 300 capillary blood samples were collected and tested using two devices of each brand and two different types of glucose test strips. Blood from the same samples was used for comparison. Results were evaluated using maximum deviation of 5% and 10% from the comparative method, the error grid analysis, the overall deviation of the devices, the linear regression analysis as well as the CVs for measurement in series.

Results: Of all 1196 measurements a deviation of less than 5% resp. 10% from the reference method was found for the FreeStyle (FS) meter in 69.5% and 96%, the Glucocard X Meter (GX) in 44% and 75%, the One Touch Ultra (OT) in 29% and 60%, the Wellion True Track (WT) in 28.5% and 58%. The error grid analysis gave 99.7% for FS, 99% for GX, 98% for OT and 97% for WT in zone A. The remainder of the values lay within zone B. Linear regression analysis resembled these results. CVs for measurement in series showed higher deviations for OT and WT compared to FS and GX.

Conclusions: The four new, small and fast acting glucose meters fulfil clinically relevant analytical laboratory requirements making them appropriate for use by medical personnel. However, with regard to the tight and restrictive limits of the ADA recommendations, the devices are still in need of improvement. This should be taken into account when the devices are used by primarily inexperienced persons and is relevant for further industrial development of such devices.