Self-monitoring of blood glucose levels requires intensive training for use of meters to obtain reliable and clinically relevant measurements.
BACKGROUND
Anecdotal reports from pediatric sites have indicated that some blood glucose meters may display wrong and misleading numbers rather than error indications, when operated in deviation from the instructions for use (IFU), eg by manipulating the strip during the count-down phase.


METHODS
This study was performed with 60 patients with diabetes (32 female, 28 male, 21 type 1, 39 type 2, age (mean+/-SD): 56+/-11 years) who measured their blood glucose levels twice with five different blood glucose meters (Precision(R) Xceed [Abbott Medisense], Freestyle Mini [Abbott Medisense], Accu-Chek Comfort [Roche Diagnostics], Accu-Chek Aviva [Roche Diagnostics], and Ascensia Contour [Bayer Vital]). The first measurement was performed in accordance with the IFU, and the second by manipulating the test strip using a standardised inflexion/release procedure during the count-down phase. A standard glucose oxidase method (SuperGL) served as laboratory reference.


RESULTS
All meters worked in full compliance with current accuracy standards when operated according to the IFU. When manipulating the test strip, the results varied considerably: While changes in reliability were acceptable for two devices (Precision Xceed, Freestyle Mini), the other devices produced an unacceptable number of errors and a series of entirely wrong values without error indication.


CONCLUSIONS
The use of all devices is recommended when used according to the IFU. The use under the artificially induced impaired testing conditions is a major concern. This study underlines the importance of appropriate patient training regarding adherence to the IFU of glucose meters.
Mohr
Thomas A
TA
Institute of Clinical Research and Development, Mainz, Germany. thomass@ikfe.de
Pfützner
Andreas
A
Forst
Senait
S
Forst
Thomas
T
Schöndorf
Thomas
T