Background: Self-monitoring of blood glucose levels has become an important
instrument for the management of patients with diabetes mellitus, Both pat
ients and physicians expect that the monitors will provide reliable results
. Numerous environmental, physiologic, and operational factors can affect s
ystem performance, yielding results that are inaccurate or unpredictable.
Methods: This study examined the effect of one factor-high altitude-on the
performance of seven blood glucose monitoring systems. The following monito
rs were compared: two One Touch II; two One Touch Basic; two Reflolux II (A
ccu-Chec in the USA); two Glucometer 3; one Glucometer 2, and one Accutrend
Alpha, Double blood glucose level values were compared with a controlled r
eference laboratory test value, which was unknown to the investigator until
the end of the study because the study was double blind. Blood glucose val
ues were obtained using each of the monitors in 200 patients; 150 with diab
etes mellitus, and 50 healthy subjects.
Results: The One Touch monitors were the only monitors that reported adjust
ed straight lines (Y = a+bX) that were very similar for all three technique
s. In addition, these adjusted straight lines are those closest to the idea
l line, Y = X. These same monitors were the only ones that did not reject t
he null hypothesis Ho: a = 0. The relative deviation index at the 20 % leve
l was less than 3.5 % for the One Touch II and One Touch Basic monitors; fo
r the rest of the monitors, the index was over 14 %, The clinically accepte
d EGA region was similar for all study monitors.
Conclusions: In conclusion, the One Touch II and One Touch Basic Monitors s
howed greater accuracy in comparison to the other devices. The evaluation o
f the clinically acceptable region shows practical reliability for all of t
he monitors used.