Evolution of analytical performance in portable glucose meters in the last decade.
OBJECTIVE
To assess and compare the technical accuracy of portable glucose meters during the last decade.


METHODS
One-thousand preprandial (pre) and postprandial (post) capillary whole-blood glucose values measured with meters owned mainly by diabetic patients were compared with a single laboratory method yearly from 1989 to 1999. A total of 21,950 capillary measurements and their corresponding laboratory reference values were analyzed at our clinic.


RESULTS
The lowest mean absolute difference was found in 1989 (pre: 2 +/- 22 mg/dl, post: 9 +/- 31 mg/dl) (mean +/- SD). The highest mean absolute difference was observed in 1993 (pre: 31 +/- 33 mg/dl) and 1996 (post: 50 +/- 35 mg/dl). The highest mean relative deviation was observed in 1990 (pre: 16.4%) and 1996 (post: 20.6%). The highest percentage of readings that were within a 5% deviation limit were observed in 1998 (pre: 44.5%) and in 1997 (post: 36.7%). Based on blood glucose levels within +/-5 and +/-10% of laboratory values, the technical accuracy of meters was similar for 1989 and 1999 (P = 0.27 and 0.52, respectively). The percentage of pre values in zone A of Clarke's error grid analysis was >90% in 1989, 1997, 1998, and 1999.


CONCLUSIONS
The analytical performance of glucose meters decreased between 1990 and 1996 but was restored between 1997 and 1999. Nevertheless, our data suggest that the technical accuracy of glucose meters has not significantly improved during the last decade. Complementary studies taking into account the preanalytical improvements of the recent meters, as well as their calibration method, appear necessary.
Böhme
Philip
P
Service de Diabétologie, Maladies Métaboliques & Maladies de la Nutrition, Hôpital Jeanne d'Arc, CHU Nancy, France. p.bohme@chu-nancy.fr
Floriot
Michele
M
Sirveaux
Marie-Aude
MA
Durain
Danielle
D
Ziegler
Olivier
O
Drouin
Pierre
P
Guerci
Bruno
B
D001774:Blood Chemical Analysis / Q000379:methods* / Q000639:trends; D001786:Blood Glucose / Q000032:analysis*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000097:blood; D005215:Fasting; D006801:Humans; D019518:Postprandial Period; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013997:Time Factors
D001786:Blood Glucose