Evolution of Analytical Performance in Portable Glucose Meters in the Last Decade

Abstract

OBJECTIVE -To assess and compare the technical accuracy of portable glucose meters during the last decade.RESEARCH DESIGN AND 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 Ϯ 22 mg/dl, post: 9 Ϯ 31 mg/dl) (mean Ϯ SD). The highest mean absolute difference was observed in 1993 (pre: 31 Ϯ 33 mg/dl) and 1996 (post: 50 Ϯ 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 Ϯ5 and Ϯ10% of laboratory values, the technical accuracy of meters was similar for 1989 and 1999 (P ϭ 0.27 and 0.52, respectively). The percentage of pre values in zone A of Clarke's error grid analysis was Ͼ90% 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. Diabetes Care 26:1170 -1175, 2003S elf-monitoring of blood glucose is now considered to be an important tool in the management of insulintreated diabetes (1). Its importance has increased since Diabetes Control and Complications Trial results have shown that proper control of glucose levels is associated with a reduced risk of microvascular disease in type 1 diabetes (2). Portable glucose meters are widely used in type 2 diabetes, although their contribution to blood glucose improvement has not been established (3). In the last two decades, results obtained with glucose meters appear to have become more reproducible and accurate. The meters have also become smaller, faster for blood glucose analysis, and easier to use (4,5). Although there are some studies concerning user error (6,7), information relating to the evolution of analytical error appears limited (8). To determine whether the analytical accuracy has changed in relation to the global improvement of meter performances, we have prospectively compared, at our clinic and under medical control, 1,000 preprandial and postprandial capillary blood glucose measures using various portable meters on a yearly basis between 1989 and 1999 in comparison to a single reference method (RM). RESEARCH DESIGN AND METHODS -In our Department ofDiabetes, most of the diabetic patients (mainly type 1 and type 2 diabetes) benefit from an annual check-up during which each patient's device ...

Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus

“…Moreover, meters store up to several hundred results that can subsequently be downloaded for analysis. Together, these improvements have improved the performance of new meters (122,123 ). Nonetheless, meter performance in the hands of patients does not equal potential performance as judged by performance in the hands of skilled medical technologists (124 ).…”

Programme d'assurance qualité des analyseurs de glycémie capillaire au lit du patient : une revue de la littérature et une expérience de sept ans

“…Certains PAQ utilisent du plasma capillaire sur fluorure [11]. Récemment, certains auteurs [27] préconisent l'utilisation de l'iodoacétate comme antiglycolytique, car il intervient à la cinquième étape de la cascade de la glycolyse, au lieu de la huitième pour le fluorure ; mais même avec cet antiglycolytique, la décroissance du glucose plasmatique suit une pente de 9 %, pendant les deux premières heures, avant que l'effet se fasse sentir.…”

“…Ces critères sont moins drastiques dans les recommandations de l'Alfediam (Association française d'étude du diabète et des maladies métaboliques) [17] : CV maximal de 10 % quelle que soit la valeur de la glycémie ; ils sont retenus dans certaines évaluations [11,24,64].…”

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