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

• Published in: Diabetes care Vol. 26; no. 4; pp. 1170 - 1175
• Main Authors: BÖHME, Philip, FLORIOT, Michele, SIRVEAUX, Marie-Aude, DURAIN, Danielle, ZIEGLER, Olivier, DROUIN, Pierre, GUERCI, Bruno
• Format: Journal Article
• Language: English
• Published: Alexandria, VA American Diabetes Association 01.04.2003
• Subjects: Accuracy; Biological and medical sciences; Blood Chemical Analysis - methods; Blood Chemical Analysis - trends; Blood Glucose - analysis; Diabetes; Diabetes Mellitus, Type 1 - blood; Diabetes Mellitus, Type 2 - blood; Diabetes. Impaired glucose tolerance; Endocrine pancreas. Apud cells (diseases); Endocrinopathies; Fasting; Glucose; Home medical tests; Humans; Management. Various non-drug treatments. Langerhans islet grafts; Medical sciences; Postprandial Period; Reproducibility of Results; Sensitivity and Specificity; Time Factors; Endocrinopathy; Performance evaluation; Human; Measurement; Immunopathology; Autoimmune disease; Non insulin dependent diabetes; Biological monitoring; Measurement technique; Laboratory investigations; Insulin dependent diabetes; Evolution; Portable equipment; Comparative study; Glycemia; Capillary blood
• ISSN: 0149-5992; 1935-5548
• DOI: 10.2337/diacare.26.4.1170

Evolution of Analytical Performance in Portable Glucose Meters in the Last Decade Philip Böhme , MD , Michele Floriot , MD , Marie-Aude Sirveaux , MD , Danielle Durain , RN , Olivier Ziegler , MD, PHD , Pierre Drouin , MD and Bruno Guerci , MD, PHD From the Service de Diabétologie, Maladies Métaboliques & Maladies de la Nutrition, Hôpital Jeanne d’Arc, CHU Nancy, France 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 ± 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. EGA, error grid analysis HB, home blood glucose meter RM, reference method Footnotes Address correspondence and reprint requests to Dr. Philip Böhme, Service de Diabétologie, Maladies Métaboliques & Maladies de la Nutrition, Hôpital Jeanne d’Arc, Centre Hospitalo-Universitaire de Nancy, BP 303, 54201 Toul cedex, France. E-mail: p.bohme{at}chu-nancy.fr . Received for publication 22 August 2002 and accepted in revised form 15 January 2003. A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances. DIABETES CARE