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.
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.
Authors: David M Nathan; Patricia A Cleary; Jye-Yu C Backlund; Saul M Genuth; John M Lachin; Trevor J Orchard; Philip Raskin; Bernard Zinman Journal: N Engl J Med Date: 2005-12-22 Impact factor: 91.245
Authors: Andrew J Karter; Howard H Moffet; Jennifer Liu; Melissa M Parker; Ameena T Ahmed; Assiamira Ferrara; Joe V Selby Journal: Am J Manag Care Date: 2005-04 Impact factor: 2.229