![]() ![]() Inclusion criteria were review articles of BG accuracy, original articles that reported the performance of blood glucose meters in laboratory settings, original articles that reported the performance of blood glucose meters in clinical settings, and simulation modeling of BG. Titles and abstracts of identified citations were screened, and articles were identified as eligible based on the following criteria. Also discussed are differences between what level of accuracy is needed for appropriate analytical performance and appropriate clinical performance and why different settings might require different levels of accuracy. ![]() This article reports on the review of the published literature to provide information on current blood glucose monitor performance. ![]() The authors undertook an analysis of the literature to understand the performance of blood glucose monitors in the real world. There is currently a lack of consensus on the performance standards for blood glucose monitors and whether target values of an expanded ISO 15197 standard would be appropriate. To our knowledge, an internationally accepted reference method for the determination of whole BG concentration does not exist. 1 The term “accuracy” as applied to analytical performance is defined by the International Organization for Standardization (ISO) as “the difference between the expectation of measurement results and the true value of the measured quantity.” In essence, it is a measure of the difference between obtained results (by the blood glucose monitor) and the true value (determined by an accepted reference method). Considerations for improving the accuracy of glucose monitoring systems emphasize technical improvements and improved patient education to decrease user error. The overall performance of self-monitoring of blood glucose (SMBG) systems is a combination of the analytical performance of the instrument, quality of the test strips, and proficiency of the user. When performed and utilized properly, monitoring of blood glucose (BG) permits people with diabetes to determine their BG level and use the information as part of their treatment program. ![]()
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