Mean Absolute Relative Difference of Blood Glucose Monitoring Systems and Relationship to ISO 15197. (September 2022)

• Record Type: Journal Article
• Authors: Freckmann, Guido; Mende, Jochen; Pleus, Stefan; Waldenmaier, Delia; Baumstark, Annette; Jendrike, Nina; Haug, Cornelia
• Is Part Of: Journal of diabetes science and technology. Volume 16:Number 5(2022)
• Page Start: 1089
• Page End: 1095
• Publication Date: 2022-09
• Subjects: accuracy -- ISO 15197:2013 -- mean absolute relative difference -- self-monitoring of blood glucose; Diabetes -- Periodicals; Medical technology -- Periodicals; Diabetes Mellitus -- Periodicals; 616.462005
• DOI: 10.1177/19322968211001402
• Languages: English
• ISSNs: 1932-2968

Abstract

Background: The analytical quality of a blood glucose monitoring system (BGMS) is often assessed according to the requirements described in the international standard ISO 15197. However, the mean absolute relative difference (MARD) is sometimes used as well. This analysis aims at providing empirical data from BGMS evaluation studies conducted according to ISO 15197 and at providing an estimation of how MARD and percentage of measurement results within ISO accuracy limits are related. Methods: Results of 77 system accuracy evaluations conducted according to ISO 15197 were used to calculate MARD between BGMS and a laboratory comparison method's results (glucose oxidase or hexokinase method). Additionally, bias and 95%-limits of agreement (LoA) using the Bland and Altman method were calculated. Results: MARD results ranged from 2.3% to 20.5%. The lowest MARD of a test strip lot that showed <95% of results within ISO limits was 6.1%. The distribution of MARD results shows that only 3.6% of test strip lots with a MARD equal to or below 7% showed <95% of results within ISO limits (2.2% of all test strip lots). Bias of test strip lots that showed ≥95% of results within the limits ranged from −10.3% to +7.4%. The half-width of the 95%-LoA of test strip lots that showed ≥95% of results within the limits ranged from 4.8% to 24.0%. Conclusion: There is a threshold MARD that may allow an estimate whether ISO 15197 requirements are fulfilled, but this statement cannot be made with certainty.