ArticleJournal of diabetes science and technology2022
Mean Absolute Relative Difference of Blood Glucose Monitoring Systems and Relationship to ISO 15197.
Article in Journal of diabetes science and technology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed, 17 citations in OpenAlex.
- Noninvasive Continuous Glucose Monitoring With a Novel Wearable Dial Resonating Sensor: A Clinical Proof-of-Concept Study.Journal of diabetes science and technology · 2024Trial
- A feature-centric predictive and sensitivity analysis framework for bio-oil yield assessment in biomass pyrolysis.Scientific reports · 2026Article
- Nanostructured electrode materials and flexible-substrate engineering for wearable multi-analyte biosensors in diabetes monitoring and personalized care: a comprehensive review.Journal of materials science. Materials in medicine · 2026Review
- Simultaneous Use of Continuous Glucose Monitoring (CGM) Systems and the Remote Electrical Neuromodulation (REN) Wearable for Patients with Comorbid Diabetes and Migraine: An Interventional Single-Arm Compatibility Study.Journal of clinical medicine · 2026Article
- Numerical and Clinical Accuracy of the FreeStyle Libre 2 System: A Diagnostic Accuracy Study in Critically Ill Patients.Clinical medicine insights. Endocrinology and diabetes · 2026Article
- Residual Safety Margin-Based Risk Stratification for Hospital-Wide POCT Glucose Meters Anchored to ISO 15197: Moving Beyond Pass-Fail.Diagnostics (Basel, Switzerland) · 2025Article
- Clinical validation of noninvasive blood glucose measurements by midinfrared spectroscopy.Communications medicine · 2025Article
- Optimizing Perioperative Glycaemic Control with Continuous Glucose Monitoring in Pregestational Diabetes: Feasibility and Comparative Analysis of Two Systems: A Pilot Study.Journal of clinical medicine · 2025Article
- Evaluation of Asymptomatic Fasting Hypoglycemia in Outpatients Without Diabetes.Journal of the American Board of Family Medicine : JABFM · 2025Article
- Post-Market Surveillance Assessment of the Clinical Accuracy of a Blood Glucose Monitoring System with an Improved Algorithm for Enhanced Product Performance.Journal of diabetes science and technology · 2023Article
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Authors and funding
7 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe 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.
methodsResults 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.
resultsMARD 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%.
conclusionThere is a threshold MARD that may allow an estimate whether ISO 15197 requirements are fulfilled, but this statement cannot be made with certainty.
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