ArticleJournal of diabetes science and technology2014
Analytical performance of glucose monitoring systems at different blood glucose ranges and analysis of outliers in a clinical setting.
Article in Journal of diabetes science and technology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Who cites it
11 citing papers in PubMed.
- Quality assessment of glucose measurement with regard to epidemiology and clinical management of diabetes mellitus in Germany.Frontiers in molecular biosciences · 2024Article
- Clinical Study of a High Accuracy Green Design Blood Glucose Monitor Using an Innovative Optical Transmission Absorbance System.Journal of diabetes science and technology · 2022Article
- System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015.BMJ open diabetes research & care · 2020Article
- User Performance Evaluation of Four Blood Glucose Monitoring Systems Applying ISO 15197:2013 Accuracy Criteria and Calculation of Insulin Dosing Errors.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2018Article
- Strengths and Limitations of New Approaches for Graphical Presentation of Blood Glucose Monitoring System Accuracy Data.Journal of diabetes science and technology · 2017Article
- Accuracy Evaluation of 19 Blood Glucose Monitoring Systems Manufactured in the Asia-Pacific Region: A Multicenter Study.Journal of diabetes science and technology · 2017Article
- A Post-Marketing Surveillance Study to Evaluate Performance of the EXIMO™ Blood Glucose Monitoring System.Journal of clinical and diagnostic research : JCDR · 2017Article
- Surveillance of the System Accuracy of Two Systems for Self-Monitoring of Blood Glucose After Market Approval.Journal of diabetes science and technology · 2015Article
- Analytical Performance Requirements for Systems for Self-Monitoring of Blood Glucose With Focus on System Accuracy: Relevant Differences Among ISO 15197:2003, ISO 15197:2013, and Current FDA Recommendations.Journal of diabetes science and technology · 2015Review
- Performance of Cleared Blood Glucose Monitors.Journal of diabetes science and technology · 2015Review
- System Accuracy Evaluation of Four Systems for Self-Monitoring of Blood Glucose Following ISO 15197 Using a Glucose Oxidase and a Hexokinase-Based Comparison Method.Journal of diabetes science and technology · 2015Article
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
We investigated the analytical accuracy of 27 glucose monitoring systems (GMS) in a clinical setting, using the new ISO accuracy limits. In addition to measuring accuracy at blood glucose (BG) levels < 100 mg/dl and > 100 mg/dl, we also analyzed devices performance with respect to these criteria at 5 specific BG level ranges, making it possible to further differentiate between devices with regard to overall performance. Carbohydrate meals and insulin injections were used to induce an increase or decrease in BG levels in 37 insulin-dependent patients. Capillary blood samples were collected at 10-minute intervals, and BG levels determined simultaneously using GMS and a laboratory-based method. Results obtained via both methods were analyzed according to the new ISO criteria. Only 12 of 27 devices tested met overall requirements of the new ISO accuracy limits. When accuracy was assessed at BG levels < 100 mg/dl and > 100 mg/dl, criteria were met by 14 and 13 devices, respectively. A more detailed analysis involving 5 different BG level ranges revealed that 13 (48.1%) devices met the required criteria at BG levels between 50 and 150 mg/dl, whereas 19 (70.3%) met these criteria at BG levels above 250 mg/dl. The overall frequency of outliers was low. The assessment of analytical accuracy of GMS at a number of BG level ranges made it possible to further differentiate between devices with regard to overall performance, a process that is of particular importance given the user-centered nature of the devices' intended use.
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