Accuracy evaluation of 19 blood glucose monitoring systems manufactured in the Asia-Pacific region: a multicenter study
Open accessAbstract
Background: System accuracy of current blood glucose monitors (BGMs) in the market has already been evaluated extensively, yet mostly focused on European and North American manufacturers. Data on BGMs manufactured in the Asia-Pacific region remain to be established. In this study, we sought to assess the accuracy performance of 19 BGMs manufactured in the Asia-pacific region. Methods: A total of 19 BGMs were obtained from local pharmacies in China. The study was conducted at three hospitals located in the Asia-Pacific region. Measurement results of each system were compared with results of the reference instrument (YSI 2300 PLUS Glucose Analyzer), and accuracy evaluation was performed in accordance to the ISO 15197:2003 and updated 2015 guidelines. Radar plots, which is a new method, are described herein to visualize the analytical performance of the 19 BGMs evaluated. Consensus error grid is a tool for evaluating the clinical significance of the results. Results: The 19 BGMs resulted in a satisfaction rate between 83.5% and 100.0% within ISO 15197:2003 error limits, and between 71.3% and 100.0% within EN ISO 15197:2015 (ISO 15197:2013) error limits. Conclusions: Of the 19 BGMs evaluated, 12 met the minimal accuracy requirement of the ISO 15197:2003 standard, whereas only 4 met the tighter EN ISO 15197:2015 (ISO 15197:2013) requirements. Accuracy evaluation of BGMs should be performed regularly to maximize patient safety.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Independent international studies have shown variable postmarketing accuracy of capillary blood glucose monitors, with up to 50% not meeting current standards.
“Independent international studies have shown variable postmarketing accuracy of capillary blood glucose monitors, with up to 50% not meeting current standards.”
From Blood glucose monitoring devices: current considerations (2023) · cites this paper as [12]
The BGM Devices and Experimental Procedures sections describe testing monitors obtained from local pharmacies with fingertip capillary blood. The Results report variable accuracy, but 15 of 19 monitors—about 79%, not up to 50%—failed the newer ISO accuracy requirement. This paper is one multicenter study of Asia-Pacific-manufactured monitors, rather than evidence for the sentence's broader claim about international studies. (LLM, conf=0.89)
Experimental — accuracy not yet measuredA multicenter accuracy study evaluating one system reagent lot for each of 19 blood glucose monitoring systems manufactured in the Asia-Pacific region showed ≈79% (15 out of 19) of systems not meeting the accuracy requirements of ISO 15197.
“A multicenter accuracy study evaluating one system reagent lot for each of 19 BGMS manufactured in the Asia-Pacific region showed ≈79% (15 out of 19) of BGMS not meeting the accuracy requirements of ISO 15197.”
From System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015 (2020) · cites this paper as [30]
Newer blood glucose monitors have significantly improved accuracy.
“Newer blood glucose monitors have significantly improved accuracy.11,12”
From Blood glucose monitoring devices: current considerations (2023) · cites this paper as [12]
The Conclusions report the accuracy of 19 monitors against two ISO standards, but do not compare newer monitors with older ones. The Discussion says manufacturers still need to improve accuracy; neither passage establishes that accuracy has significantly improved over time (searched for newer monitors and improvement over time). (LLM, conf=0.73)
Experimental — accuracy not yet measured
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
The citation lists haven’t been fetched yet
References 27 · Cited by 15
Research works printed but not linked: 3
- [3]3. Consensus statement on self-monitoring of blood glucose. Diabetes Care. 1987;10(1):95-99.
- [21]21. Brazg RL, Klaff LJ, Parkin CG. Performance variability of seven commonly used self-monitoring of blood glucose sys- tems: clinical considerations for patients and providers. J Diabetes Sci Technol. 2013;7(1):144-152.
- [22]22. Kuo CY, Hsu CT, Ho CS, Su TE, Wu MH, Wang CJ. Accuracy and precision evaluation of seven self-monitoring blood glu- cose systems. Diabetes Technol Ther. 2011;13(5):596-600.
- Authors
- Yu-Fei, W., Wei-Ping, J., Ming-Hsun, W., Miao-O, C., Ming-Chang, H., Chi-Pin, W., & Ming-Shih, L.
- Affiliations
- Shanghai Jiao Tong University Affiliated Sixth People’s Hospital, Shanghai, China
- Shanghai Jiao Tong University (CN)
- Min Sheng General Hospital (TW)
- Chung Shan Medical University Hospital (TW)
- Clinical Laboratory, Chung Shan Medical University Hospital, Taichung, Taiwan
- Venue
- Journal of Diabetes Science and Technology
- Publisher
- SAGE Publications
- Published
- 2017-05-08
- Volume
- 11
- Issue
- 5
- Pages
- 953-965
- ISSN
- 1932-2968 (ISSN-L)
- PMC
- PMC5950995
- OpenAlex
- W2613031974
- Semantic Scholar
- c158c952f0e4623a2c4222286464cbb214289758
- Cited by
- 15
- References
- 27
- Citations by year
- 2025: 2 · 2024: 3 · 2023: 4 · 2022: 1 · 2020: 1 · 2019: 2 · 2018: 2
- FWCI
- 1.01
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Diabetes Science and Technology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- bionime corporation
- Topics
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hyperglycemia and glycemic control in critically ill and hospitalized patients
- Keywords
- blood glucose monitoring systems, meter accuracy, ISO 15197, diabetes self-management, radar plots, patient safety
- MeSH terms
- Adult, Aged, Aged, 80 and over, China, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Female, Humans, Male, Middle Aged, Blood Glucose Self-Monitoring, Reproducibility of Results, Young Adult
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
