Performance of Cleared Blood Glucose Monitors
Open accessAbstract
Cleared blood glucose monitor (BGM) systems do not always perform as accurately for users as they did to become cleared. We performed a literature review of recent publications between 2010 and 2014 that present data about the frequency of inaccurate performance using ISO 15197 2003 and ISO 15197 2013 as target standards. We performed an additional literature review of publications that present data about the clinical and economic risks of inaccurate BGMs for making treatment decisions or calibrating continuous glucose monitors (CGMs). We found 11 publications describing performance of 98 unique BGM systems. 53 of these 98 (54%) systems met ISO 15197 2003 and 31 of the 98 (32%) tested systems met ISO 15197 2013 analytical accuracy standards in all studies in which they were evaluated. Of the tested systems, 33 were identified by us as FDA-cleared. Among these FDA-cleared BGM systems, 24 out of 32 (75%) met ISO 15197 2003 and 15 out of 31 (48.3%) met ISO 15197 2013 in all studies in which they were evaluated. Among the non-FDA-cleared BGM systems, 29 of 65 (45%) met ISO 15197 2003 and 15 out of 65 (23%) met ISO 15197 2013 in all studies in which they were evaluated. It is more likely that an FDA-cleared BGM system, compared to a non-FDA-cleared BGM system, will perform according to ISO 15197 2003 (χ 2 = 6.2, df = 3, P = 0.04) and ISO 15197 2013 (χ 2 = 11.4, df = 3, P = 0.003). We identified 7 articles about clinical risks and 3 articles about economic risks of inaccurate BGMs. We conclude that a significant proportion of cleared BGMs do not perform at the level for which they were cleared or according to international standards of accuracy. Such poor performance leads to adverse clinical and economic consequences.
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Accuracy studies published in peer-reviewed journals are not available for some non-iCGM-approved CGM devices.
“For instance, accuracy studies published in peer-reviewed journals are not available for some devices, and the result is that their pivotal accuracy studies for regulatory clearance might not be replicated in independent studies.32,33”
From Importance of FDA-integrated continuous glucose monitors to ensure accuracy of continuous glucose monitoring (2025) · cites this paper as [32]
Pivotal accuracy studies for regulatory clearance of some non-iCGM-approved CGM devices might not be replicated in independent studies.
“For instance, accuracy studies published in peer-reviewed journals are not available for some devices, and the result is that their pivotal accuracy studies for regulatory clearance might not be replicated in independent studies.32,33”
From Importance of FDA-integrated continuous glucose monitors to ensure accuracy of continuous glucose monitoring (2025) · cites this paper as [32]
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References 25 · Cited by 59
Research works printed but not linked: 1
- Schnell O, Hinzmann R, Kulzer B, et al. Assessing the analytical performance of systems for self-monitoring of blood glucose: concepts of performance evaluation and definition of metro- logical key terms. J Diabetes Sci Technol. 2013;7(6):1585- 1594.
- Authors
- Klonoff, D. C., & Prahalad, P.
- Affiliations
- Mills Peninsula Health Services (US)
- University of California, San Francisco (US)
- Venue
- Journal of Diabetes Science and Technology
- Publisher
- SAGE Publications
- Published
- 2015-06-08
- Volume
- 9
- Issue
- 4
- Pages
- 895-910
- ISSN
- 1932-2968 (ISSN-L)
- PMC
- PMC4525666
- OpenAlex
- W2152126188
- Cited by
- 59
- References
- 25
- Citations by year
- 2024: 3 · 2022: 2 · 2021: 3 · 2020: 9 · 2019: 11 · 2018: 10 · 2017: 11 · 2016: 7 · 2015: 3
- FWCI
- 1.55
- 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
- Bayer HealthCare
- National Institutes of Health (5t32dk007161-48)
- National Institute of Diabetes and Digestive and Kidney Diseases (T32-DK-007161)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hyperglycemia and glycemic control in critically ill and hospitalized patients
- Keywords
- blood glucose meters, ISO 15197, analytical accuracy, FDA clearance, continuous glucose monitors, calibration, clinical risk, economic risk, diabetes management
- MeSH terms
- Algorithms, Blood Glucose, Calibration, Diabetes Mellitus, Humans, Insulin, Product Surveillance, Postmarketing, Reference Standards, United States, United States Food and Drug Administration, Blood Glucose Self-Monitoring, Reproducibility of Results
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