Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 May;13(3):507-513.
doi: 10.1177/1932296819841353. Epub 2019 Apr 11.

System Accuracy Assessment of a Blood Glucose Meter With Wireless Internet Access Associated With Unusual Hypoglycemia Patterns in Clinical Trials

Andreas Pfützner  1   2   3 , Filiz Demircik  1   2 , Valeria Kirsch  1   3 , Johannes Pfützner  1   4 , Stephanie Strobl  1 , Mina Hanna  1 , Jan Spatz  1   2 , Anke H Pfützner  2
Affiliations

System Accuracy Assessment of a Blood Glucose Meter With Wireless Internet Access Associated With Unusual Hypoglycemia Patterns in Clinical Trials

Andreas Pfützner et al. J Diabetes Sci Technol. 2019 May.

Abstract

Background: In recent randomized clinical trials, an unusual reporting pattern of glycemic data and hypoglycemic events potentially related to an internet enabled blood glucose meter (MyGlucoHealth, BGM) was observed. Therefore, this clinical study was conducted to evaluate the system accuracy of the BGM in accordance with the ISO15197:2015 guidelines with additional data collection.

Methods: To investigate system accuracy, 10 of 3088 devices and 6 of 23 strip lots, used in the trials, were selected by a randomization procedure and a standard repeatability assessment. YSI 2300 STAT Plus was used as the standard reference method. The samples were distributed as per the ISO15197:2015 recommendations with 20 additional samples in the hypoglycemic range. Each sample was tested with 6 devices and 6 strip lots with double determinations.

Results: Overall, 121 subjects with blood glucose values 26-423 mg/dL were analyzed, resulting in 1452 data points. In all, 186/1452 readings (12.8%) did not meet the ISO acceptance criteria. Data evaluated according to the FDA guidelines showed that 336/1452 (23.1%) readings did not meet the acceptance criteria. A clear bias toward elevated values was observed for BG <100 mg/dL (MARD: 11.0%).

Conclusions: The results show that the BGM, although approved according to standard regulatory guidelines, did not meet the level of analytical accuracy required for clinical treatment decisions according to ISO 15197:2015 and FDA requirements. In general, caution should be exercised before selection of BGMs for patients and in clinical trials.

Keywords: ISO15197:2015; blood glucose meter; system accuracy.

PubMed Disclaimer

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: AP received a research grant for study conduct from Novo Nordisk. AHP is the coworker and spouse of AP.

Figures

Figure 1.
Figure 1.
System accuracy analysis for the individual lots and the entire data set. The dotted lines represent the upper and lower ISO threshold of acceptance.
Figure 2.
Figure 2.
Bland-Altman plot for the entire data set.
Figure 3.
Figure 3.
Surveillance error grid analysis.
See this image and copyright information in PMC

References

    1. American Diabetes Association. Glycemic targets. Sec. 6. In standards of medical care in diabetes—2017. Diabetes Care. 2017;40(suppl 1):S48-S56. - PMC - PubMed
    1. Klonoff DC, Prahalad P. Performance of cleared blood glucose monitors. J Diabetes Sci Technol. 2015;9:895-910. - PMC - PubMed
    1. Klonoff DC, Parkes JL, Kovatchev BP, et al. Investigation of the accuracy of 18 marketed blood glucose monitors. Diabetes Care. 2018;41:1681-1688. - PubMed
    1. Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197. J Diabetes Sci Technol. 2012;6:1060-1075. - PMC - PubMed
    1. Baumstark A, Pleus S, Schmid C, Link M, Haug C, Freckmann G. Lot-to-lot variability of test strips and accuracy assessment of systems for self-monitoring of blood glucose according to ISO 15197. J Diabetes Sci Technol. 2012;6:1076-1086. - PMC - PubMed

Publication types

MeSH terms