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Performance of Cleared Blood Glucose Monitors
David C Klonoff1, Priya Prahalad2
1Diabetes Research Institute, Mills-Peninsula Health Services, San Mateo, CA, USA dklonoff@diabetestechnology.org.
Journal of Diabetes Science and Technology
|May 21, 2015
Summary
Many blood glucose monitors (BGMs) fail accuracy standards, impacting diabetes management. This review highlights significant performance issues with cleared BGM systems, leading to clinical and economic risks.
Area of Science:
- Medical Devices
- Diabetes Technology
- Regulatory Science
Background:
- Cleared blood glucose monitor (BGM) systems are crucial for diabetes self-management.
- Ensuring the accuracy of BGM performance is vital for safe and effective treatment decisions.
Purpose of the Study:
- To evaluate the performance accuracy of cleared blood glucose monitor systems against international standards.
- To assess the clinical and economic risks associated with inaccurate BGM readings.
Main Methods:
- Conducted a literature review of publications from 2010-2014 assessing BGM performance against ISO 15197:2003 and ISO 15197:2013 standards.
- Reviewed literature on the clinical and economic consequences of inaccurate BGM data.
Main Results:
- Of 98 unique BGM systems reviewed, only 54% met ISO 15197:2003 and 32% met ISO 15197:2013 accuracy standards.
- Among 33 FDA-cleared BGM systems, 75% met ISO 15197:2003, but only 48.3% met the stricter ISO 15197:2013 standards.
- FDA-cleared systems were more likely to meet both standards compared to non-FDA-cleared systems.
Conclusions:
- A significant percentage of cleared blood glucose monitors do not meet established international accuracy standards.
- Inaccurate BGM performance poses considerable clinical and economic risks for individuals with diabetes.
- There is a need for improved BGM accuracy and regulatory oversight to ensure patient safety.
