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In Vitro Sugar Interference Testing With Amperometric Glucose Oxidase Sensors
Ryan Boehm1, John Donovan1,2, Disha Sheth1,3
11 Division of Biology, Chemistry, and Material Science (DBCMS), Office of Science and Engineering Laboratories (OSEL), Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA), Silver Spring, MD, USA.
Journal of Diabetes Science and Technology
|August 4, 2018
Summary
Continuous glucose monitors (CGMs) using glucose oxidase (GOx) sensors showed minimal interference from most compounds. Galactose interference was low at physiological concentrations, suggesting enzyme reactivity and impurities as key factors in sensor accuracy.
Area of Science:
- Biomedical Engineering
- Analytical Chemistry
- Biochemistry
Background:
- Continuous glucose monitors (CGMs) are vital for diabetes management, tracking glucose levels in interstitial fluid.
- Current CGMs utilize glucose oxidase (GOx) electrochemical detection, which can be susceptible to interference from various substances.
- Ensuring the accuracy of CGMs requires understanding potential interfering agents and their impact on sensor performance.
Purpose of the Study:
- To evaluate the in vitro interference of various compounds, including sugars, sugar alcohols, and artificial sweeteners, on amperometric glucose oxidase (GOx) sensors.
- To investigate the interference of galactose, a potential interfering agent, at both supra-physiologic and physiologically relevant concentrations.
- To elucidate the mechanisms of sugar interference with GOx-based glucose sensors through enzyme kinetic analysis.
Main Methods:
- In vitro screening of 17 compounds (sugars, sugar alcohols, artificial sweeteners) for interference with GOx sensors.
- Detailed investigation of galactose interference using a custom amperometric system at physiologically relevant concentrations.
- Enzyme kinetic analysis (Michaelis-Menten and Hill equation) of glucose and galactose interactions with GOx enzymes.
Main Results:
- Most screened compounds showed minimal interference (MARD ≤ 20%) at high concentrations, except for galactose, xylose, and mannose.
- Galactose exhibited significant CGM-dependent interference (MARD 47-72%) at higher concentrations but minimal interference (MRD 6.9%) at physiologically relevant levels (0.1-10 mg/dL).
- Enzyme kinetic analysis provided key parameters (Vmax, Km, h) for glucose and galactose, offering insights into their interaction with GOx.
Conclusions:
- Galactose interference with CGMs is minimal at physiologically relevant concentrations, despite higher interference observed during initial screening.
- Potential sources of sugar interference in GOx glucose sensors include the enzyme's reactivity towards non-glucose sugars and the presence of enzymatic impurities like galactose oxidase.
- These findings underscore the importance of considering enzyme kinetics and potential impurities during the development of accurate and reliable glucose sensing devices.
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