A disposable tear glucose biosensor - Part 4: Preliminary animal model study assessing efficacy, safety, and feasibility

Jeffrey T. La Belle, Erica Engelschall, Kenneth Lan, Pankti Shah, Neil Saez, Stephanie Maxwell, Teagan Adamson, Michelle Abou-Eid, Kenyon McAferty, Dharmendra R. Patel, Curtiss B. Cook

Research output: Contribution to journalArticle

7 Scopus citations

Abstract

Objective: A prototype tear glucose (TG) sensor was tested in New Zealand white rabbits to assess eye irritation, blood glucose (BG) and TG lag time, and correlation with BG. Methods: A total of 4 animals were used. Eye irritation was monitored by Lissamine green dye and analyzed using image analysis software. Lag time was correlated with an oral glucose load while recording TG and BG readings. Correlation between TG and BG were plotted against one another to form a correlation diagram, using a Yellow Springs Instrument (YSI) and self-monitoring of blood glucose as the reference measurements. Finally, TG levels were calculated using analytically derived expressions. Results: From repeated testing carried over the course of 12 months, little to no eye irritation was detected. TG fluctuations over time visually appeared to trace the same pattern as BG with an average lag times of 13 minutes. TG levels calculated from the device current measurements ranged from 4 to 20 mg/dL and correlated linearly with BG levels of 75-160 mg/dL (TG = 0.1723 BG = 7.9448 mg/dL; R2 = .7544). Conclusion: The first steps were taken toward preliminary development of a sensor for self-monitoring of tear glucose (SMTG). No conjunctival irritation in any of the animals was noted. Lag time between TG and BG was found to be noticeable, but a quantitative modeling to correlate lag time in this study is unnecessary. Measured currents from the sensors and the calculated TG showed promising correlation to BG levels. Previous analytical bench marking showed BG and TG levels consistent with other literature.

Original languageEnglish (US)
Pages (from-to)109-116
Number of pages8
JournalJournal of Diabetes Science and Technology
Volume8
Issue number1
DOIs
StatePublished - Jan 2014

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Keywords

  • Biosensor
  • Diabetes mellitus, tear glucose monitoring, power analysis, sample size determination

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Bioengineering
  • Biomedical Engineering

Cite this

La Belle, J. T., Engelschall, E., Lan, K., Shah, P., Saez, N., Maxwell, S., Adamson, T., Abou-Eid, M., McAferty, K., Patel, D. R., & Cook, C. B. (2014). A disposable tear glucose biosensor - Part 4: Preliminary animal model study assessing efficacy, safety, and feasibility. Journal of Diabetes Science and Technology, 8(1), 109-116. https://doi.org/10.1177/1932296813511741