TY - JOUR
T1 - A disposable tear glucose biosensor - Part 4
T2 - Preliminary animal model study assessing efficacy, safety, and feasibility
AU - La Belle, Jeffrey T.
AU - Engelschall, Erica
AU - Lan, Kenneth
AU - Shah, Pankti
AU - Saez, Neil
AU - Maxwell, Stephanie
AU - Adamson, Teagan
AU - Abou-Eid, Michelle
AU - McAferty, Kenyon
AU - Patel, Dharmendra R.
AU - Cook, Curtiss B.
N1 - Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was partially supported by ASU Fulton Undergraduate Research Initiatives program, Barrett, The Honors College, and seed funding from the Biodesign Institute at Arizona State University, Tempe, as well as a grant from BioAccel LLC.
PY - 2014/1
Y1 - 2014/1
N2 - 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.
AB - 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.
KW - Biosensor
KW - Diabetes mellitus, tear glucose monitoring, power analysis, sample size determination
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U2 - 10.1177/1932296813511741
DO - 10.1177/1932296813511741
M3 - Article
AN - SCOPUS:84900543009
SN - 1932-2968
VL - 8
SP - 109
EP - 116
JO - Journal of Diabetes Science and Technology
JF - Journal of Diabetes Science and Technology
IS - 1
ER -