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. 2008 Jul;2(4):595-602.
doi: 10.1177/193229680800200410.

Pilot studies of transdermal continuous glucose measurement in outpatient diabetic patients and in patients during and after cardiac surgery

Han Chuang  1 , My-Quyen Trieu, James Hurley, Elizabeth J Taylor, Michael R England, Stanley A Nasraway Jr
Affiliations

Pilot studies of transdermal continuous glucose measurement in outpatient diabetic patients and in patients during and after cardiac surgery

Han Chuang et al. J Diabetes Sci Technol. 2008 Jul.

Abstract

Background: We tested the hypothesis that glucose can be measured continuously and reliably in patients in diverse settings using a transdermal biosensor coupled to a permeated skin site. In addition, we compared a novel, abrasion-based skin permeation method to an ultrasound-based method for transdermal continuous glucose monitoring.

Method: Transdermal continuous glucose monitors were applied to patients with diabetes (study I), patients undergoing cardiac surgery (study II), and healthy volunteers (study III). Reference blood glucose measurements were performed with glucometers or standard blood glucose analyzers. At the conclusion of the 24-hour study, data were postprocessed for comparison with the reference blood glucose values collected during the study period.

Results: Data were validated for 10 subjects for 12 hours in study I, 8 subjects for 24 hours in study II, and 6 subjects in study III. The transdermal continuous glucose monitors usually required 1 hour of warm up. Depending on the study setting, single or multiple calibrations were applied to the datasets. Comparing predicted glucose versus reference blood glucose values, we found that study I yielded 89.6% in zone A and 9.0% in zone B in the Clarke error grid (222 data points), study II yielded 86.4% in zone A and 13.6% in zone B (147 data points), and study III yielded 89.9% in zone A and 10.1% in zone B (378 data points).

Conclusions: Continuous transdermal glucose monitoring was demonstrated successfully in diverse clinical settings. The performance of abrasion was equivalent to ultrasound skin permeation methodology for transdermal glucose monitoring.

Keywords: biosensor; continuous glucose; diabetes; intensive care; tight glycemic; transdermal.

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Figures

Figure 1
Figure 1
Symphony™ tCGM system and operation.
Figure 2
Figure 2
CEG analysis using biosensor configuration A on 10 patients with diabetes in a home care-mimicking clinical setting for 12 hours.
Figure 3
Figure 3
BG–biosensor profiles of patients with diabetes with higher (a) and lower (b) glucose levels. The continuous biosensor measurements follow the reference BG values closely in both cases.
Figure 4
Figure 4
CEG analysis using biosensor configuration C on eight subjects in a surgical critical care setting for up to 24 hours.
Figure 5
Figure 5
BG–biosensor profiles of one patient undergoing cardiac surgery (a) and another patient in CTU (b). The continuous biosensor measurements follow the reference BG values closely in both cases.
Figure 6
Figure 6
Comparison of SonoPrep and Prelude skin permeation methods for tCGM application. These data were collected from the same subject showing equivalent performance of the two skin permeation methods.
See this image and copyright information in PMC

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