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Figure 1.

Sample nerve conduction recordings from standard NCS (A) and the point-of-care device (B) from a 60-year-old female with type 2 diabetes and an image of the point-of-care procedure (C).

Panel A: Sample standard NCS recording. Sural nerve amplitude potential was 6.8 µV and conduction velocity was 48.3 m/s. Panel B: Sample recording from the point-of-care device. Sural nerve amplitude potential was 8 µV and conduction velocity was 56 m/s. Panel C: The device was placed on the lateral aspect of the leg and the sural nerve was stimulated and recorded by the electrical probes and biosensor, respectively.

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Table 1.

Clinical characteristics of 44 subjects with type 1 and type 2 diabetes.

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Table 2.

Intra- and interrater reliability of the sural nerve amplitude potential and conduction velocity using the point-of-care device for 44 subjects with type 1 and type 2 diabetes.

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Table 2 Expand

Figure 2.

Scatterplots (A,B) and Bland-Altman plots (C,D) for comparison of the point-of-care nerve conduction method versus standard NCS for SNAP or SNCV.

Panels A and B: Scatterplot of SNAP (A) and SNCV (B) showing the line of unity (diagonal solid line) between the two methods. Panels C and D: The Bland-Altman plots demonstrating the mean difference (depicted by the solid line) between SNAP (C) or SNCV (D) obtained by the two methods. Points above or below zero on the y-axis represent over- and underestimation by the point-of-care device, respectively. The dotted lines represent the upper and lower limits of the 85% confidence interval. Unrecordable SNCV results for both nerve conduction methods were assigned a value of 30.4 m/s, representing the lowest value in the dataset. Such data handling was applied to 9 values for standard NCS and 3 values for the point-of-care device.

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Figure 3.

ROC curve showing the diagnostic validity of the point-of-care device for the identification of DSP as defined by electrophysiological criteria from standard NCS.

An optimal threshold of one abnormality in SNAP or SNCV (*) had a sensitivity and specificity of 95% and 71%, respectively. An optimal threshold of abnormalities in both parameters (†) had a sensitivity and specificity of 67% and 89%, respectively.

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