Characterization and Clinical Trial of an Innovative High-Speed Lancing Device

Abstract

An innovative high-speed lancing device has a lancet that moves so fast that it is not affected at all by the vibration of its spring, and does not pierce the skin repeatedly, greatly reducing the pain that is caused to diabetes mellitus (DM) patients during blood sampling. As revealed by experimental measurements of the acceleration of a lancet using an accelerometer, the lancet pierces the skin only once. The maximum acceleration and the instant piercing velocity of the lancet are 9.4 times and 1.78 times those of a conventional lancing device, respectively. Meanwhile, the period for which the lancet remains in the skin is 0.014 s shorter than that of the conventional lancing device. A clinical trial that involved 100 participants yielded statistical results concerning the numeric rating of pain scale (NRS) of pain intensity, which is internationally recognized as the pain with the highest validity, that showed that the NRS of participants who used the innovative high-speed lancing device was 2.65 less than that of those who used the conventional lancing device, and the duration of the pain after blood sampling was 76.1 min shorter.