Clinical Evaluation of a Novel Micro-lancet (ML) for Minimizing Lancing Pain

Abstract

Patients with diabetes are required to lance their fingers daily for self-monitoring their blood glucose level. Patients might be reluctant to use commercial lancets with thick outer diameters due to lancing pain; this results in the worsening of their health. A metallic microneedle is an ideal substitute to the commercial lancet system and offers a minimally invasive and patient friendly approach for capillary blood extraction. However, reports regarding the performance of sufficient long and high stiffness microneedles for innocuous and efficient capillary blood sampling for conducting clinical trials are rare. Here, we developed a novel micro-lancet (ML) that is 3 mm long and has a 130 µm outer diameter and a sharp beveled 15° tip. ML induced lesser tissue damage than the commercial ACCU-CHEK Softclix in a porcine skin test. Through a clinical study, we demonstrated that the pain scores using the commercial lancet and ML were 3.4 and 0.8 the numeric pain rating scale, respectively. The average blood volume drawn using the ML was 0.96 µL, which satisfies the minimum requirement (0.3 µL) for glucose detection. This novel ML may improve patient compliance to blood glucose monitoring procedures by reducing lancing-related pain.