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.

中文翻译：

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新型最小化刺血针的微型刺血针的临床评估

糖尿病患者需要每天刺手指以自我监测血糖水平。由于刺痛，患者可能不愿意使用外径较大的市售刺血针。这导致他们的健康状况恶化。金属微针是商用柳叶刀系统的理想替代品，并提供了一种微创且对患者友好的毛细管血抽取方法。然而，很少有关于足够长和高刚度的微针用于进行临床试验的无害和有效毛细管血采样的性能的报道。在这里，我们开发了一种新颖的微型刺血针（ML），该刺血针长3 mm，外径为130 µm，尖锐的15°斜角尖端。与市售的ACCU-CHEK Softclix相比，ML在猪皮试验中引起的组织损伤更少。通过一项临床研究，我们证明了使用市售柳叶刀和ML进行的疼痛评分分别为数字疼痛评分量表的3.4和0.8。使用ML抽取的平均血液量为0.96 µL，满足了葡萄糖检测的最低要求（0.3 µL）。这种新型的ML可以通过减少刺血相关的疼痛来改善患者对血糖监测程序的依从性。