Minimally Invasive Insulin Delivery in Subjects with Type 1 Diabetes Using Hollow Microneedles
Minimally Invasive Insulin Delivery in Subjects with Type 1 Diabetes Using Hollow Microneedles
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DOI：
10.1089/dia.2008.0103
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发表时间：
2009-06-01
影响因子：
5.4
通讯作者：
Prausnitz, Mark R.
中科院分区：
文献类型：
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作者：
Gupta, Jyoti;Felner, Eric I.;Prausnitz, Mark R.
背景：先前已使用注射针将胰岛素输送至动物模型，但未用于人类受试者。本研究测试的假设，空心微针可以提供胰岛素，以调节血糖水平的受试者与1型糖尿病在微创missilingmarty.Methods：本研究进行了两个成年人与1型糖尿病和评估大剂量输注赖脯胰岛素使用空心微针相比，导管输液器（9毫米）。该研究首先通过从插入禁食受试者皮肤1、3.5和5 mm的微针施用胰岛素来确定最小胰岛素递送深度，然后评估从插入皮肤1 mm的微针递送胰岛素以降低餐后葡萄糖水平的功效。血液样本定期测定血浆游离胰岛素和血浆葡萄糖水平长达3.5小时。结果：研究的第一阶段表明，微针插入在最浅的深度1毫米内的皮肤导致快速胰岛素吸收和葡萄糖水平的降低。在第二阶段进行大剂量胰岛素输注，然后食用标准餐，表明微针可有效降低餐后血糖水平。受试者报告没有疼痛的微针治疗，也没有不良事件。结论：这项研究提供了第一个概念证明，空心微针可以有效地提供餐时胰岛素1型糖尿病受试者在微创的方式。
Background: Microneedles have previously been used to deliver insulin to animal models, but not in human subjects. This study tested the hypothesis that hollow microneedles can deliver insulin to modulate blood glucose levels in subjects with type 1 diabetes in a minimally invasive manner.Methods: This study was carried out in two adults with type 1 diabetes and evaluated bolus delivery of lispro insulin using a hollow microneedle compared to a catheter infusion set (9 mm). The study first determined the minimum insulin delivery depth by administering insulin from microneedles inserted 1, 3.5, and 5 mm into the skin of fasting subjects and then assessed the efficacy of insulin delivery from microneedles inserted 1 mm into the skin to reduce postprandial glucose levels. Blood samples were periodically assayed for plasma free insulin and plasma glucose levels for up to 3.5 h.Results: The first phase of the study indicated that microneedles inserted at the shallowest depth of 1 mm within the skin led to rapid insulin absorption and reduction in glucose levels. Bolus insulin delivery followed by consumption of a standardized meal in the second phase revealed that microneedles were effective in reducing postprandial glucose levels. Subjects reported no pain from microneedle treatments, and there were no adverse events.Conclusions: This study provides the first proof of concept that hollow microneedles can effectively deliver bolus insulin to type 1 diabetes subjects in a minimally invasive manner.