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Info. Vol.12 - No.4 (2018.12.20)
Title Clinical Evaluation of a Low-pain Long Microneedle for Subcutaneous Insulin Injection
Authors Ghunil Lee1, Yonghao Ma2, Yong-ho Lee3 & Hyungil Jung1,2,4,*
Institutions 1Department of Biomaterials Science and Engineering, Yonsei University, Seoul, Republic of Korea
2Department of Biotechnology, Yonsei University, Seoul, Republic of Korea
3Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea
4Juvic Inc., 272 Digital-ro, Guro-gu, Seoul, Republic of Korea
*Correspondence and requests for materials should be addressed to H. Jung (hijung@yonsei.ac.kr)
Abstract Microneedles (MNs) are being developed to overcome the limitations of the conventional hypodermic needle, e.g. the injection pain. In this study, we conducted an analysis of clinical pain and bleeding at the site of MN insertion and evaluated the insulin pharmacodynamic profile compared with parameters obtained with a conventional pen needle. MN insertion into the skin of 25 healthy adults or 15 patients with type 2 diabetes (T2D) revealed significantly less pain relative to a conventional hypodermic pen needle, thus reducing pain scores from 2.1짹1.9 to 1.3짹1.4 (mean짹 standard deviation [SD]). Besides, no bleeding was observed when the MN was used. In the insulin pharmacodynamic assay, no significant differences were observed in the blood glucose-lowering effect between the pen needle and MN. Based on these results, the MN is expected to be a good substitute for conventional hypodermic pen needles and improve the quality of life of patients by significantly reducing the pain associated with insulin treatment.
Keyword Microneedle, Insulin, Subcutaneous injection, Pain, Bleeding, Pharmacodynamic profile
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