Human Factors Usability and Validation Studies of a Glucagon Autoinjector in a Simulated Severe Hypoglycemia Rescue Situation
Human Factors Usability and Validation Studies of a Glucagon Autoinjector in a Simulated Severe Hypoglycemia Rescue Situation
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DOI：
10.1089/dia.2019.0148
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发表时间：
2019-06-20
影响因子：
5.4
通讯作者：
Garibaldi, Mark
中科院分区：
文献类型：
--
作者：
Valentine, Virginia;Newswanger, Brett;Garibaldi, Mark
背景：一种室温稳定的、可溶的液体胰高血糖素制剂被加载到一个预填充的、一次性的、两步的自动注射器中，用于严重低血糖的抢救。我们报告了一个人为因素验证程序，评估胰高血糖素自动注射器（GAI） (Gvoke HypoPen (TM)；Xeris Pharmaceuticals, Inc., Chicago， IL)与市场上销售的用于治疗严重低血糖的胰高血糖素应急包（GEKs）。方法：对16名参与者进行了模拟使用人为因素可用性研究，其中包括有胰高血糖素给药经验的成年护理人员和急救人员。对75名志愿者进行了GAI的总结性人为因素验证研究。参与者接受了(1)有关设备和程序的培训，或(2)有时间单独阅读说明并熟悉设备。一周后，参与者返回进行一次独立的救援尝试，模拟对患有低血糖症的糖尿病患者的救援。参与者的行动记录了关键的救援任务和使用错误。结果：在可用性研究中，88%（14）的患者成功使用GAI进行抢救注射，而31%(5)的患者使用gek （P < 0.05）。GAI组的平均总抢救时间为47.9 s， GEKs组的平均总抢救时间为109.0 s （P < 0.05）。在验证性研究中，98.7%的患者成功使用GAI进行了抢救注射。总的来说，在受过训练的参与者和未受过训练的参与者之间，在照顾者和第一响应者之间，在成年人和青少年之间，没有任何模式的差异。结论：GAI和教学材料可以被预期用户正确、安全、有效地使用，这支持GAI作为gek替代品的持续发展。
Background: A room-temperature stable, soluble liquid glucagon formulation loaded into a prefilled, single-use, two-step autoinjector is under development for severe hypoglycemia rescue. We report a human factors validation program evaluating the glucagon autoinjector (GAI) (Gvoke HypoPen (TM); Xeris Pharmaceuticals, Inc., Chicago, IL) versus marketed glucagon emergency kits (GEKs) for managing severe hypoglycemia. Methods: A simulated-use human factors usability study was conducted with the GAI versus marketed GEKs in 16 participants, including adult caregivers and first responders, experienced with glucagon administration. A summative human factors validation study of the GAI was conducted with 75 volunteers. Participants were (1) trained on the device and procedure or (2) given time to individually read the instructions and familiarize themselves with the device. Participants returned a week later to perform an unaided rescue attempt that simulated rescue of patients with diabetes suffering a hypoglycemia emergency. Participant actions were recorded for critical rescue tasks and use errors. Results: In the usability study, 88% (14) successfully administered a rescue injection using the GAI versus 31% (5) using GEKs (P < 0.05). Mean total rescue time of use was 47.9 s with the GAI versus 109.0 s with GEKs (P < 0.05). In the validation study, 98.7% successfully administered the rescue injection using the GAI. Overall, there were no patterns of differences between trained versus untrained participants, between caregivers versus first responders or between adults versus adolescents. Conclusion: The GAI and instructional materials can be correctly, safely, and effectively used by intended user, which support continued development of the GAI as an alternative to GEKs.