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连接胰岛素笔系统的剂量准确性和可靠性

Matthew Backfish¹, Kimberly Kovalchick¹, Robert Albert¹

¹Eli Lilly and Company, Indianapolis, IN, USA.

Journal of diabetes science and technology

|January 30, 2025

概括

带有智能按的Tempo Pen系统准确地提供胰岛素剂量,可靠地记录注射数据,符合糖尿病护理的国际标准.

科学领域:

医疗器械医疗器械
糖尿病技术技术
制药工程制药工程

背景情况:

胰岛素笔注射治疗对于糖尿病管理至关重要.
剂量准确性和可靠性对于有效的胰岛素治疗至关重要.
带有Tempo智能按的Tempo Pen系统旨在提高胰岛素的输送速度.

研究的目的:

为了评估Tempo Pen系统的剂量准确性.
评估Tempo智能按在数据检测,存储和传输方面的可靠性.
确保遵守国际标准化组织 (ISO) 的标准.

主要方法:

在标准大气条件下,使用Tempo智能按测试Tempo Pen系统.
评估三种特定胰岛素剂量的准确性.
评估模块在检测,存储和传输剂量数据方面的性能.
将结果与ISO 11608-1:2014要求进行比较.

主要成果:

该Tempo Pen系统满足了ISO 11608-1:2014对所有测试剂量的剂量准确性的要求.
交付的平均剂量为0.010毫升 (0.002毫升SD),0.299毫升 (0.002毫升SD) 和0.597毫升 (0.004毫升SD).
智能按模块在每次注入后成功满足了数据传输要求.

结论:

泰莫笔系统展示了精确的胰岛素剂量传递.
集成的智能按可靠地捕获和存储必要的胰岛素剂量信息.
该系统为糖尿病管理中的胰岛素注射治疗提供了可靠的解决方案.

关键词:

时间时间时间时间时间时间节奏智能按节奏智能按连接的胰岛素笔连接到胰岛素笔.自己管理的自我管理.

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