Backfish Matthew, Kovalchick Kimberly, Albert Robert, Rosilio Myriam, Chigutsa Farai, Liao Birong
Eli Lilly and Company, Indianapolis, IN, USA.
J Diabetes Sci Technol. 2025 Jan 29:19322968241301760. doi: 10.1177/19322968241301760.
For people with diabetes on insulin injection therapy, insulin pen dose accuracy and reliability are key features. Dose accuracy of the Tempo Pen with attached Tempo Smart Button [Module] (the system) was tested for three doses under standard atmospheric conditions. Reliability and the ability of the Module to detect, store, and transmit dose-related data were also tested. The system met the International Organization for Standardization 11608-1:2014 requirements for dose accuracy at all doses. Mean (standard deviation) doses were 0.010 mL (0.002), 0.299 mL (0.002), and 0.597 mL (0.004) for the 0.010-mL, 0.300-mL, and 0.600-mL doses, respectively. The Module also met requirements for data transfer after every injection. The system accurately delivered doses and reliably captured and stored insulin dosing information.
对于接受胰岛素注射治疗的糖尿病患者而言，胰岛素笔的剂量准确性和可靠性是关键特性。配备了Tempo智能按钮[模块]（该系统）的Tempo笔的剂量准确性在标准大气条件下针对三种剂量进行了测试。还测试了该模块检测、存储和传输剂量相关数据的可靠性及能力。该系统在所有剂量下均符合国际标准化组织11608-1:2014对剂量准确性的要求。0.010 mL、0.300 mL和0.600 mL剂量的平均（标准差）剂量分别为0.010 mL（0.002）、0.299 mL（0.002）和0.597 mL（0.004）。该模块在每次注射后也符合数据传输要求。该系统能够准确输送剂量，并可靠地捕获和存储胰岛素给药信息。
