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首页> 美国卫生研究院文献>Diabetes Technology Therapeutics >FlexTouch: An Insulin Pen-Injector with a Low Activation Force Across Different Insulin Formulations Needle Technologies and Temperature Conditions
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FlexTouch: An Insulin Pen-Injector with a Low Activation Force Across Different Insulin Formulations Needle Technologies and Temperature Conditions

机译：FlexTouch：一种胰岛素笔式注射器在不同的胰岛素配方针头技术和温度条件下具有较低的激活力

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摘要

FlexTouch® (Novo Nordisk A/S, Bagsvaerd, Denmark) is a pen-injector with a torque spring mechanism requiring a low activation force. This laboratory-based study compared the activation force of FlexTouch during the injection of insulin with different needles and at temperature conditions within the range at which the device is recommended for use. Using a tensile tester, activation force was measured at maximum dose settings for insulin detemir (100 U/mL) and insulin degludec (100 and 200 U/mL) at standard (23°C ± 5°C), cool (5°C ± 3°C), and warm (30°C ± 2°C) conditions. Activation force was measured with two 32-gauge needles differing in internal diameter at standard conditions. At standard, cool, and warm conditions, estimated mean activation forces with 95% confidence interval were 5.71 newtons (N) (5.63–5.79), 5.94 N (5.83–6.06), and 5.69 N (5.58–5.80) with insulin detemir, 5.53 N (5.45–5.62), 5.56 N (5.44–5.67), and 5.33 N (5.22–5.44) with 100 U/mL insulin degludec, and 5.53 N (5.45–5.61), 5.83 N (5.71–5.94), and 5.56 N (5.45–5.68) with 200 U/mL insulin degludec, respectively. Mean activation forces were observed to be low with very small variability between measurements; however, the differences between insulins and temperature conditions were statistically significant. The activation force required by FlexTouch remained low across all situations tested. The differences between activation force needed with different insulins and temperature conditions were small and unlikely to be clinically meaningful.
机译：FlexTouch®（丹麦Bagsvaerd，Novo Nordisk A / S）是一种笔形注射器，其扭矩弹簧机构所需的驱动力较小。这项基于实验室的研究比较了FlexTouch在使用不同针头注射胰岛素期间以及在推荐使用该设备的温度范围内的温度条件下的激活力。使用拉伸测试仪在标准剂量（23°C±±5°C）和凉爽（5°C）的最大剂量设置下测定胰岛素的特地米尔（100 U / mL）和胰岛素地高卢德（100和200 U / mL）的激活力（±3°C）和温暖（30°C±2°C）条件下。在标准条件下，用两个内径不同的32号针头测量激活力。在标准，凉爽和温暖的条件下，使用地特胰岛素时，估计的平均激活力（置信区间为95％）为5.71牛顿（N）（5.63-5.79），5.94 N（5.83-6.06）和5.69 N（5.58-5.80）， 5.53 N（5.45-5.62），5.56 N（5.44-5.67）和5.33 N（5.22-5.44）和100 U / mL胰岛素地格列克，5.53 N（5.45-5.61），5.83 N（5.71-5.94）和5.56 N（5.45-5.68）分别配以200 U / mL胰岛素地格列酮。观察到平均激活力很低，测量之间的差异很小。但是，胰岛素和温度条件之间的差异具有统计学意义。在所有测试情况下，FlexTouch所需的激活力均保持较低。不同胰岛素所需的激活力与温度条件之间的差异很小，并且不太可能具有临床意义。

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