Donsmark Morten, Herold Lars, Kristensen Carsten Mølgård
Novo Nordisk A/S, Virum, Denmark.
Diabetes Technol Ther. 2009 Sep;11(9):581-5. doi: 10.1089/dia.2008.0142.
Easy-to-use insulin devices are an important tool in the treatment of diabetes. In this study, injection force requirements and dosage scale displays were evaluated for NovoPen 3 and NovoPen 4 (both from Novo Nordisk A/S, Copenhagen, Denmark).
To simulate 5 years of expected lifetime usage, 5,475 injections were performed automatically. Before and after lifetime testing, the force required to expel 60 U of insulin from NovoPen 3 and NovoPen 4 with 30-gauge or 31-gauge needles was measured. To compare dosage scale displays, digital images of multiple settings were made, and the total inked areas of digits were converted to mm(2).
At baseline, the mean +/- SD injection force of NovoPen 4 was 9.14 +/- 0.87 N and 16.55 +/- 1.17 N, which was significantly lower (P < 0.001) than for NovoPen 3, at 18.36 +/- 1.06 N and 29.81 +/- 1.26 N, with the 30-gauge and 31-gauge needle, respectively. After simulated lifetime testing, mean +/- SD injection force was 10.93 +/- 0.77 N and 17.77 +/- 1.14 N for NovoPen 4, which was significantly lower than the injection force of 18.54 +/- 0.94 N and 31.69 +/- 1.98 N for NovoPen 3 (P < 0.001). The mean dosage scale digit size was 1.63 mm(2) for NovoPen 3 and 7.82 mm(2) for NovoPen 4, with a mean difference of 6.19 mm(2). The display for NovoPen 4 was 4.74 times larger (P < 0.001).
The mean injection force required to operate NovoPen 4 was reduced up to 50% compared with NovoPen 3 (P < 0.001), and the mean dosage display for NovoPen 4 was over four times larger than for NovoPen 3 (P < 0.001). Based on these findings, patients with diabetes who have manual or visual impairment should find it easier to dose insulin with NovoPen 4.
易于使用的胰岛素注射装置是糖尿病治疗中的重要工具。在本研究中，对诺和笔3和诺和笔4（均来自丹麦哥本哈根的诺和诺德公司）的注射力要求和剂量刻度显示进行了评估。
为模拟预期5年的使用寿命，自动进行了5475次注射。在使用寿命测试前后，测量了使用30号或31号针头从诺和笔3和诺和笔4中排出60单位胰岛素所需的力。为比较剂量刻度显示，拍摄了多个设置的数字图像，并将数字的总墨迹面积转换为平方毫米（mm²）。
在基线时，诺和笔4使用30号和31号针头时的平均±标准差注射力分别为9.14±0.87N和16.55±1.17N，显著低于诺和笔3，诺和笔3的注射力分别为18.36±1.06N和29.81±1.26N（P<0.001）。经过模拟使用寿命测试后，诺和笔4的平均±标准差注射力为10.93±0.77N和17.77±1.14N，显著低于诺和笔3的注射力18.54±0.94N和31.69±1.98N（P<0.001）。诺和笔3的剂量刻度数字平均大小为1.63mm²，诺和笔4为7.82mm²，平均差值为6.19mm²。诺和笔4的显示大4.74倍（P<0.001）。
与诺和笔3相比，操作诺和笔4所需的平均注射力降低了50%（P<0.001），诺和笔4的平均剂量显示比诺和笔3大4倍多（P<0.001）。基于这些发现，有手动或视觉障碍的糖尿病患者使用诺和笔4注射胰岛素应会更容易。
