Klonoff David, Nayberg Irina, Thonius Marissa, See Florian, Abdel-Tawab Mona, Erbstein Frank, Haak Thomas
Diabetes Research Institute, Mills-Peninsula Health Services, San Mateo, CA, USA
Diabetes Research Institute, Mills-Peninsula Health Services, San Mateo, CA, USA.
J Diabetes Sci Technol. 2015 Aug 26;10(1):125-30. doi: 10.1177/1932296815601441.
To deliver insulin glargine 300 U/mL (Gla-300), the widely used SoloSTAR(®) pen has been modified to allow for accurate and precise delivery of required insulin units in one-third of the volume compared with insulin glargine 100 U/mL, while improving usability. Here we compare the accuracy and injection force of 3 disposable insulin pens: Gla-300 SoloSTAR(®), FlexPen(®), and KwikPen™.
For the accuracy assessment, 60 of each of the 3 tested devices were used for the delivery of 3 different doses (1 U, half-maximal dose, and maximal dose), which were measured gravimetrically. For the injection force assessment, 20 pens of each of the 3 types were tested twice at half-maximal and once at maximal dose, at an injection speed of 6 U/s.
All tested pens met the International Organization for Standardization (ISO) requirements for dosing accuracy, with Gla-300 SoloSTAR showing the lowest between-dose variation (greatest reproducibility) at all dose levels. Mean injection force was significantly lower for Gla-300 SoloSTAR than for the other 2 pens at both half maximal and maximal doses (P < .0271).
All tested pens were accurate according to ISO criteria, and the Gla-300 SoloSTAR pen displayed the greatest reproducibility and lowest injection force of any of the 3 tested devices.
为了注射甘精胰岛素300 U/mL（Gla-300），广泛使用的优伴笔（SoloSTAR®）已进行了改进，与100 U/mL的甘精胰岛素相比，能够以三分之一的体积精确递送所需的胰岛素单位，同时提高了易用性。在此，我们比较了3种一次性胰岛素笔的准确性和注射力：Gla-300优伴笔（SoloSTAR®）、诺和笔（FlexPen®）和快易笔（KwikPen™）。
在准确性评估中，3种受试装置各60支用于递送3种不同剂量（1 U、半最大剂量和最大剂量），通过重量法进行测量。在注射力评估中，3种类型的胰岛素笔各20支在半最大剂量下测试两次，在最大剂量下测试一次，注射速度为6 U/s。
所有受试笔均符合国际标准化组织（ISO）的给药准确性要求，Gla-300优伴笔在所有剂量水平下的剂量间差异最低（再现性最高）。在半最大剂量和最大剂量下，Gla-300优伴笔的平均注射力均显著低于其他2种笔（P < 0.0271）。
根据ISO标准，所有受试笔均准确，且Gla-300优伴笔在3种受试装置中显示出最高的再现性和最低的注射力。
