Insulin treatment is necessary for many patients with type 2 diabetes, and its delivery must be safe and comfortable. This study evaluated patients’ safety and comfort when using a Gensulin^® delivery device, GensuPen (Bioton), a reusable insulin pen device for injecting Gensulin^® insulin among adult and elderly patients with type 2 diabetes. This was a 4-week multicenter, prospective, observational, open-label study in patients with diabetes mellitus type 2 who have recently started using a GensuPen. Overall, 10,309 patients (mean age: 63 ± 12.0 years; 47.9% female) were analyzed in this study. Of these, 2.5% had used an insulin delivery device before, and for 97.5%, GensuPen was the first delivery device they had used. Most (87.8%) of the patients rated the GensuPen as very good in setting the dose, 92.0% in confirmation of successful insulin administration, 80.9% in trigger location, and 75.0% in force needed for injection. The overall safety of the GensuPen use was high since severe hypoglycemia occurred only in 0.2% of the studied patients. There were 0.6% adverse events, none of which were serious. This real-life observation data shows that the GensuPen was well accepted and safe in this large patient population of adult and elderly patients with type 2 diabetes.

中文翻译：

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Gensulin®输送装置在大批成年和2型糖尿病患者中的安全性和舒适性的多中心，前瞻性，观察性开放性研究

对于许多2型糖尿病患者而言，胰岛素治疗是必需的，并且其输送必须安全，舒适。使用美康缓释时，该研究评估了患者的安全性和舒适^®递送装置，GensuPen（Bioton），用于注入美康缓释的可重复使用的胰岛素笔设备^®成年和老年2型糖尿病患者中的胰岛素。这是对最近开始使用GensuPen的2型糖尿病患者进行的为期4周的多中心，前瞻性，观察性，开放标签研究。本研究共分析了10,309名患者（平均年龄：63±12.0岁；女性为47.9％）。其中，有2.5％的人以前使用过胰岛素输送设备，而97.5％的GensuPen是他们使用的第一个输送设备。大多数患者（87.8％）认为GensuPen在设定剂量方面非常好，确认胰岛素成功施用的占92.0％，在触发位置的占80.9％，注射所需的力量为75.0％。使用GensuPen的总体安全性很高，因为仅0.2％的研究患者发生了严重的低血糖症。有0.6％的不良事件，没有一个是严重的。