Waldenmaier Delia, Zschornack Eva, Kalt Lucas, Buhr Andreas, Pleus Stefan, Haug Cornelia, Freckmann Guido
1 Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
2 Ypsomed AG, Burgdorf, Switzerland.
J Diabetes Sci Technol. 2019 Jan;13(1):96-102. doi: 10.1177/1932296818785386. Epub 2018 Jul 12.
A new insulin pump system was tested under everyday conditions for user evaluation and safety assessment prior to its launch in Europe. This insulin pump is focused on easy handling and uses prefilled cartridges.
The pump system was used by 35 adult subjects with type 1 diabetes, experienced in insulin pump therapy, under everyday conditions for approximately one month each. All subjects rated various aspects of the system after home use; technical issues and safety parameters were assessed throughout the study.
All 35 subjects completed the study as planned and used the system for a total of 1013 days. After home use, 74% of the subjects were very satisfied or quite satisfied with the new pump. The subjects confirmed that the system is easy to use, especially considering general handling, bolus delivery and basal rate settings, infusion set, and cartridge change. Potential for improvements was seen in the touchscreen, warnings and alarms, the blind bolus function, the availability of a bolus calculator (was not available at time of study), and the cartridge size as rated by the study participants. Safety analysis did not raise any concerns for the use of this system.
The majority of the users testing the system were satisfied with the novel insulin pump system and the system was safe for use under everyday conditions by this study population.
一种新型胰岛素泵系统在欧洲推出之前,在日常条件下进行了测试,以进行用户评估和安全性评估。这种胰岛素泵注重操作简便,并使用预填充药筒。
35名患有1型糖尿病且有胰岛素泵治疗经验的成年受试者在日常条件下使用该泵系统,每人使用约一个月。所有受试者在家庭使用后对系统的各个方面进行了评分;在整个研究过程中评估了技术问题和安全参数。
所有35名受试者均按计划完成了研究,该系统总共使用了1013天。家庭使用后,74%的受试者对新泵非常满意或相当满意。受试者确认该系统易于使用,特别是在一般操作、大剂量输注和基础率设置、输液器和药筒更换方面。研究参与者认为,触摸屏、警告和警报、盲注功能、大剂量计算器的可用性(研究时不可用)以及药筒尺寸仍有改进的空间。安全性分析未对该系统的使用提出任何担忧。
测试该系统的大多数用户对新型胰岛素泵系统感到满意,并且该系统在本研究人群的日常条件下使用是安全的。