Neves Ana Lúcia Domingues, Martins Luiz Eduardo Galvão, Gabbay Mônica Andrade Lima, Cavicchioli Gabriela, Tenorio Fernanda Silva, Cunha Tatiana Sousa
Postgraduate Program in Translational Medicine, Department of Medicine, Paulista School of Medicine, Federal University of São Paulo, São Paulo/SP, Brazil.
Institute of Science and Technology, Federal University of São Paulo, São Paulo/SP, Brazil.
J Diabetes Sci Technol. 2024 Jan;18(1):74-81. doi: 10.1177/19322968221106196. Epub 2022 Jun 30.
Since the introduction of continuous subcutaneous insulin infusion (CSII), the benefits have been numerous. However, adverse events (AEs) are experienced by up to 40% of users per year, exposing them to potentially fatal risks. The available evidence on the variables that trigger AEs associated with CSII remains limited, indicating the importance of studies on the subject.
To propose a taxonomy based on the prevalent AEs experienced by patients from a reference diabetes mellitus (DM) center in Brazil using different CSII devices.
118 patients participated in an online interview and answered the questions of the data collection instrument. Identifying categories and subcategories of analysis contributed to constructing the AEs taxonomy.
The five analysis categories identified were: CSII User Interface (n = 45), CSII Alert System (n = 13), CSII Software and Connection (n = 11), CSII Durability (n = 30), and Electrical and Mechanical System of CSII (n = 60) A total of 159 AEs were identified, including conflicting alert messages and error/warning notification failures, errors resulting from engine malfunctions, data loss, patient interface deficiencies, button problems, and battery failure.
The study describes in a taxonomic format the AEs directly associated with the use of modern CSIIs that may contribute with additional information to the Food and Drug Administration (FDA) Medical Device Report (MDR) adverse event codes. In addition to guiding educational actions in the treatment of DM and providing information for health professionals and medical device developers, prospective studies examining the frequency of such problems, including the potential psychosocial impact of this technologically advanced therapy, are needed.
自持续皮下胰岛素输注（CSII）引入以来，其益处众多。然而，每年多达40%的使用者会经历不良事件（AE），使他们面临潜在的致命风险。关于引发与CSII相关不良事件的变量的现有证据仍然有限，这表明对此主题进行研究的重要性。
基于巴西一家参考糖尿病（DM）中心使用不同CSII设备的患者所经历的常见不良事件，提出一种分类法。
118名患者参与了在线访谈，并回答了数据收集工具中的问题。确定分析类别和子类别有助于构建不良事件分类法。
确定的五个分析类别为：CSII用户界面（n = 45）、CSII警报系统（n = 13）、CSII软件与连接（n = 11）、CSII耐用性（n = 30）以及CSII电气和机械系统（n = 60）。总共识别出159起不良事件，包括相互冲突的警报消息和错误/警告通知失败、发动机故障导致的错误、数据丢失、患者界面缺陷、按钮问题以及电池故障。
该研究以分类法的形式描述了与现代CSII使用直接相关的不良事件，这些事件可能为美国食品药品监督管理局（FDA）医疗器械报告（MDR）不良事件代码提供额外信息。除了指导糖尿病治疗中的教育行动以及为卫生专业人员和医疗器械开发者提供信息外，还需要进行前瞻性研究，以检查此类问题的发生频率，包括这种技术先进疗法的潜在社会心理影响。
