Diabetes Digital App Technology: Benefits, Challenges, and Recommendations. A Consensus Report by the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) Diabetes Technology Working Group
Diabetes Digital App Technology: Benefits, Challenges, and Recommendations. A Consensus Report by the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) Diabetes Technology Working Group
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DOI：
10.2337/dci19-0062
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发表时间：
2020-01-01
期刊：
影响因子：
16.2
通讯作者：
Heinemann, Lutz
中科院分区：
文献类型：
--
作者：
Fleming, G. Alexander;Petrie, John R.;Heinemann, Lutz
数字健康技术，特别是数字和健康应用程序（“应用程序”），一直在快速发展，以帮助人们管理他们的糖尿病。智能手机和其他无线设备上提供的许多与健康相关的应用程序可用于支持需要根据血糖监测数据采取生活方式干预或药物调整的糖尿病患者。然而，法规和指南还没有赶上新兴领域，以标准化如何审查和监测移动的健康应用程序的患者安全性和临床有效性。关于移动的健康应用程序的安全性和有效性的现有证据仍然有限，特别是对于糖尿病。因此，欧洲糖尿病研究协会（EASD）和美国糖尿病协会（ADA）对现有糖尿病数字健康技术的现状进行了联合审查（仅适用于独立的糖尿病应用程序，而不是与受监管医疗器械（如胰岛素泵、持续葡萄糖监测系统）不可或缺的应用程序，和自动胰岛素输送系统）以及监管机构和组织的实践。我们发现，在美国和欧洲，用于管理健康和保健的移动的应用程序基本上不受监管，除非它们符合用于治疗和/或诊断目的的医疗器械的定义。包括国际医疗器械监管机构论坛和世界卫生组织在内的国际组织在对不同类型的数字健康技术进行分类以及将数字健康技术整合到医疗器械领域方面取得了长足的进步。随着糖尿病数字健康领域的不断发展，并更充分地融入日常生活，我们希望确保其基于安全性和有效性的最佳证据。因此，我们揭示了糖尿病社区，包括监管机构，政策制定者，专业组织，研究人员，糖尿病患者和医疗保健专业人员需要解决的几个问题，以确保糖尿病健康技术能够充分发挥其潜力。这些问题包括应用程序准确性和临床有效性的证据不足，缺乏培训，互操作性和标准化差以及数据安全性不足。最后，我们建议采取一系列行动来解决其中的一些缺点。
Digital health technology, especially digital and health applications ("apps"), have been developing rapidly to help people manage their diabetes. Numerous health-related apps provided on smartphones and other wireless devices are available to support people with diabetes who need to adopt either lifestyle interventions or medication adjustments in response to glucose-monitoring data. However, regulations and guidelines have not caught up with the burgeoning field to standardize how mobile health apps are reviewed and monitored for patient safety and clinical validity. The available evidence on the safety and effectiveness of mobile health apps, especially for diabetes, remains limited. The European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) have therefore conducted a joint review of the current landscape of available diabetes digital health technology (only stand-alone diabetes apps, as opposed to those that are integral to a regulated medical device, such as insulin pumps, continuous glucose monitoring systems, and automated insulin delivery systems) and practices of regulatory authorities and organizations. We found that, across the U.S. and Europe, mobile apps intended to manage health and wellness are largely unregulated unless they meet the definition of medical devices for therapeutic and/or diagnostic purposes. International organizations, including the International Medical Device Regulators Forum and the World Health Organization, have made strides in classifying different types of digital health technology and integrating digital health technology into the field of medical devices. As the diabetes digital health field continues to develop and become more fully integrated into everyday life, we wish to ensure that it is based on the best evidence for safety and efficacy. As a result, we bring to light several issues that the diabetes community, including regulatory authorities, policy makers, professional organizations, researchers, people with diabetes, and health care professionals, needs to address to ensure that diabetes health technology can meet its full potential. These issues range from inadequate evidence on app accuracy and clinical validity to lack of training provision, poor interoperability and standardization, and insufficient data security. We conclude with a series of recommended actions to resolve some of these shortcomings.