Carlson Anders L, Badlani Sameer, Shah Viral N
International Diabetes Center, Minneapolis, Minnesota.
Digital and Technology, Fairview Health Services, Minneapolis - St Paul, Minnesota; Heinz College, Carnegie Mellon, Pittsburgh, Pennsylvania.
Clin Ther. 2025 Aug;47(8):638-648. doi: 10.1016/j.clinthera.2025.05.002. Epub 2025 Jun 9.
Health and financial burdens associated with poorly managed diabetes are considerable both for individuals and for healthcare systems. The last decade has seen a significant increase in the use of automated insulin delivery systems, continuous glucose monitoring and insulin pumps. With this, digital healthcare tools - such as smart or connected insulin pens and wearable continuous glucose monitoring (CGM) sensors utilizing current digital smartphone and wireless technology have emerged - helping people with diabetes and their healthcare providers maximize treatment adherence and achieve optimal glycemic control. This article reviews the available literature to assess current unmet needs within diabetes care management, summarizes the efficacy and safety of the latest US Food and Drug Administration (FDA)-approved insulin delivery systems and digital diabetes healthcare tools, and investigate the economic and healthcare benefits of such FDA-approved digital healthcare tools for people with diabetes in the US.
Literature searches were conducted using PubMed for articles published between 2014 and 2023. Type of articles included were narrative reviews, systematic reviews, randomized controlled trials and cost-effectiveness analyses.
There are many insulin delivery systems and associated digital devices, CGMs and software applications that utilize wireless and smartphone technology available within the US that have published efficacy, safety and cost-benefit outcomes. The safety and efficacy of CGM and continuous subcutaneous insulin infusion (CSII) therapy are well established. In contrast, the evidence available for the most recent digital diabetes healthcare tools (e.g., smart or connected insulin pens) is relatively limited.
Despite the acknowledged cost-effectiveness of digital healthcare tools within diabetes care and potential associated cost savings for healthcare markets, there are limited numbers of clinical studies investigating the efficacy and safety of newer devices such as smart or connected insulin pens. Further research is needed to pave the way for integrating these devices more fully into diabetes management.
糖尿病管理不善给个人和医疗系统带来的健康和经济负担都相当大。在过去十年中，自动胰岛素输送系统、持续血糖监测和胰岛素泵的使用显著增加。与此同时，数字医疗工具应运而生，例如利用当前数字智能手机和无线技术的智能或联网胰岛素笔以及可穿戴式持续血糖监测（CGM）传感器，帮助糖尿病患者及其医疗服务提供者最大限度地提高治疗依从性并实现最佳血糖控制。本文回顾现有文献，以评估糖尿病护理管理中当前未满足的需求，总结美国食品药品监督管理局（FDA）最新批准的胰岛素输送系统和数字糖尿病医疗工具的疗效和安全性，并调查此类FDA批准的数字医疗工具对美国糖尿病患者的经济和医疗益处。
使用PubMed对2014年至2023年发表的文章进行文献检索。纳入的文章类型包括叙述性综述、系统综述、随机对照试验和成本效益分析。
在美国，有许多利用无线和智能手机技术的胰岛素输送系统及相关数字设备、CGM和软件应用程序，它们已发表了疗效、安全性和成本效益结果。CGM和持续皮下胰岛素输注（CSII）疗法的安全性和疗效已得到充分证实。相比之下，关于最新数字糖尿病医疗工具（如智能或联网胰岛素笔）的现有证据相对有限。
尽管数字医疗工具在糖尿病护理中的成本效益已得到认可，且可能为医疗市场节省相关成本，但研究新型设备（如智能或联网胰岛素笔）疗效和安全性的临床研究数量有限。需要进一步研究，为将这些设备更全面地整合到糖尿病管理中铺平道路。
