Randine Pietro, Kopperstad Wolff Miriam, Pocs Matthias, Connell Ian R O, Cafazzo Joseph A, Årsand Eirik
Department of Computer Science, Faculty of Science and Technology, UiT The Arctic University of Norway, Tromsø, Norway.
Department of ICT and Natural Sciences, Faculty of Natural Sciences, Norwegian University of Science and Technology, Trondheim, Norway.
J Diabetes Sci Technol. 2025 Mar 28:19322968251327602. doi: 10.1177/19322968251327602.
In today's data-driven era, openness promotes transparency and accessibility, particularly in health initiatives like the European Health Data Space. Diabetes management relies on real-time data from medical devices, such as continuous glucose monitors (CGMs), insulin pumps, and hybrid closed-loop systems. These devices provide critical insights for treatment adjustments, making real-time data access essential.
This article explores real-time data access for third-party applications, focusing on primary (treatment) and secondary (research) use. We examine how application programming interfaces (APIs) enable secure data retrieval and assess the impact of terms of service and copyright law on patient-driven innovation in open-source communities. Our research evaluates diabetes medical devices and software solutions in Norway, assessing their real-time data access and API functionalities. In addition, we analyze legal frameworks governing these technologies, focusing on challenges faced by open-source solutions. Based on our findings, we propose an interoperability model to improve data accessibility while ensuring security and transparency.
Findings reveal seven diabetes devices and nine regulated software solutions, with only one offering a publicly accessible API. This emphasizes a significant gap in real-time data access. Comparisons between vendor-specific and open-source software expose interoperability and accessibility challenges. While Do-It-Yourself (DIY) solutions foster innovation, they face technical and legal barriers.
Real-time diabetes management presents security, transparency, and access challenges. Regulatory decisions are needed to implement an interoperability model. The lack of real-time data access highlights the necessity of publicly accessible APIs that prioritize transparency, accessibility, and patient-driven innovation-marking a shift from today's constrained diabetes management landscape.
在当今数据驱动的时代，开放性促进了透明度和可及性，尤其是在欧洲健康数据空间等健康倡议中。糖尿病管理依赖于来自医疗设备的实时数据，如连续血糖监测仪（CGM）、胰岛素泵和混合闭环系统。这些设备为治疗调整提供关键见解，因此实时数据访问至关重要。
本文探讨第三方应用程序的实时数据访问，重点关注主要（治疗）和次要（研究）用途。我们研究应用程序编程接口（API）如何实现安全的数据检索，并评估服务条款和版权法对开源社区中患者驱动创新的影响。我们的研究评估了挪威的糖尿病医疗设备和软件解决方案，评估它们的实时数据访问和API功能。此外，我们分析了管理这些技术的法律框架，重点关注开源解决方案面临的挑战。基于我们的发现，我们提出了一个互操作性模型，以提高数据可及性，同时确保安全性和透明度。
研究结果揭示了七种糖尿病设备和九种受监管的软件解决方案，其中只有一种提供可公开访问的API。这凸显了实时数据访问方面的巨大差距。特定供应商软件和开源软件之间的比较揭示了互操作性和可及性方面的挑战。虽然自己动手（DIY）解决方案促进了创新，但它们面临技术和法律障碍。
实时糖尿病管理面临安全、透明度和访问方面的挑战。需要做出监管决策来实施互操作性模型。实时数据访问的缺乏凸显了公开可用API的必要性，这些API应优先考虑透明度、可及性和患者驱动的创新，这标志着从当今受限的糖尿病管理格局的转变。
