Unlocking Real-Time Data Access in Diabetes Management: Toward an Interoperability Model.

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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.