Regulatory perspectives and digital integration in diabetes management: advancing personalized medical devices and insulin therapies in the era of industry 5.0

The integration of medical devices and digital technologies has transformed diabetes management, enabling precision-based insulin delivery and continuous metabolic monitoring. This review presents a comprehensive assessment of recent advances in diabetes-focused medical devices, regulatory frameworks, and digital convergence within the paradigm of Industry 5.0. The discussion encompasses the pathophysiological basis of diabetes mellitus, emphasizing how glucose dysregulation and insulin resistance inform device design and algorithmic control strategies. Contemporary devices—such as continuous glucose monitors, insulin pumps, and closed-loop artificial pancreas systems—are critically evaluated alongside smart insulin pens and implantable sensors. Global regulatory perspectives from the United States Food and Drug Administration (USFDA) and Central Drugs Standard Control Organization (CDSCO, India) are examined with respect to device classification, premarket evaluation, and post-market surveillance. The paper also highlights emerging digital health frameworks, AI-based decision support, interoperability standards, and cybersecurity considerations that underpin human-centric, data-driven care in the Industry 5.0 era. Ethical, legal, and socioeconomic challenges surrounding data privacy and equitable access are discussed. Finally, key future perspectives are outlined to guide innovation, regulatory harmonization, and the sustainable deployment of smart diabetes devices. This synthesis aims to bridge technological advancement with patient-centered regulatory science to advance personalized and safe diabetes management worldwide.