Privacy-Preserving Glycemic Management in Type 1 Diabetes: Development and Validation of a Multiobjective Federated Reinforcement Learning Framework

Background: Effective diabetes management requires precise glycemic control to prevent both hypoglycemia and hyperglycemia, yet existing machine learning (ML) and reinforcement learning (RL) approaches often fail to balance competing objectives. Traditional RL-based glucose regulation systems primarily focus on single-objective optimization, overlooking factors such as minimizing insulin overuse, reducing glycemic variability, and ensuring patient safety. Furthermore, these approaches typically rely on centralized data processing, which raises privacy concerns due to the sensitive nature of health care data. There is a critical need for a decentralized, privacy-preserving framework that can personalize blood glucose regulation while addressing the multiobjective nature of diabetes management. Objective: This study aimed to develop and validate PRIMO-FRL (Privacy-Preserving Reinforcement Learning for Individualized Multi-Objective Glycemic Management Using Federated Reinforcement Learning), a novel framework that optimizes clinical objectives-maximizing time in range (TIR), reducing hypoglycemia and hyperglycemia, and minimizing glycemic risk-while preserving patient privacy. Methods: We developed PRIMO-FRL, integrating multiobjective reward shaping to dynamically balance glucose stability, insulin efficiency, and risk reduction. The model was trained and tested using simulated data from 30 simulated patients (10 children, 10 adolescents, and 10 adults) generated with the Food and Drug Administration (FDA)-approved UVA/Padova simulator. A comparative analysis was conducted against state-of-the-art RL and ML models, evaluating performance using metrics such as TIR, hypoglycemia (<70 mg/dL), hyperglycemia (>180 mg/dL), and glycemic risk scores. Results: The PRIMO-FRL model achieved a robust overall TIR of 76.54%, with adults demonstrating the highest TIR at 81.48%, followed by children at 77.78% and adolescents at 70.37%. Importantly, the approach eliminated hypoglycemia, with 0.0% spent below 70 mg/dL across all cohorts, significantly outperforming existing methods. Mild hyperglycemia (180-250 mg/dL) was observed in adolescents (29.63%), children (22.22%), and adults (18.52%), with adults exhibiting the best control. Furthermore, the PRIMO-FRL approach consistently reduced glycemic risk scores, demonstrating improved safety and long-term stability in glucose regulation.. Conclusions: Our findings highlight the potential of PRIMO-FRL as a transformative, privacy-preserving approach to personalized glycemic management. By integrating federated RL, this framework eliminates hypoglycemia, improves TIR, and preserves data privacy by decentralizing model training. Unlike traditional centralized approaches that require sharing sensitive health data, PRIMO-FRL leverages federated learning to keep patient data local, significantly reducing privacy risks while enabling adaptive and personalized glucose control. This multiobjective optimization strategy offers a scalable, secure, and clinically viable solution for real-world diabetes care. The ability to train personalized models across diverse populations without exposing raw data makes PRIMO-FRL well-suited for deployment in privacy-sensitive health care environments. These results pave the way for future clinical adoption, demonstrating the potential of privacy-preserving artificial intelligence in optimizing glycemic regulation while maintaining security, adaptability, and personalization.

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