2903-LB: Integration of CGM, ePRO, and Digital Biomarkers in Early-Phase Obesity Trials

Introduction and Objective: The integration of continuous glucose monitoring (CGM), electronic patient-reported outcomes (ePRO), and digital biomarkers offers the potential to enhance data richness and operational efficiency in early-phase obesity trials. Understanding how these technologies can be deployed effectively is critical to improving trial design, patient engagement, and endpoint measurement. Methods: Structured interviews were conducted with scientific, medical, and operational professionals involved in early-phase obesity trials. Discussions focused on experiences with CGM, ePRO, and other digital biomarkers, including their impact on trial execution, patient adherence, data quality, and operational workflow. Qualitative analysis was performed to identify key benefits, challenges, and best practices for implementing these tools in early-phase programs. Results: CGM enabled detailed metabolic profiling and dynamic assessment of treatment effects, while ePRO and digital biomarkers improved patient engagement and captured functional outcomes in real time. Operational benefits included reduced site burden and more frequent, high-quality data collection, but challenges included technology adoption, data integration across platforms, and patient training requirements. Successful implementation relied on early planning, alignment of digital tools with trial endpoints, and continuous monitoring of adherence and data quality. Overall, digital integration was perceived as feasible and beneficial when supported by dedicated operational infrastructure and cross-functional collaboration. Conclusion: The integration of CGM, ePRO, and digital biomarkers in early-phase obesity trials can enhance endpoint assessment and operational efficiency. Structured insights from multidisciplinary professionals underscore the importance of careful technology selection, proactive patient support, and robust data management strategies to maximize the value of digital tools in clinical development. Disclosure P. Sandroni: None.