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This study examines the real experience of using continuous glucose monitors (MCG) for diabetes mellitus, focusing on the post-commercialization surveillance of these devices. Continuous glucose monitors represent a crucial tool in the management of diabetes, offering real-time monitoring and glucose trends to inform treatment decisions. Despite technological advances and the approval of devices by regulatory entities, such as the Food and Drug Administration (FDA), a notable lack of real-use data that evidence their long-term impact on diabetes management persists. This analysis uses reports collected from the FDA Manufacturer and User Facility Device Experience (MAUDE) platform from 2018 to 2023 to highlight trends in the distribution of adverse events and to classify the problems reported according to the type of device and the nature of the problem. The results underline the importance of continuous surveillance and adaptation in both MCG technology and diabetes management strategies to maximize the benefits of these devices in the quality of life of patients. This work highlights the need for transparent and updated report platforms for efficient collaboration among manufacturers, regulators, health professionals, and patients, seeking to continually improve patient care and device safety.

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Real-World Experience of Continuous Glucose Monitors for Diabetes Mellitus: Post-marketing Surveillance

  • 会议论文

  • 发表日期：

    2025年

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  • Cristina Orihuela-Flores,
  • Javier Cóndor-Sánchez,
  • Maria C. Soto-Casasola,
  • Julissa E. Venancio-Huerta

摘要

This study examines the real experience of using continuous glucose monitors (MCG) for diabetes mellitus, focusing on the post-commercialization surveillance of these devices. Continuous glucose monitors represent a crucial tool in the management of diabetes, offering real-time monitoring and glucose trends to inform treatment decisions. Despite technological advances and the approval of devices by regulatory entities, such as the Food and Drug Administration (FDA), a notable lack of real-use data that evidence their long-term impact on diabetes management persists. This analysis uses reports collected from the FDA Manufacturer and User Facility Device Experience (MAUDE) platform from 2018 to 2023 to highlight trends in the distribution of adverse events and to classify the problems reported according to the type of device and the nature of the problem. The results underline the importance of continuous surveillance and adaptation in both MCG technology and diabetes management strategies to maximize the benefits of these devices in the quality of life of patients. This work highlights the need for transparent and updated report platforms for efficient collaboration among manufacturers, regulators, health professionals, and patients, seeking to continually improve patient care and device safety.