Diabetes technology

Analysis of Adverse Events in Medical Devices for Diabetes

J Diabetes Sci TechnolPublished Descriptive analysis of technovigilance (adverse event) databases

Authors' conclusion

This paper highlights the need to encourage the practice of reporting to generate evidence and to present strategies to mitigate adverse events, such as developing user-centered technologies inserted in an interdisciplinary ecosystem in the form of a living laboratory; considering accessibility aspects in development and incorporation; developing guidance resources for users; considering metrological aspects to ensure technological reliability; and including sustainability, security, and data privacy actions. Interconnectivity opens up opportunities for the ubiquitous management of technological processes throughout the life cycle.

Study context

Population
Adverse event notifications for home-use diabetes devices (blood glucose monitor (BGM), CGM, insulin pump)
Comparison
BGM vs CGM vs Insulin Pump
Outcome
Notifications on MAUDE-FDA
Follow-up
January 2019–December 2024
Methodological detailsANVISA Technovigilance Analytical Portal (Brazil) and MAUDE-FDA (USA), January 2019–December 2024
  • ANVISA Technovigilance Analytical Portal (Brazil) and MAUDE-FDA (USA)
  • January 2019–December 2024

Main finding

As reported in the abstract

BGM

52,601

events

CGM

1,624,664

events

Insulin Pump

1,339,652

events

Further findings

Mitigation strategies

Strategies to mitigate adverse events presented, related to human, technological and environmental factors

Safety

Main problems reported with the patient were hypoglycemia and hyperglycemia

Original publication

Analysis of Adverse Events in Medical Devices for Diabetes. J Diabetes Sci Technol. Published 15 September 2025. doi:10.1177/19322968251368860

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