ArticleJournal of diabetes science and technology2025
Analysis of Adverse Events in Medical Devices for Diabetes.
Article in Journal of diabetes science and technology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe objective of this study is to identify adverse events involving medical devices used in home environments with a focus on patients with diabetes and to categorize the probable causes.
methodsThe chosen technologies that are fundamental for monitoring blood glucose and used in users' decision-making were: blood glucose monitor (BGM), continuous glucose monitoring system (CGM) and Insulin Pump. In the search for evidence, two databases from the collection of technovigilance alerts between January 2019 and December 2024 were used: the Technovigilance Analytical Portal of the National Health Surveillance Agency (ANVISA) of Brazil and MAUDE-FDA-USA.
resultsOn the MAUDE-FDA platform, the total number of notifications were: 52,601 BGM, 1,624,664 of CGM, and 1,339,652 Insulin Pump. Strategies to mitigate the occurrence of adverse events were presented, related to human, technological, and environmental factors. Regarding the main problems reported with the patient, they were hypoglycemia and hyperglycemia.
conclusionThis 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.