ArticleJournal of diabetes science and technology2024
Insulin Pump-Associated Adverse Events in a Brazilian Reference Center for the Treatment of Diabetes Mellitus: Proposal for a Taxonomy of Device Failures in Adults, Adolescents, and Children.
Article in Journal of diabetes science and technology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed, 6 citations in OpenAlex.
- Insulin infusion sets associated with adverse events: strategies for improved diabetes education.Frontiers in medicine · 2023Article
Corrections and comments
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Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSince the introduction of continuous subcutaneous insulin infusion (CSII), the benefits have been numerous. However, adverse events (AEs) are experienced by up to 40% of users per year, exposing them to potentially fatal risks. The available evidence on the variables that trigger AEs associated with CSII remains limited, indicating the importance of studies on the subject.
aimTo propose a taxonomy based on the prevalent AEs experienced by patients from a reference diabetes mellitus (DM) center in Brazil using different CSII devices.
methods118 patients participated in an online interview and answered the questions of the data collection instrument. Identifying categories and subcategories of analysis contributed to constructing the AEs taxonomy.
resultsThe five analysis categories identified were: CSII User Interface (n = 45), CSII Alert System (n = 13), CSII Software and Connection (n = 11), CSII Durability (n = 30), and Electrical and Mechanical System of CSII (n = 60) A total of 159 AEs were identified, including conflicting alert messages and error/warning notification failures, errors resulting from engine malfunctions, data loss, patient interface deficiencies, button problems, and battery failure.
conclusionsThe study describes in a taxonomic format the AEs directly associated with the use of modern CSIIs that may contribute with additional information to the Food and Drug Administration (FDA) Medical Device Report (MDR) adverse event codes. In addition to guiding educational actions in the treatment of DM and providing information for health professionals and medical device developers, prospective studies examining the frequency of such problems, including the potential psychosocial impact of this technologically advanced therapy, are needed.
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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 OpenQuestion graph.