{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T13:46:59Z","timestamp":1777556819824,"version":"3.51.4"},"reference-count":18,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2022,6,30]],"date-time":"2022-06-30T00:00:00Z","timestamp":1656547200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/501100002322","name":"coordenacao de aperfeicoamento de pessoal de nivel superior","doi-asserted-by":"publisher","award":["CAPES, Finance Code 001"],"award-info":[{"award-number":["CAPES, Finance Code 001"]}],"id":[{"id":"10.13039\/501100002322","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Foundation of the State of Sao Paulo","award":["FAPESP n 2018\/22094-0"],"award-info":[{"award-number":["FAPESP n 2018\/22094-0"]}]},{"DOI":"10.13039\/501100003593","name":"conselho nacional de desenvolvimento cientifico e tecnologico","doi-asserted-by":"publisher","award":["CNPq 308721\/2020-9s"],"award-info":[{"award-number":["CNPq 308721\/2020-9s"]}],"id":[{"id":"10.13039\/501100003593","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Diabetes Sci Technol"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Since 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim:<\/jats:title>\n                    <jats:p>To propose a taxonomy based on the prevalent AEs experienced by patients from a reference diabetes mellitus (DM) center in Brazil using different CSII devices.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>118 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>The 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>The 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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/19322968221106196","type":"journal-article","created":{"date-parts":[[2022,6,30]],"date-time":"2022-06-30T09:08:28Z","timestamp":1656580108000},"page":"74-81","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":5,"title":["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"],"prefix":"10.1177","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5172-0428","authenticated-orcid":false,"given":"Ana L\u00facia Domingues","family":"Neves","sequence":"first","affiliation":[{"name":"Postgraduate Program in Translational Medicine, Department of Medicine, Paulista School of Medicine, Federal University of S\u00e3o Paulo, S\u00e3o Paulo\/SP, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luiz Eduardo Galv\u00e3o","family":"Martins","sequence":"additional","affiliation":[{"name":"Institute of Science and Technology, Federal University of S\u00e3o Paulo, S\u00e3o Paulo\/SP, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M\u00f4nica Andrade Lima","family":"Gabbay","sequence":"additional","affiliation":[{"name":"Department of Medicine, Paulista School of Medicine, Federal University of S\u00e3o Paulo, S\u00e3o Paulo\/SP, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gabriela","family":"Cavicchioli","sequence":"additional","affiliation":[{"name":"Ambulatory of Insulin Infusion Pump from the Federal University of S\u00e3o Paulo Diabetes Center, Sao Paulo\/SP, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fernanda Silva","family":"Tenorio","sequence":"additional","affiliation":[{"name":"Postgraduate Program in Translational Medicine, Department of Medicine, Paulista School of Medicine, Federal University of S\u00e3o Paulo, S\u00e3o Paulo\/SP, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9070-1414","authenticated-orcid":false,"given":"Tatiana Sousa","family":"Cunha","sequence":"additional","affiliation":[{"name":"Institute of Science and Technology, Federal University of S\u00e3o Paulo, S\u00e3o Paulo\/SP, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2022,6,30]]},"reference":[{"key":"e_1_3_3_2_2","unstructured":"International Diabetes Federation. IDF diabetes atlas. Boyko EJ Karuranga DJMS Piemonte L Saeedi PRP Sun H eds. 10th ed. Date unknown. https:\/\/diabetesatlas.org\/. Accessed June 9 2022."},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.2337\/dc09-0109"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1590\/1806-9282.60.03.010"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199309303291401."},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00125-013-3007-9"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.pcl.2015.04.005"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.2337\/dc15-0168"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00592-015-0784-2"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1177\/19322968211011688."},{"key":"e_1_3_3_11_2","unstructured":"CFR\u2014code of federal regulations title 21. Date Unknown. https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=803.3. Accessed May 17 2022."},{"key":"e_1_3_3_12_2","unstructured":"Campos ML Gomes HE. VIII ENANCIB-Encontro Nacional de Pesquisa em Ci\u00eancia da Informa\u00e7\u00e3o TAXONOMIA E CLASSIFICA\u00c7\u00c3O: a categoriza\u00e7\u00e3o como princ\u00edpio [TAXONOMY AND CLASSIFICATION: the principle of categorization]. Date unknown. http:\/\/www.enancib.ppgci.ufba.br\/artigos\/GT2\u2013101.pdf. Accessed June 9 2022."},{"key":"e_1_3_3_13_2","doi-asserted-by":"crossref","unstructured":"Plaza-Carvajal M Dutra M Macedo D. Uma proposta de taxonomia para a categoriza\u00e7\u00e3o das falhas no ambiente das cadeias de suprimentos. https:\/\/seer.ufrgs.br\/index.php\/EmQuestao\/article\/view\/71313. Published 2017. Accessed June 9 2022.","DOI":"10.19132\/1808-5245233.179-206"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2013.0192"},{"key":"e_1_3_3_15_2","unstructured":"US Food & Drug Administration. MDR adverse event codes. Date unknown. https:\/\/www.fda.gov\/medical-devices\/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities\/mdr-adverse-event-codes. Accessed May 17 2022."},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1111\/jdi.12765"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00592-016-0897-2"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.6065\/apem.2017.22.3.170"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1177\/1932296820951872"}],"container-title":["Journal of Diabetes Science and Technology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/19322968221106196","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/19322968221106196","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/19322968221106196","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T18:15:58Z","timestamp":1777400158000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/19322968221106196"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,6,30]]},"references-count":18,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2024,1]]}},"alternative-id":["10.1177\/19322968221106196"],"URL":"https:\/\/doi.org\/10.1177\/19322968221106196","relation":{},"ISSN":["1932-2968","1932-2968"],"issn-type":[{"value":"1932-2968","type":"print"},{"value":"1932-2968","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,6,30]]}}}