{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T19:01:14Z","timestamp":1790017274468,"version":"4.0.1"},"reference-count":18,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2012,9,1]],"date-time":"2012-09-01T00:00:00Z","timestamp":1346457600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Diabetes Sci Technol"],"published-print":{"date-parts":[[2012,9]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Growing technological improvements in insulin pump design have increased the use of these devices in young children. To better understand the types of infusion pump-related problems and associated adverse events in this age group, we performed a comprehensive evaluation of pump-related adverse event reports received by the U.S. Food and Drug Administration (FDA) for children ages 1\u201312 years.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>A query was conducted of FDA's Manufacturer and User Facility Device Experience database from January 1, 1996, through December 31, 2009, in children ages 1\u201312 years involving insulin pumps. Report narratives were individually reviewed for age, gender, and seriousness of outcomes. Device or patient problems and potential contributory factors were assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Over the past 14 years, 1774 (7%) of all insulin pump adverse event reports were identified in children ages 1\u201312. Of these reports, 777 (43%) resulted in hospitalization. In hospitalized cases ( n = 614), diabetic ketoacidosis and\/or hyperglycemia were the predominant patient problems, and in other cases ( n = 98), hypoglycemia was evident. There were 106 emergency room visits, 19 cases requiring paramedic attention, and five deaths. The majority of reports indicated that the devices were not returned to the manufacturer, and root causes were not always confirmed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Younger children with diabetes deserve careful consideration of the risk and benefit of insulin pump technology. Studies are needed to better understand pediatric safety issues and to identify the root cause of adverse events. Problems related to patient education, device misuse, and malfunctions were found, highlighting the need to strengthen user training for children and their caregivers.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/193229681200600509","type":"journal-article","created":{"date-parts":[[2014,1,10]],"date-time":"2014-01-10T10:35:52Z","timestamp":1389350152000},"page":"1053-1059","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":28,"title":["Pediatric Use of Insulin Pump Technology: A Retrospective Study of Adverse Events in Children Ages 1\u201312 Years"],"prefix":"10.1177","volume":"6","author":[{"given":"Judith U.","family":"Cope","sequence":"first","affiliation":[{"name":"Office of Pediatric Therapeutics, Office of Special Medical Programs, Office of the Commissioner, Food and Drug Administration, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joy H.","family":"Samuels-Reid","sequence":"additional","affiliation":[{"name":"Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Audrey E.","family":"Morrison","sequence":"additional","affiliation":[{"name":"Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2012,9,1]]},"reference":[{"key":"bibr1-193229681200600509","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2007-1707"},{"key":"bibr2-193229681200600509","doi-asserted-by":"publisher","DOI":"10.2337\/dc09-0889"},{"key":"bibr3-193229681200600509","unstructured":"How to Report a Problem (Medical Devices). U.S. Food and Drug Administration. http:\/\/www.fda.gov\/MedicalDevices\/Safety\/ReportaProblem\/default.htm. Accessed February 29, 2012."},{"key":"bibr4-193229681200600509","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3476(94)70190-3"},{"key":"bibr5-193229681200600509","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2008-1415"},{"key":"bibr6-193229681200600509","doi-asserted-by":"publisher","DOI":"10.1016\/j.pedhc.2008.07.002"},{"key":"bibr7-193229681200600509","doi-asserted-by":"publisher","DOI":"10.1097\/MED.0b013e32825a675e"},{"key":"bibr8-193229681200600509","doi-asserted-by":"publisher","DOI":"10.1111\/j.1399-5448.2010.00701.x"},{"key":"bibr9-193229681200600509","doi-asserted-by":"publisher","DOI":"10.1159\/000129673"},{"key":"bibr10-193229681200600509","first-page":"B40","volume":"22","author":"Sovik O","year":"1999","journal-title":"Diabetes Care"},{"key":"bibr11-193229681200600509","doi-asserted-by":"publisher","DOI":"10.1177\/193229681000400232"},{"key":"bibr12-193229681200600509","doi-asserted-by":"publisher","DOI":"10.1177\/193229681000400207"},{"key":"bibr13-193229681200600509","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2009.0182"},{"key":"bibr14-193229681200600509","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2009.0161"},{"key":"bibr15-193229681200600509","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2007.0214"},{"key":"bibr16-193229681200600509","doi-asserted-by":"publisher","DOI":"10.2337\/dc06-1141"},{"key":"bibr17-193229681200600509","unstructured":"MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The U.S. Food and Drug Administration. http:\/\/www.fda.gov\/Safety\/MedWatch\/default.htm. Accessed February 29, 2012."},{"key":"bibr18-193229681200600509","unstructured":"Draft Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions. http:\/\/www.fda.gov\/medicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/ucm206153.htm. Accessed August 1, 2012."}],"container-title":["Journal of Diabetes Science and Technology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/193229681200600509","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/193229681200600509","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T18:15:08Z","timestamp":1777400108000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/193229681200600509"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012,9]]},"references-count":18,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2012,9]]}},"alternative-id":["10.1177\/193229681200600509"],"URL":"https:\/\/doi.org\/10.1177\/193229681200600509","relation":{},"ISSN":["1932-2968","1932-2968"],"issn-type":[{"value":"1932-2968","type":"print"},{"value":"1932-2968","type":"electronic"}],"subject":[],"published":{"date-parts":[[2012,9]]}}}