Participatory surveillance of diabetes device safety: a social media-based complement to traditional FDA reporting

Journal of the American Medical Informatics Association : JAMIA
Kenneth D MandlMaryanne Quinn

Abstract

Malfunctions or poor usability of devices measuring glucose or delivering insulin are reportable to the FDA. Manufacturers submit 99.9% of these reports. We test online social networks as a complementary source to traditional FDA reporting of device-related adverse events. Participatory surveillance of members of a non-profit online social network, TuDiabetes.org, from October 2011 to September 2012. Subjects were volunteers from a group within TuDiabetes, actively engaged online in participatory surveillance. They used the free TuAnalyze app, a privacy-preserving method to report detailed clinical information, available through the network. Network members were polled about finger-stick blood glucose monitors, continuous glucose monitors, and insulin delivery devices, including insulin pumps and insulin pens. Of 549 participants, 75 reported device-related adverse events, nearly half (48.0%) requiring intervention from another person to manage the event. Only three (4.0%) of these were reported by participants to the FDA. All TuAnalyze reports contained outcome information compared with 22% of reports to the FDA. Hypoglycemia and hyperglycemia were experienced by 48.0% and 49.3% of participants, respectively. Members of an onl...Continue Reading

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Jun 27, 2012·Journal of the American Medical Informatics Association : JAMIA·Marc D NatterKenneth D Mandl
Feb 13, 2013·JAMA Internal Medicine·Elissa R WeitzmanKenneth D Mandl

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Citations

Jun 24, 2016·Circulation·John S RumsfeldUNKNOWN American Heart Association Emergency Cardiovascular Care Committee; Council on Cardiopulmonary, Critical Care, Perioperative
Dec 26, 2018·Journal of Diabetes Science and Technology·Jan S Krouwer
Mar 5, 2021·Medical Devices : Evidence and Research·Josep PaneMiriam C J M Sturkenboom

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