title: Participatory surveillance of diabetes device safety: a social media-based complement to traditional FDA reporting.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Members of an online community readily engaged in participatory surveillance. While polling distributed online populations does not yield generalizable, denominator-based rates, this approach can characterize risk within online communities using a bidirectional communication channel that enables reach-back and intervention.
  
  
  CONCLUSIONS
  Engagement of distributed communities in social networks is a viable complementary approach to traditional public health surveillance for adverse events related to medical devices.
authors.affiliation: Children's Hospital Informatics Program at Harvard-MIT Health Sciences and Technology, Boston Children's Hospital, Boston, Massachusetts, USA Division of Emergency Medicine, Boston Children's Hospital, Boston, Massachusetts, USA Department of Pediatrics, Center for Biomedical Informatics, Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: Kenneth D
authors.initials: KD
authors.lastname: Mandl
authors.affiliation: Department of International Health, Boston University School of Public Health, Boston, Massachusetts, USA.
authors.forename: Marion
authors.initials: M
authors.lastname: McNabb
authors.affiliation: U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: Norman
authors.initials: N
authors.lastname: Marks
authors.affiliation: Children's Hospital Informatics Program at Harvard-MIT Health Sciences and Technology, Boston Children's Hospital, Boston, Massachusetts, USA Division of Adolescent Medicine, Boston Children's Hospital, Boston, Massachusetts, USA Department of Pediatrics, Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: Elissa R
authors.initials: ER
authors.lastname: Weitzman
authors.affiliation: Children's Hospital Informatics Program at Harvard-MIT Health Sciences and Technology, Boston Children's Hospital, Boston, Massachusetts, USA.
authors.forename: Skyler
authors.initials: S
authors.lastname: Kelemen
authors.affiliation: Department of Population Medicine, Harvard Pilgrim HealthCare Institute, Harvard Medical School, Boston, Massachusetts, USA Division of Endocrinology, Brigham and Women's Hospital, Boston, Massachusetts, USA.
authors.forename: Emma M
authors.initials: EM
authors.lastname: Eggleston
authors.affiliation: Department of Pediatrics, Harvard Medical School, Boston, Massachusetts, USA Division of Endocrinology, Boston Children's Hospital, Boston, Massachusetts, USA.
authors.forename: Maryanne
authors.initials: M
authors.lastname: Quinn
mesh_terms: D015190:Blood Glucose Self-Monitoring / Q000009:adverse effects / Q000295:instrumentation*; D003625:Data Collection; D003920:Diabetes Mellitus / Q000188:drug therapy*; D004868:Equipment Failure; D004869:Equipment Safety; D006801:Humans; D007332:Insulin Infusion Systems / Q000009:adverse effects* / Q000592:standards; D020407:Internet; D011358:Product Surveillance, Postmarketing; D060756:Social Networking; D014481:United States; D014486:United States Food and Drug Administration
keywords: medical device; social networking; surveillance