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

Kenneth D. Mandl, Marion McNabb, Norman Marks, Elissa R. Weitzman, Skyler Kelemen, Emma M. Eggleston, Maryanne Quinn

Research output: Contribution to journalArticle

Abstract

Background and 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 fingerstick 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. Discussion: 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 reachback 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.

Original languageEnglish (US)
Pages (from-to)687-691
Number of pages5
JournalJournal of the American Medical Informatics Association
Volume21
Issue number4
DOIs
StatePublished - 2014
Externally publishedYes

Fingerprint

Equipment Safety
Social Media
Equipment and Supplies
Social Support
Insulin
Public Health Surveillance
Glucose
Privacy
Hypoglycemia
Hyperglycemia
Blood Glucose
Volunteers
Communication
Population

ASJC Scopus subject areas

  • Health Informatics

Cite this

Participatory surveillance of diabetes device safety : A social media-based complement to traditional FDA reporting. / Mandl, Kenneth D.; McNabb, Marion; Marks, Norman; Weitzman, Elissa R.; Kelemen, Skyler; Eggleston, Emma M.; Quinn, Maryanne.

In: Journal of the American Medical Informatics Association, Vol. 21, No. 4, 2014, p. 687-691.

Research output: Contribution to journalArticle

Mandl, Kenneth D. ; McNabb, Marion ; Marks, Norman ; Weitzman, Elissa R. ; Kelemen, Skyler ; Eggleston, Emma M. ; Quinn, Maryanne. / Participatory surveillance of diabetes device safety : A social media-based complement to traditional FDA reporting. In: Journal of the American Medical Informatics Association. 2014 ; Vol. 21, No. 4. pp. 687-691.
@article{4fae96d2c65643359cb32c9c9cbfd1e8,
title = "Participatory surveillance of diabetes device safety: A social media-based complement to traditional FDA reporting",
abstract = "Background and 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 fingerstick 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. Discussion: 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 reachback 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.",
author = "Mandl, {Kenneth D.} and Marion McNabb and Norman Marks and Weitzman, {Elissa R.} and Skyler Kelemen and Eggleston, {Emma M.} and Maryanne Quinn",
year = "2014",
doi = "10.1136/amiajnl-2013-002127",
language = "English (US)",
volume = "21",
pages = "687--691",
journal = "Journal of the American Medical Informatics Association : JAMIA",
issn = "1067-5027",
publisher = "Oxford University Press",
number = "4",

}

TY - JOUR

T1 - Participatory surveillance of diabetes device safety

T2 - A social media-based complement to traditional FDA reporting

AU - Mandl, Kenneth D.

AU - McNabb, Marion

AU - Marks, Norman

AU - Weitzman, Elissa R.

AU - Kelemen, Skyler

AU - Eggleston, Emma M.

AU - Quinn, Maryanne

PY - 2014

Y1 - 2014

N2 - Background and 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 fingerstick 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. Discussion: 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 reachback 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.

AB - Background and 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 fingerstick 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. Discussion: 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 reachback 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.

UR - http://www.scopus.com/inward/record.url?scp=84902381460&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84902381460&partnerID=8YFLogxK

U2 - 10.1136/amiajnl-2013-002127

DO - 10.1136/amiajnl-2013-002127

M3 - Article

C2 - 24355131

AN - SCOPUS:84902381460

VL - 21

SP - 687

EP - 691

JO - Journal of the American Medical Informatics Association : JAMIA

JF - Journal of the American Medical Informatics Association : JAMIA

SN - 1067-5027

IS - 4

ER -