FDA Warns Against the Use of Unauthorized Devices for Diabetes Management following Serious Adverse Patient Event

Diabetes Ireland does not want to see a similar event here and urges anyone using or considering using Diabetes DIY technology to speak to and consult with their diabetes team.


Following a report of a serious adverse event in which a patient’s use of an illegally marketed continuous glucose monitoring system along with an unauthorized automated insulin dosing system resulted in insulin overdose requiring medical attention, the U.S. Food and Drug Administration (FDA) is warning patients and health care professionals of risks associated with the use of unapproved or unauthorized devices for diabetes management, including continuous glucose monitoring systems, insulin pumps and automated insulin dosing systems. The FDA noted that the use of unapproved or unauthorized devices could result in inaccurate blood glucose (sugar) measurements or unsafe insulin dosing, which can lead to injury requiring medical intervention or even death.


Diabetes Ireland understands that there are a small number of people with Type 1 diabetes in the Republic of Ireland using closed-loop systems based on “do-it-yourself” (“DIY”) technology to help manage their condition.  These technologies are not commercially available and are ‘built’ by individuals with diabetes for their own use. They have not been approved for use by regulatory bodies as they have not undergone the required patient safety studies and people use them at their own risk.


Dr Anna Clarke, Health Promotion & Research Manager, Diabetes Ireland said “Diabetes Ireland respects the rights of individual people with type 1 diabetes to choose how they manage their condition and to avail of treatments they believe best fit their needs.   However, Diabetes Ireland has concerns about the use and safety of Diabetes DIY tech systems as these products are not regulated or approved and their use may carry serious risks to those using them. Diabetes Ireland does not endorse these DIY technologies; as they are not approved technologies and are highly experimental.


Any person using a Diabetes DIY technology solution does so at their own risk.  In addition, the organisation recognises that for healthcare professionals caring for people with type 1 diabetes, the emergence of unapproved DIY diabetes technologies poses concerns including medico-legal risks which require further consideration and guidance for those working in the Republic of Ireland.


“Following on from the reported patient adverse event, Diabetes Ireland urges anyone using or considering using Diabetes DIY technology to speak to and consult with their diabetes team about its use” Dr Clarke.


See full FDA article – https://www.fda.gov/news-events/press-announcements/fda-warns-against-use-unauthorized-devices-diabetes-management