The U.S. Food and Drug Administration (FDA) has issued a warning about the use of unapproved devices for diabetes management, so-called “DIY” diabetes management devices that include continuous glucose monitoring systems, insulin pumps, and automated insulin dosing systems.
The agency noted that the use of unapproved or unauthorized devices could result in inaccurate blood glucose measurements or unsafe insulin dosing, which can lead to risks requiring medical intervention, such as severe low blood sugar, coma, diabetic ketoacidosis (buildup of acids in the blood) and death.
According to Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, millions of Americans use continuous glucose monitors and insulin delivery devices to monitor and treat their diabetes.
“Because of the complexity of these devices and the life-saving care they provide, it’s important that patients are aware of the risks that arise when they’re not used as intended or when they use devices not authorized for sale in the U.S.,” Shuren said in a statement. “By using products that have not been reviewed by the agency for safety and effectiveness, patients with diabetes may be putting themselves at risk for serious injury or even death.”
Shuren says the FDA’s warning is part of their ongoing public health commitment to protect patients and communicate with the public when they become aware of issues stemming from the use, or misuse, of medical devices.
The FDA is aware of manufacturers illegally marketing unauthorized devices for diabetes management, which have not been reviewed by the agency for safety and effectiveness.
Companies are also illegally marketing components, such as unauthorized continuous glucose monitors that some patients may integrate into unauthorized automated insulin dosing systems.
Additionally, the FDA is aware of patients combining devices or components that are not intended for use with other devices.
The FDA warns that when devices that are not intended for use with other devices are combined or when unauthorized devices are used, new risks are introduced that have not been properly evaluated by the FDA for safety.
The FDA is aware that patients may choose to create these systems or purchase unauthorized or unapproved components or systems because of personal preference or for cost reasons.
Patients who are concerned about the cost or availability of FDA-reviewed systems should talk with their doctor and insurance provider about coverage and appropriate alternative options.
- U.S. Food and Drug Administration. FDA Warns Against the Use of Unauthorized Devices for Diabetes Management. (May 17, 2019). Retrieved: https://www.fda.gov/news-events/press-announcements/fda-warns-against-use-unauthorized-devices-diabetes-management