U.S. Food and Drug Administration 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.
There are many types of devices that patients use to manage diabetes. A continuous glucose monitoring system uses a sensor and transmitter to continuously track a patient’s glucose levels at all times. An insulin pump is a small computerized device that delivers insulin through a catheter (a small, flexible tube) placed under a person’s skin throughout the day. An automated insulin dosing system is a system that is intended to automatically deliver insulin doses based on glucose measurements from a continuous glucose monitoring system. Some of these diabetes management devices may be reviewed by the FDA as a whole system or they may be reviewed to be compatible with other FDA authorized components, such as integrated continuous glucose monitoring systems. This is known as interoperability, which allows patients to safely tailor their diabetes management to their individual preferences by choosing devices that are authorized by the FDA to work together.
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 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. The agency is concerned that patients may not fully be aware of the risks of using components or systems not reviewed by the FDA. The agency has received 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 FDA recommends that patients talk with their doctor about appropriate diabetes management devices for their needs and to only use devices and components that have been reviewed by the agency for safety and effectiveness. 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.
As part of this critical work, the FDA will continue to closely monitor reports of adverse events associated with the use of unauthorized devices for diabetes management and will keep the public informed if new information becomes available.
