Today, the 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. In the safety communication issued today, the agency 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.
“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. 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,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Today’s warning is part of our ongoing public health commitment to protect patients and communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices.”
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.
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. Patient use of unauthorized diabetes management devices, alone or in conjunction with other devices, could result in inaccurate glucose level readings 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 blood) and death.