FDA Warns Against Unapproved Diabetes Devices

The Food and Drug Administration (FDA) is warning diabetes patients and their medical providers against using devices to help manage their illness that the agency has not reviewed or approved. Its warning covers continuous glucose monitoring systems, insulin pumps and automated insulin dosing systems.

“The FDA is concerned about people with diabetes using unauthorized devices for diabetes management used alone or along with authorized devices,” Courtney Lias, acting deputy director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, says in a statement. “The FDA advises that patients use diabetes management devices that the FDA authorized for sale in the U.S. and use them according to manufacturer instructions.”

Continuous glucose monitoring systems combine a glucose sensor inserted under the skin that tracks glucose levels through the day and night with software that translates the signal from the sensor and provides glucose levels to the patient. An insulin pump is a small computerized device that delivers insulin through a small flexible tube placed under a patient’s skin. An automated insulin dosing system is intended to automatically deliver insulin doses based on the glucose levels from a continuous glucose monitoring system.

“Use of unauthorized devices could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to injury requiring medical intervention or death,” the FDA says in its warning notice.

The FDA issued the warning because it received a report of a patient using an unauthorized automated insulin dosing device that delivered too much insulin after receiving repeated incorrect high glucose readings sent from the patient’s continuous glucose monitoring system. The patient got an overdose of insulin and required medical intervention. “These devices were not designed to be used together and were combined in a way that had not been thoroughly tested for compatibility,” the FDA notice says.

FDA officials urge patients to talk to their health care provider about how to use the various diabetes devices and/or contact the FDA at dice@fda.hhs.gov to find out whether the FDA has approved the devices they are considering using.