The FDA on Friday issued a warning for people with diabetes and their health care providers cautioning against the use of diabetes management devices that have not been fully evaluated and are not yet available for purchase in the United States.
With a focus on unauthorized continuous glucose monitoring systems, insulin pumps and automated insulin dosing systems, as well as the use of these unauthorized devices in combination with those that have received approval, the FDA noted that users could potentially suffer due to improper insulin doses and faulty glucose level measures.
The warning was the result of a report in which an individual with diabetes experienced an adverse medical reaction to an unauthorized device and algorithm used in combination with a glucose sensor that was approved by the FDA. This instance highlighted the potential complications from use of unauthorized devices, specifically when used with other devices, whether they be authorized or not.
“When patients combine devices that are not intended for use with other devices, or when patients use any unauthorized devices, new risks are introduced that the FDA has not evaluated for safety or effectiveness,” the FDA statement said. Diabetic ketoacidosis, low blood sugar, coma and death are all potentially dangerous outcomes associated with use of these devices, according to the release.
Using a combination of devices is common and with previously approved integrated continuous glucose monitoring systems, an interoperable insulin pump and “automated controlled enabled” insulin pumps, the FDA stated that options exist for a more personalized diabetes treatment strategy.
The statement emphasized that health care providers should work with their patients with diabetes to emphasize the correct use of approved devices and warn them of the potential dangers of using unauthorized options.
The FDA will continue to track adverse event reports associated with diabetes management devices.