On Friday, the FDA issued a warning to patients and providers describing the dangers of diabetes management devices and software that haven’t been assessed by the agency. These include any unapproved or unauthorized continuous glucose monitors, insulin pumps and automated insulin dosing systems, whether used as a standalone device or integrated as part of a glucose management system.
“These unauthorized diabetes management devices have not been reviewed by the FDA to ensure they provide a reasonable assurance of safety and effectiveness for their intended use,” the agency wrote in Friday’s safety communication. “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 advisory appears to have been prompted by the report of a serious adverse event, as well as the identification of unnamed manufacturers marketing devices that have not been cleared by the health regulator.
The former case involved a patient who had combined an authorized glucose sensor with an unauthorized receiver device, algorithm for calculating glucose values and automated insulin dosing device, according to the warning. This patient’s improvised management system led to an overdose of insulin that required a 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 agency wrote. “Based on the available information, it is unclear whether the insulin overdose resulted from inaccurate glucose values reported from the unauthorized sensor, or a software malfunction in the unauthorized automated insulin dosing system that misinterpreted the electronic signal from the unauthorized continuous glucose monitoring system.”
As for the unauthorized marketing, the FDA cited diabetes management devices using an unvetted algorithm that translates raw data from a cleared glucose sensor into a displayed glucose level.
“The FDA has not evaluated the algorithm that these unauthorized devices use. The algorithm may return inaccurate glucose values,” the agency wrote.
WHY IT MATTERS
There is an active DIY movement comprised of consumers looking to either build their own glucose management devices, or to combine assorted manufacturers’ devices into a homebrew artificial pancreas. While some of these efforts have earned the blessings of research groups, or have been headed by health researchers themselves, the FDA still wants consumers and health care professionals to understand the serious risk of improper dosing that come from using untested technologies.
“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 US. 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,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “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.”
WHAT’S THE TREND
The FDA has come a long way since clearing its first closed-loop insulin delivery system back in 2016 in its effort to provide diabetes patients with secure options for diabetes management. The past couple of years have seen clearances for a handful of CGMs, connected insulin pumps and dosing systems, among the most recent of which was De Novo clearance for Tandem Diabetes Care’s interoperable insulin pump.