FDA is hoping to put the brakes on the use of unapproved or unauthorized devices for diabetes management. The federal agency is putting out a stern warning that the use of these unauthorized technologies could result in inaccurate blood glucose measurements or unsafe insulin dosing. This in turn could lead to injury requiring medical intervention or even death.
In a release, the agency said it 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. FDA said it is concerned that patients may not fully be aware of the risks of using components or systems.
The agency said it 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.
“Millions of Americans use continuous glucose monitors and insulin delivery devices to monitor and treat their diabetes,” Jeff Shuren, MD, director of FDA’s Center for Devices and Radiological Health, said in a release. “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. 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 has been an explosion in the diabetes management market in the last few years. Abbott Laboratories and Medtronic both have had landmark approvals from FDA in the market.
Dublin-based Medtronic kicked things off when it won a nod from FDA for the MiniMed 670G insulin pump, the world's first hybrid, closed-loop artificial pancreas. Nearly a year later, Abbott’s game-changing Freestyle Libre Flash was greenlit by the agency.
The approval is largely considered a major win for those with diabetes because it eliminates routine finger sticks, which have been the standard of glucose testing for more than 40 years.
In addition to approved devices there are transformational devices waiting in the wings for a nod from FDA. About a year ago, Beta Bionics received an IDE from FDA to begin a clinical trial testing the iLet Bionic Pancreas System.
Beta Bionics, which was named MD+DI Reader’s Choice for Medtech Company of the Year, is combining artificial intelligence and CGM for the iLet Bionic Pancreas System.