The US Food and Drug Administration (FDA) issued a safety communication Friday to warn about adverse event risks in patients’ use of diabetes management devices lacking approvals or clearances.
The safety communication raises the agency’s concerns about whether patients are fully aware of the risks of adverse events when using continuous glucose monitoring systems, insulin pumps and automated insulin dosing systems or components that have not undergone FDA review. FDA explains that while it may conduct a review of a whole system, it may also review components designed to be compatible with previously authorized components. The latter is known as the interoperability that allows for care plans tailored by patients.
At the center of the concerns lies a trend, known as the do-it-yourself (DIY) approach, among diabetics, in which patients create their own systems by combining various devices based on personal preferences or to save on costs. Using components or systems not reviewed by FDA, or authorized devices not evaluated for use in conjunction with other devices can result in inaccurate glucose level readings or unsafe insulin dosing.
“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,” says
FDA Center for Devices and Radiological Health Director Jeffrey Shuren. “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.”
FDA points to a reported adverse event in which a patient used an unauthorized automated insulin dosing system, resulting in an insulin overdose requiring medical intervention. The unauthorized automated insulin dosing system had delivered too much insulin to the patient after repeatedly sending incorrect high glucose values from an unauthorized continuous glucose monitoring system. The glucose sensor of the unauthorized continuous glucose monitoring system had been FDA authorized, but the algorithm that the glucose sensor uses to convert an electronic signal to a glucose value had not. Yet whether the hypoglycemic event resulted from the sensor’s values or a software malfunction in the automated insulin dosing system that led to misinterpretation of the electronic signal remains unclear.
Manufacturers are reportedly not only marketing unauthorized diabetes management devices, but also using an algorithm not evaluated by FDA for devices to convert raw data to glucose levels that patients see.
The agency declined to comment on any specific product. But the developers of OpenAPS say
FDA’s notice “is the result of a report of a single patient outside of the USA” who used Abbott’s FreeStyle Libre continuous glucose monitoring system in conjunction with the MiaoMiao FreeStyle Libre reader plus an “unspecified DIY closed loop system using an unspecified version of the OpenAPS algorithm.” The developers add that “further information has not been provided to DIY developers at this time despite efforts to learn more” but the notice “brings up something very important we need to address; an opportunity for the DIY community to double down on its commitment to radical transparency.”