FDA Cracks Down on DIY mHealth Platforms for Diabetes Care Management
FDA has issued a warning that jury-rigged, altered or unauthorized mHealth platforms for diabetes care management could cause harm, even death.
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By - The US Food and Drug Administration is cracking down on do-it-yourself mHealth devices for people living with diabetes, saying the jury-rigged technology could be fatal.
The agency pointed out that digital health devices like continuous glucose monitoring systems (CGMs), insulin pumps and automated insulin dosing (AID) systems are designed to work only in the way their manufacturers intended, with specific methods of integration. Changing them, it said, could change the way in which blood glucose is measured or insulin is delivered.
“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 notice reads. “Patient use of unauthorized diabetes management devices, alone or along with other devices, could result in inaccurate glucose level readings or unsafe insulin dosing. These inaccuracies may lead to injuries requiring medical intervention, such as severe low blood sugar, coma, diabetic ketoacidosis (buildup of acids in blood), and death.”
Reports of mobile health and telemedicine technology being hacked or reconfigured have been around for years. Aside from the idea that mHealth devices can be hacked to cause harm or steal data, some people have sought to change how the devices work in a bid to improve them or create workarounds that save time or money.
In this case, FDA officials noted they’d received a report of someone using an unauthorized mHealth device that uses an unauthorized algorithm to convert signals from an approved glucose sensor into a glucose value, which is used by the patient to determine how much insulin to take.
“Glucose values from this unauthorized continuous glucose monitoring system were sent to an unauthorized automated insulin dosing device to drive insulin dosing,” the FDA reported. “The automated insulin dosing system gave too much insulin in response to repeated incorrect high glucose values sent from the continuous glucose monitoring system. This unauthorized system resulted in an insulin overdose requiring 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.”
“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,” the agency added.
The FDA also warned that some mHealth vendors are marketing unauthorized devices that convert glucose sensor readings to glucose values.
“The FDA has not evaluated the algorithm that these unauthorized devices use,” the agency said. “The algorithm may return inaccurate glucose values.”
This isn’t the first time the agency has targeted unregulated mHealth technology.
Just last month, the agency issued a warning on consumer-facing mHealth apps and devices that claim to diagnose concussions. Any connected care technology designed to evaluate head injuries, it said, needs to be managed by a clinician.
“I want to be clear, there are currently no devices to aid in assessing concussion that should be used by consumers on their own,” Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in the press release. “Using such devices can result in an incorrect diagnosis after a head injury that could lead a person with a serious injury to return to their normal activities instead of seeking critical medical care, putting them at greater danger.”
In addition, the FDA has gone after developers of mHealth platforms that advertise more than they should – from apps that pledge to diagnose cancer from photographs of skin lesions to diabetes apps that don’t accurately measure glucose levels – and, more recently, companies who say their mHealth device can accurately replicate a mammogram.
