Hackers

Frustrated patients and their families are starting to meddle with medical devices to make them more useful, according to recent media reports.

It centers around Jason Adams,a business-development executive by day and a molecular biologist by training, had never considered himself a hacker. That changed when he discovered an off-label way to monitor his 8-year-old daughter’s blood-sugar levels from afar. His daughter Ella has Type 1 diabetes and wears a glucose monitor made by Dexcom Inc. The device measures her blood sugar every five minutes and displays it on a nearby receiver the size of a pager, a huge advantage in helping monitor her blood sugar for spikes and potentially.

She wears DexCom’s continuous glucose monitor, but the device doesn’t transmit blood sugar data to the internet – so Adams found a way to do it anyway.

Adams discovered NightScout, “a system cobbled together by a constellation of software engineers, many with diabetic children, who were frustrated by the limitations of current technology,” the subscription-only story says. The open-source system hacks into the DexCom device, uploads its data online and allows caregivers to check their beloved diabetics’ blood sugar levels remotely. In Adams’ case, he checks Ella’s glucose on his Pebble smartwatch.

“It isn’t perfect,” admits Adams. “It drains cellphone batteries, can cut out at times and hasn’t been approved by the Food and Drug Administration. But for many, it has filled a gap.”

But it’s a long road for these kinds of device upgrades to get actual regulatory approval – which is why the FDA is allowing these unapproved uses slide by, since users are finding it so beneficial. DexCom’s working on developing a device that has this kind of functionality built in, but it could take quite a while to receive approval.

“The FDA acknowledges the frustration and doesn’t want to be seen as standing in the way of innovation,” states an FDA spokeswoman. “The FDA notes there are different requirements in Europe for device approvals and that approvals depend on when manufacturers submit their applications to U.S. regulators.”

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