Recently, Wired published an excellent article about techy-savvy parents of children with Type 1 diabetes who are hacking into the code of their children’s diabetes devices to improve upon them.
These parents, who have come of age at a time when they can make complex bank transactions by smartphone, have grown frustrated that continuous glucose monitors can’t transmit blood sugar readings wirelessly. Without wireless readings, continuous glucose monitors do little to provide peace of mind for parents of young children when their offspring leave the house.
Continuous glucose monitor manufacturers are slowly working to make their products wireless and cloud-based. Such an improvement is a prerequisite for the next generation of insulin pumps, which are being designed to be integrated with monitors. Wireless and cloud-based tech is also a must for the development of artificial pancreas and bionic pancreas systems. But such innovations must go through the FDA approval process, which many who have diabetes would describe as torturously slow. Meanwhile, a generation of parents of young children with Type 1 diabetes must settle with wired-only diabetes equipment.
We are no longer a society that waits patiently for innovation. Many parents who are accomplished coders are taking matters into their own hands, and their tinkering is working. Not only have some parents made monitor data accessible wirelessly, some have even improved upon monitor code and made the devices seemingly more accurate.
The FDA, which tightly controls testing on proposed diabetes treatments to ensure patient safety, has been relatively lenient when it catches word that someone is tinkering with their child’s medical device. Basically, the agency is washing its hands of the process, and a FDA official even says in the article that it’s great for parents to have their children’s blood glucose data on their smartphones.
But because this is government we’re talking about, things can’t be that easy. The FDA, which is charged with patient safety, has to walk a fine line with this kind of innovation, and it comes down to distribution. Essentially, if you want to come up with building a better mousetrap for you or your child’s medical devices, that’s fine. The moment you share that idea with others, however, you are going to have a major problem with federal health regulators. Just pressing “send” on an email that contains a new line of code for a CGM could very well subject you to prosecution and fines, unless you somehow have found a way to fund massive amounts of research that proves your new code is safe for all people with Type 1 diabetes.
This isn’t just a case of a government agency being a jerk for no good reason. The FDA has made efforts in the last couple of years to be more responsive to the needs of the diabetes community, holding hearings and online forums to improve how it serves people affected by Type 1 diabetes. One can see why the FDA might be worried about such do-it-yourself hacking, too. Sure, maybe one diabetes dad is a brilliant, careful, meticulous coder who can create a better and safer continuous glucose monitor, but if he posts the code on Facebook, problems might arise. An overeager and sleep-deprived diabetes parent who isn’t as good at coding might make an error that could prove disastrous. The whole point of government regulation of health devices is to prevent shoddy workmanship that could prove harmful.
While there haven’t been any news reports of people being prosecuted by the FDA for sharing ideas on how to tinker with diabetes devices, it is enough to create a chilling effect for this kind of innovation. The author of the Wired story had a heck of a time tracking down one of the leaders of this kind of benevolent diabetes device hacking, for example. Much of this work has been driven underground, and many parents are being forced to reinvent code improvements over and over again.
Thus, we have a problem where the FDA is trying to protect patient safety at the expense of possible improvements in patient health. Not only do scores of individual families miss out on the chance to improve daily diabetes care, but we may be holding back better diabetes devices for all. There are rumors that some enterprising diabetes hackers may already have mastered the code needed for the bionic pancreas, but they can’t even tell their neighbors what they are doing.
I think there is a way for the FDA to stick to its core mission of patient safety while also allowing important, decentralized innovation to occur. Regulations should be written that allow individuals to share instructions for how they improved upon their diabetes devices alongside a disclaimer saying that the improvement has not been tested by the FDA for safety or effectiveness. Those who want to access the new code or instructions must opt in and say they have read the disclaimer. Buyer beware.
It’s similar to how the FDA has handled natural dietary supplements. If you look on the packaging of most natural health products, any claim of benefits comes with a small mark that leads to a footnote. The footnote says the FDA has not signed off on the treatment and has not evaluated the product’s health claims.
Families with Type 1 diabetes should be able to weigh the risk vs. reward of each new reported diabetes device improvement, just as they weigh the risk versus reward of every approved diabetes treatment.