After Dana Lewis was diagnosed with Type 1 diabetes at age 14, it took her some time to overcome her initial awkward feelings about having to wear an insulin pump. She eventually succeeded, but another problem remained: The alarm linked to her continuous glucose monitor (CGM) sometimes failed to wake her at night.
Lewis refused to accept this. Her search for a solution led her to find a way to customize the volume on her CGM and, later, to engineer her own artificial pancreas system. She’s far from the only person doing it these days.
The average person with Type 1 diabetes will undergo 65,000 insulin injections and 80,000 blood sugar readings during their lifetime—essential parts of living with an autoimmune disease in which the pancreas ceases to produce enough insulin to regulate blood-sugar levels. People with Type 1 diabetes tend to require continuous supervision of insulin and blood-sugar levels.
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The causes of Type 1 diabetes are unclear—and so is the prospect of a cure. Although Type 1 cases represent only 5 to 10 percent of diabetes cases overall, the U.S. now has about 1.6 million patients. Though the widespread increase of obesity and Type 2 diabetes tends to receive more attention, rates of Type 1 diabetes are also rising worldwide. This has resulted in a growing demand for technologies that can monitor the health of people with diabetes and reduce health complications associated with the disease.
And that includes home-brewed technologies that fall outside of the purview of the Food and Drug Administration, or any other health authorities.
Recent years have seen the emergence of do-it-yourself (DIY) monitoring systems that can enable Type 1 diabetes patients to receive insulin through a more convenient, automated process. At the same time, however, the DIY arena is unregulated and uncharted territory. There is no reliable way of assessing how many systems malfunction.
The DIY phenomenon arose out of a collective growing frustration in the diabetes community about regulatory approval delays for new technologies. That anger was best on display in 2013, when the hashtag #WeAreNotWaiting began trending heavily on social media sites, promoted by diabetes patients who felt that while medical technology had advanced enough to provide them with life-changing solutions, medical regulations stood in the way of making these tools readily available. Exasperated by the medical industry, they took to the internet to find support—and many patients realized they were not alone.
Such delays are “part of a broader issue related to health care” and are not unique to diabetes tech, said Lewis. “Medical tech and health care in general is years behind the technology itself.”
In 2015, Lewis and two others (including her husband) co-founded OpenAPS, a web-based community project to make a design for an open-source artificial pancreas system available to the public.
The DIY closed loop OpenAPS system.
Dana LewisThe core features of a DIY system are: an insulin pump; a CGM; and a smartphone or mini-computer with an app (such as OpenAPS) that runs open-source algorithms that can determine the appropriate time and quantity of insulin doses, and that can link with the insulin pump and CGM.
OpenAPS is the first such open-source DIY system. Others have since emerged, including Android APS (which uses OpenAPS’s algorithms too) and Loop (which runs on other novel algorithms). The requirements for using these systems aren’t always uniform. For instance, Loop for iOS requires a radio bridge (about $150) to facilitate communication between devices, along with an Apple developer license ($99 per year). Depending on one’s insulin pump, users of the Android APS might also need a radio bridge as well.
According to Lewis, there are currently thousands of DIY users of Type 1 diabetes tools. Providing a more precise number is difficult, she said, since people “go on to DIY and off to [non-DIY] commercial systems periodically,” so there is “a bit of a revolving door.”
Lewis said she occasionally hears about people with diabetes who struggle with the DIY space because of tech-related confusion. “But it’s less frequent than it used to be,” she said, pointing out the “large community online willing to help anyone who gets stuck and also encourage them to try.”
Programmer-level tech skills are unnecessary, but successful DIY does require users to follow a set of instructions and to “ask for help if you get stuck, rather than giving up,” said Lewis.
Lewis and others can personally attest that these home-brewed tools can help people with diabetes sleep better since they no longer have to wake up in the middle of the night to adjust their insulin levels. One independent study from 2018 also highlighted other quality-of-life benefits, such as better blood sugar, less time spent doing diabetes work, ability to travel longer distances without concern over failing medical devices, and feeling better overall. The number of DIYers continues to grow worldwide.
However, such unregulated systems are not without risk. In May 2019, after a person with diabetes suffered an accidental insulin overdose while using an unauthorized device, the FDA issued a warning against the use of unregulated diabetes technologies. “Be aware that the FDA has not evaluated the safety and effectiveness of unauthorized diabetes management devices or of systems that combine devices in unintended ways. Be aware that the use of unauthorized devices and systems may give you incorrect results and have unknown risks,” the administration wrote.
Nevertheless, development of these medical devices is completely legal, so long as creators don’t attempt to make money off them.
DIY can also be an awkward topic for doctors to broach with their patients. If they give too strong an endorsement of an unregulated technology, then there could be a risk of a malpractice suit. But if they express harsh opposition, it could destroy the relationship with the patient.
Another concern is the prospect of having to troubleshoot technical issues that novice DIY users might encounter, said Dr. David Ahn at Hoag Memorial Hospital Presbyterian in Newport Beach, California. He told The Daily Beast that a significant number of doctors essentially take the position that DIY tech isn’t regulated, which means it’s dangerous—so don’t do it. But he also noted that a sizable percentage of doctors might also say: “You can use it if you want, and I’ll try to help as best as I can, but ultimately use at your own risk.”
Ahn was first introduced to DIY diabetes devices around 2013–2014. Although the “clinical community has become more tolerant” of this movement in recent years, he also pointed out that “only a very slim minority” of doctors are willing to explicitly recommend DIY tech. Ahn said he will “occasionally recommend it to patients who might be ideally suited for such a system.”
In the meantime, DIYers will continue to engineer new solutions. Lewis noted the corresponding challenge of making these new solutions “more accessible and affordable to everyone who would like to use them.”
