People with diabetes are building their own home-made medical devices

After Dana Lewis was diagnosed with type 1 diabetes at the age of 14, it took her some time to get over the initial awkwardness of having to wear an insulin pump. She eventually succeeded, but another problem remained: Alarms linked to her continuous blood glucose monitor (CGM) sometimes failed to wake her up at night.

Lewis refused to accept this. Finding a solution led her to figure out how to customize the volume on her CGM and then, design her own artificial pancreas system. She’s not the only one doing it these days.

The average person with Type 1 diabetes will experience 65,000 insulin injections and 80,000 blood sugar measurements over their lifetime — essential parts of life with autoimmune disease, in which the pancreas no longer produces produce enough insulin to regulate blood sugar. People with Type 1 diabetes tend to require constant monitoring of insulin and blood sugar levels.

The cause of type 1 diabetes isn’t clear — and neither is the outlook for a cure. Although type 1 cases account for only 5 to 10 percent of diabetes cases overall, the United States currently has about 1.6 million patients. Although the widespread increase in obesity and type 2 diabetes tends to get more attention, the prevalence of type 1 diabetes is also increasing worldwide. This has led to a growing need for technologies that can monitor the health of people with diabetes and reduce the health complications associated with the disease.

And that includes home-made technologies that are beyond the reach of the Food and Drug Administration, or any other health agency.

Recent years have seen the emergence of do-it-yourself (DIY) monitoring systems that can allow Type 1 diabetics 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 to gauge how many systems are malfunctioning.

The DIY phenomenon arose out of growing frustration in the diabetes community about regulatory approval delays for new technologies. That anger was most evident in 2013, when the hashtag #WeAreNotWaiting started trending on social media sites, promoted by diabetics who felt that while medical technology was advanced enough, To provide them with life-changing solutions, health regulations stand in the way. make these tools available. Frustrated with the medical profession, they took to the internet to find support — and many patients realized they were not alone.

Lewis said such delays are “part of a broader healthcare-related problem” and are not unique to diabetes technology. “Medical technology and healthcare in general are many years behind it.”

In 2015, Lewis and two others (including her husband) co-founded OpenAPS, a web-based community project to make the design for an open source artificial pancreas system available to the public. .

Dana Lewis

The core features of the DIY system are: an insulin pump; a CGM; and a smartphone or mini computer with an app (such as OpenAPS) running open source algorithms that can determine the appropriate time and amount of insulin doses and can also link to the insulin pump and CGM .

OpenAPS is the first open source DIY system. Since then, others have popped up, including Android APS (which also uses OpenAPS’s algorithms) and Loop (which runs on other novelty algorithms). The requirements for using these systems are not always uniform. For example, 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 a person’s insulin pump, Android APS users may also need a radio bridge.

According to Lewis, there are thousands of people who make their own type 1 diabetes devices. It is difficult, she said, to provide a more precise number because people “continue to make their own and switch to [non-DIY] recurring trading system”, so there’s a bit of a “revolving door”.

Lewis said she sometimes hears of people with diabetes struggling with the DIY space because of confusion related to technology. “But it’s less frequent than it used to be,” she said, pointing to “a large online community that is ready to help anyone in need and also encourage them to try.”

Lewis says programmer-level tech skills aren’t necessary, but successful DIY requires users to follow some guidelines and “ask for help if you get stuck, instead of giving up.” .

Lewis and others can personally attest that these home remedies can help people with diabetes sleep better because they no longer have to wake up in the middle of the night to regulate their insulin levels. An independent study from 2018 also highlights other quality of life benefits, such as better blood sugar, less time to do diabetes work, the ability to walk longer distances, and more. longer distances without worrying about medical equipment breaking and feeling better overall. The number of DIYers continues to increase worldwide.

However, such unregulated systems are not without risk. In May 2019, after a person with diabetes accidentally overdosed on insulin while using an unauthorized device, the FDA issued a warning against the uncontrolled use of diabetes technologies. . “It should be noted that the FDA has not evaluated the safety and effectiveness of unauthorized diabetes management devices or systems that combine devices in unintended ways. Note that the use of unauthorized devices and systems may give you inaccurate results and present unknown risks,” the administration wrote.

However, it is perfectly legal to develop these medical devices, as long as the creators are not trying to monetize them.

Do-it-yourself can also be an awkward topic for doctors to discuss with their patients. If they assert too strongly an unregulated technology, there could be a risk of a malpractice lawsuit. But if they express strong objections, it can destroy relationships with patients.

Dr David Ahn at Hoag Memorial Presbyterian Hospital in Newport Beach, California, says another concern is the prospect of having to fix technical problems that DIY novices may encounter. He told The Daily Beast that a significant number of doctors are fundamentally of the opinion that DIY technology is unregulated, which means it’s dangerous – so don’t do it. But he also notes that a sizable percentage of doctors can also say, “You can use it if you want, and I’ll try to help as much as I can, but in the end you have to be on your own. risk”.

Ahn was first introduced to the DIY diabetes device circa 2013–2014. Although “the clinical community has become more tolerant” of the movement in recent years, he also points out that “only a very small number” of doctors are willing to explicitly recommend DIY technology. Ahn said he would “occasionally recommend it to patients who might be ideally suited for such a system.”

In the meantime, DIYers will continue to design new solutions. Lewis notes the corresponding challenge of making these new solutions “more accessible and more affordable for all who want to use them”.