Diabetes patient advocate Renza Scibilia with her continuous glucose monitor, used in innovative DIY health technology.

(Courtesy of Scibilia)

In the fall of 2017, patient advocate Renza Scibilia told a conference of endocrinologists in Australia about new, patient-developed artificial pancreas technology that helped her manage her Type 1 diabetes.

"Because it's not a regulated product, some [doctors] were worried and said 'What if it goes wrong?'"

"They were in equal measure really interested and really scared," recalled Scibilia. "Because it's not a regulated product, some were worried and said 'What if it goes wrong? What is my liability going to be?'"

That was two years ago. Asked if physicians have been more receptive to the same "looping" technology now that its benefits have been supported by considerable data (as Leapsmag pointed out in May), Scibilia said, "No. Clinicians are still really insecure. They're always going to be reluctant to accept consumer-driven technology."

This exemplifies a major challenge to the growing Do-It-Yourself (DIY) biohealth movement: physicians are unnerved and worried about innovations developed by patients and other consumers that haven't been tested in elaborate clinical trials or sanctioned by regulatory authorities.

"It's difficult for patients who develop new health technology to demonstrate the advantage in a way that physicians would accept." said Howard DeMonaco, visiting scientist at MIT's Sloan School of Management. "New approaches to the treatment of diseases are by definition suspect to clinicians. Most are risk averse unless there is a substantial advantage to the new approach and the risks in doing so appear to be minimized."

Nevertheless, the DIY biohealth movement is booming. About a million people reported that they created medical innovations to address their own medical needs in surveys conducted from 2010-2015 in the U.S., U.K., Finland, Canada and South Korea.

Add in other DIY health innovations created in homes, community biolabs and "Maker" health fairs, and it's clear that health care providers are increasingly confronted with medical devices, information technology, and even medications that were developed in unconventional settings and lack the blessing of regulatory authorities.

Researchers in Portugal have tried to spread the word about many of these solutions on the Patent Innovations website, which has more than 500 examples, ranging from a 3-D printed arm and hand to a sensor device that warns someone when an osteomy bag is full.

When Reddit asked medical professionals, "What is the craziest DIY health treatment you've seen a patient attempt?" thousands shared horror stories.

But even in this era of patient empowerment, more widespread use of DIY health solutions still depends upon the approval and cooperation of physicians, nurses and other caregivers. And health care providers still lack awareness of promising patient-developed innovations, according to Dr. Joyce Lee, a pediatric endocrinologist at the University of Michigan who advocates involving patients in the design of healthcare technology. "Most physicians are scared of what they don't know," she said.

They're also understandably worried about patients who don't know what they're doing and make irresponsible decisions. When Reddit asked medical professionals, "What is the craziest DIY health treatment you've seen a patient attempt?" thousands shared horror stories, including a man who poked a hole in his belly button with a knitting needle to relieve gas.

Yet DeMonaco and Lee think it's possible to start bridging the gaps between responsible patient innovators and skeptical doctors as well as unprepared regulatory systems.

One obstacle to consumer-driven health innovations is that clinical trials to prove their safety and effectiveness are expensive and time-consuming, as De Monaco points out in a recent article. He and his colleagues suggested that low-cost clinical trials by and for patients could help address this challenge. They urged patients to publish their own research and detail the impact of innovations on their own health, and create databases that incorporate the findings of other patients.

For example, Adam Brown, who has Type 1 diabetes, compared the effects of low and high carbohydrate diets on his blood sugar management, and conveyed the results in an online journal. "Sharing the information allowed others to copy the experiment," the article noted, suggesting that this could be a model to create multi-patient trials that could be "analyzed by expert patients and/or by professionals."

Asked how to convince health care providers to consider such research, DeMonaco cited the example of doctors prescribing "off label" drugs for purposes that aren't approved by the FDA. "The secret to off label use, like any other user innovation, is dissemination," he said. Sharing case reports and other low-cost research serves to disseminate the information "in a way that is comfortable for physicians," he said, and urged patient innovators to take the same approach.

The FDA regulates commercial products and has no authority if consumers want to use medical devices, medications, or information systems that they find on their own.

Physicians should also be encouraged to engage in patient-driven research, said Dr. Lee. She suggests forming "maker spaces in which patients and physicians are involved in designing personalized technology for chronic diseases. In my vision, patient peers would build, iterate, and learn from each other and the doctor would be part of the team, constantly assessing and evaluating the technology and facilitating the process."

Some kind of regulatory oversight of DIY health technology is also necessary, said Todd Kuiken, senior research scholar at NC State and former principal investigator at the Woodrow Wilson Center's Synthetic Biology Project.

The FDA regulates commercial products and has no authority if consumers want to use medical devices, medications, or information systems that they find on their own. But that doesn't stop regulators from worrying about patients who use them. For example, the FDA issued a warning about diabetes looping technology earlier this year after one diabetic was hospitalized with hypoglycemia.

Kuiken, for one, believes that citizen-driven innovation requires oversight "to move forward." He suggested that Internal Review Boards, with experts on medical technology, safety and ethics, could play a helpful role in validating the work of patient innovators and others engaged in DIY health research. "As people are developing health products, there would be experts available to take a look and check in," he said.

Kuiken pointed out that in native American territories, tribally based IRBs working with the national Indian Health Services help to oversee new health science research. The model could be applied more broadly.

He also offered hope to those who want to integrate the current health regulatory structure into the ecosystem of DIY health innovations. "I didn't expect people from the FDA or NIH to show up" he said about a workshop on citizen-driven biomedical research that he helped organize at the Wilson Center last year. But senior officials from both agencies attended.

He indicated they "were open to new ideas." While he wouldn't disclose contributions made by individual participants in the workshop, he said the government staffers were "very interested in figuring out how to engage with citizen health innovators, to build bridges with the DIY community."

"Why should we wait for regulatory bodies? Why wait for trials that take too long?"

Time will tell whether those bridges will be built quickly enough to increase the comfort of physicians with health innovations developed by patients and other consumers. In the meantime, DIY health innovators like patient advocate Scibilia are undeterred.

"Why should we wait for regulatory bodies?" she asked. "Why wait for trials that take too long? There are plenty of data out there indicating the [diabetes looping] technology works. So we're just going to do it. We're not waiting."

Dan Fleshler
Dan Fleshler is a freelance writer and communications consultant who focuses on health and health policy. His work has been published in the New York Times, Quartz, Daily Beast, Diabetes Forecast and Diabetes Mine, among other outlets.

Dana Lewis, pictured in Mount Vernon in 2017, worked with her engineer husband to design an artificial pancreas system to manage her type 1 diabetes.

(Courtesy of Lewis)

For years, a continuous glucose monitor would beep at night if Dana Lewis' blood sugar measured too high or too low. At age 14, she was diagnosed with type 1 diabetes, an autoimmune disease that destroys insulin-producing cells in the pancreas.

The FDA just issued its first warning to the DIY diabetic community, after one patient suffered an accidental insulin overdose.

But being a sound sleeper, the Seattle-based independent researcher, now 30, feared not waking up. That concerned her most when she would run, after which her glucose dropped overnight. Now, she rarely needs a rousing reminder to alert her to out-of-range blood glucose levels.

That's because Lewis and her husband, Scott Leibrand, a network engineer, developed an artificial pancreas system—an algorithm that calculates adjustments to insulin delivery based on data from the continuous glucose monitor and her insulin pump. When the monitor gives a reading, she no longer needs to press a button. The algorithm tells the pump how much insulin to release while she's sleeping.

"Most of the time, it's preventing the frequent occurrences of high or low blood sugars automatically," Lewis explains.

Like other do-it-yourself device innovations, home-designed artificial pancreas systems are not approved by the Food and Drug Administration, so individual users assume any associated risks. Experts recommend that patients consult their doctor before adopting a new self-monitoring approach and to keep the clinician apprised of their progress.

DIY closed-loop systems can be uniquely challenging, according to the FDA. Patients may not fully comprehend how the devices are intended to work or they may fail to recognize the limitations. The systems have not been evaluated under quality control measures and pose risks of inappropriate dosing from the automated algorithm or potential incompatibility with a patient's other medications, says Stephanie Caccomo, an FDA spokeswoman.

Earlier this month, in fact, the FDA issued its first warning to the DIY diabetic community, which includes thousands of users, after one patient suffered an accidental insulin overdose.

Patients who built their own systems from scratch may be more well-versed in the operations, while those who are implementing unapproved designs created by others are less likely to be familiar with their intricacies, she says.

"Malfunctions or misuse of automated-insulin delivery systems can lead to acute complications of hypo- and hyperglycemia that may result in serious injury or death," Caccomo cautions. "FDA provides independent review of complex systems to assess the safety of these nontransparent devices, so that users do not have to be software/hardware designers to get the medical devices they need."

Only one hybrid closed-loop technology—the MiniMed 670G System from Minneapolis-based Medtronic—has been FDA-approved for type 1 use since September 2016. The term "hybrid" indicates that the system is not a fully automatic closed loop; it still requires minimal input from patients, including the need to enter mealtime carbohydrates, manage insulin dosage recommendations, and periodically calibrate the sensor.

Meanwhile, some tech-savvy people with type 1 diabetes have opted to design their own systems. About one-third of the DIY diabetes loopers are children whose parents have built them a closed system, according to Lewis' website.

Lewis began developing her system in 2014, well before Medtronic's device hit the market. "The choice to wait is not a luxury," she says, noting that "diabetes is inherently dangerous," whether an individual relies on a device to inject insulin or administers it with a syringe.

Hybrid closed-loop insulin delivery improves glucose control while decreasing the risk of low blood sugar in patients of various ages with less than optimally controlled type 1 diabetes, according to a study published in The Lancet last October. The multi-center randomized trial, conducted in the United Kingdom and the United States, spanned 12 weeks and included adults, adolescents, and children aged 6 years and older.

"We have compelling data attesting to the benefits of closed-loop systems," says Daniel Finan, research director at JDRF (formerly the Juvenile Diabetes Research Foundation) in New York, a global organization funding the study.

Medtronic's system costs between $6,000 and $9,000. However, end-user pricing varies based on an individual's health plan. It is covered by most insurers, according to the device manufacturer.

To give users more choice, in 2017 JDRF launched the Open Protocol Automated Insulin Delivery Systems initiative to collaborate with the FDA and experts in the do-it-yourself arena. The organization hopes to "forge a new regulatory paradigm," Finan says.

As diabetes management becomes more user-controlled, there is a need for better coordination. "We've had insulin pumps for a very long time, but having sensors that can detect blood sugars in real time is still a very new phenomenon," says Leslie Lam, interim chief in the division of pediatric endocrinology and diabetes at The Children's Hospital at Montefiore in the Bronx, N.Y.

"There's a lag in the integration of this technology," he adds. Innovators are indeed working to bring new products to market, "but on the consumer side, people want that to be here now instead of a year or two later."

The devices aren't foolproof, and mishaps can occur even with very accurate systems. For this reason, there is some reluctance to advocate for universal use in children with type 1 diabetes. Supervision by a parent, school nurse, and sometimes a coach would be a prudent precaution, Lam says.

People engage in "this work because they are either curious about it themselves or not getting the care they need from the health care system, or both."

Remaining aware of blood sugar levels and having a backup plan are essential. "People still need to know how to give injections the old-school way," he says.

To ensure readings are correct on Medtronic's device, users should check their blood sugar with traditional finger pricking at least five or six times per day—before every meal and whenever directed by the system, notes Elena Toschi, an endocrinologist and director of the Young Adult Clinic at Joslin Diabetes Center, an affiliate of Harvard Medical School.

"There can be pump failure and cross-talking failure," she cautions, urging patients not to stop being vigilant because they are using an automated device. "This is still something that can happen; it doesn't eliminate that."

While do-it-yourself devices help promote autonomy and offer convenience, the lack of clinical trial data makes it difficult for clinicians and patients to assess risks versus benefits, says Lisa Eckenwiler, an associate professor in the departments of philosophy and health administration and policy at George Mason University in Fairfax, Va.

"What are the responsibilities of physicians in that context to advise patients?" she questions. Some clinicians foresee the possibility that "down the road, if things go awry" with disease management, that could place them "in a moral quandary."

Whether it's controlling diabetes, obesity, heart disease or asthma, emerging technologies are having a major influence on individuals' abilities to stay on top of their health, says Camille Nebeker, an assistant professor in the School of Medicine at the University of California, San Diego, and founder and director of its Research Center for Optimal Data Ethics.

People engage in "this work because they are either curious about it themselves or not getting the care they need from the health care system, or both," she says. In "citizen science communities," they may partner in participant-led research while gaining access to scientific and technical expertise. Others "may go it alone in solo self-tracking studies or developing do-it-yourself technologies," which raises concerns about whether they are carefully considering potential risks and weighing them against possible benefits.

Dana Lewis admits that "using do-it-yourself systems might not be for everyone. But the advances made in the do-it-yourself community show what's possible for future commercial developments, and give a lot of hope for improved quality of life for those of us living with type 1 diabetes."

Susan Kreimer
Susan Kreimer is a New York-based freelance journalist who has followed the landscape of health care since the late 1990s, initially as a staff reporter for major daily newspapers. She writes about breakthrough studies, personal health, and the business of clinical practice. Raised in the Chicago area, she holds a B.A. in Journalism/Mass Communication and French from the University of Iowa and an M.S. from the Columbia University Graduate School of Journalism.
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