Affecting more than 400 million people worldwide, diabetes has gained a reputation as one of the most significant health crises in the last century. According to the CDC, 32 million Americans—one-in-ten— have diabetes and suffer from minor to severe symptoms.
In patients of demographics, the inability to produce and regulate glucose levels sets off a diverse set of chain reactions, ranging from unpredictable fits of fatigue to increased blood pressure to potential kidney failure and, in some acute cases, premature death. For the optimal quality of life, diabetics need access to specialized treatments—like consistent insulin injections—to perform day-to-day tasks and ensure glucose regularity.
Although diabetes is life-threatening when left unattended, this disease is highly treatable with the right resources and tools. While lifestyle adjustments and constant vigilance are vital to regulation, individuals diagnosed with diabetes also rely on innovative, state-of-the-art medical treatments and devices to achieve a fulfilling life, free of debilitating health complications.
Recent technological advancements have vastly improved the diabetic experience, as medical professionals discover revolutionizing treatments, enhance medication safety, and streamline procedures. As medical scientists and physicians work to gain a firmer grasp on diabetes and its ever-changing complications, diabetics can integrate new-and-improved techniques and treatments, making life with diabetes less burdensome and more manageable.
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By Vidya Murthy, vice president of operations, MedCrypt.
Type 1 diabetes is a way of life. It is a chronic condition in which the pancreas creates little to no insulin. Those living with the condition, or type 2 insulin treated diabetes, must diligently monitor their carbohydrate intake, at a per-gram precision, to calculate and manage insulin levels. This occurs 24 hours a day, seven days a week.
This means regularly getting up in the middle of the night when a glucose monitor alarms as insulin levels either spike or drop precipitously, calculating insulin requirements and then either administering an insulin injection or eating something.
over the last 20 years has transformed how treatments are planned and
delivered, namely two separate hardware components evolved 1) In the 1970s, pumps
were developed that
could dispense insulin and 2) In 1999, the
continuous glucose monitor eliminated the finger prick for point-in-time insight, and instead
continuously tracked sugar levels. These devices were clinical leaps that
advanced the quality of care for patients, but these technologies did not
evolve ‘together.’ They lacked the ability to connect with each other and thus
required that patients actively participate in the delivery of care.
Patients were looking for a solution and began to develop their own alternative. “Looping,” as the solution became known in the diabetic community, involved overriding the default algorithm that came with a pump and feeding data from a glucose monitor into the calculation. Doing this required multiple pieces of technology to be connected into a system that could be managed by an end-user. It allowed diabetics to experiment with treatment plans — something device manufacturers and the FDA could neither regulate nor monitor.
Understandably, most patients don’t have access to the right funds to invest into technologies like these to help with their diabetes. Fortunately, there are online services now available that pay cash for diabetic test strips. A quick search online will produce plenty of options to choose from.
that allowed this level of manipulation were not commercially prevalent, as
manufacturers continuously work to improve the security posture of their
products. It therefore became common to source a legacy pump off eBay or
Craigslist from others in the community. Once these devices were procured,
there are multiple open source solutions available to enable even those who are
not tech-savvy to build a system that works for them. Patients were clearly
looking for a solution that was not available on the market and found a way to
change their quality of life by hacking existing technology.
“Looping” introduced a variety of concerns, including whether patients truly understood the calculations that had been introduced and how manipulations of those calculations impacted patient care. This unregulated solution meant a level of uncertainty around security as well — could a malicious actor intentionally manipulate a solution to cause harm to an individual?
Many in the community cited parallels to open-source software as a response to these concerns, arguing continuous improvement of open source solution is more secure than proprietary solution development. The FDA’s regulatory purview does not seem to extend to the solution at this time as there is no commercial gain nor medical advice being dispensed from this community.
2006, the first project to pursue an artificial pancreas
was launched. With time and more research, automated insulin delivery, also
known as a closed-loop system, became the modality of care preferred by both
clinicians and patients. This meant that a continuous glucose monitor would
provide data to an insulin pump to manage a patient’s needs. Industry leader
Medtronic was the first to make this technology commercially available in September 2016.
Cost considerations, personal preferences and the idea of control continue to fuel the DIY-artificial pancreas community’s efforts to equip patients to manage their own care. Even as the FDA advocates for more rigorous cybersecurity controls being built designed into devices, the impact of patient-hacked solutions is indelible in the larger ecosystem and will continue to inform the evolution of commercially available solutions.
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