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.
Technology 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.
Devices 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.
In 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.