From Teen Diagnosed at 14 to Artificial Pancreas Pioneer: Dana Lewis Brings Hope to Millions with Diabetes

Dana Lewis: The artificial pancreas integrates an insulin pump with CGM data to automatically regulate blood glucose and manage fluctuations in blood sugar levels. Initially, I did not intend to create an artificial pancreas system. My original goal was simply to address the issue of receiving alerts from my CGM (continuous glucose monitoring) device. Therefore, I extracted data from my CGM device and transmitted it to a smartphone or computer, thereby replacing the existing medical equipment for providing me with alerts.

Upon completion of the database collection, I will develop a predictive algorithm based on this data to enhance the intelligence of the alert system. Since none of us appreciate being awakened from sleep by alarms prompting blood glucose adjustments, our algorithm will, within a year, be capable of sending commands to the insulin pump to automatically regulate blood glucose levels without causing any disruption to sleep.

I don’t want to be the only person with an artificial pancreas; I enjoy sharing. If we were to follow conventional channels—obtaining regulatory approval, conducting clinical trials, and pursuing market commercialization—it would take a long time before other people with diabetes could access such products. That is why we chose to collaborate with the open-source diabetes community to create OpenAPS, sharing our methods, data, and systems so that others can build their own artificial pancreas systems using their own diabetes medical devices.

Dana Lewis: The DIY artificial pancreas is not a medical device in itself. It is a system that leverages your existing diabetes devices (an insulin pump and a CGM) along with a computer, running the OpenAPS algorithm to automatically send commands to the insulin pump for adjusting basal insulin delivery.

Since it is a DIY device rather than an all-in-one solution designed for all patients, how does the OpenAPS algorithm respond when blood glucose (BG) levels rise or drop sharply, when BG data are missing or exhibit sudden jumps, or when values deviate significantly from the normal range? To address these scenarios, we have implemented specific design measures: the system issues temporary basal rate commands to fine-tune blood glucose levels, rather than administering large boluses of insulin through an automated process. Our calculations are conservative, and all commands and operations must be executed under the premise of absolute safety. If any of these issues occur, the system will either power down or reset its data, reverting to pre-programmed standard therapeutic protocols, thereby ensuring that patients are not exposed to any health risks.

Users of OpenAPS generally do not need to manually administer additional insulin to regulate blood glucose levels. Since adopting OpenAPS, I have reduced the frequency of consuming extra candies to correct blood sugar fluctuations. When equipped with a compact artificial pancreas system, it responds to any blood glucose variations just like a healthy pancreas, maintaining blood glucose levels within the normal range for 90%–100% of the day. This represents a significant improvement compared to my previous lifestyle.

Currently, I have several such systems: one on my office desk, one by my bedside at home, and one clipped to my jeans when I am out. My blood glucose levels remain in a state of self-regulation most of the time. This allows me to spend less effort checking my blood glucose levels and reduces the frequency of manual medication administration, while keeping my blood glucose values consistently within the normal range.

Dana Lewis: Since adopting the smart alarm system, my diabetes management has improved significantly. This closed-loop system has markedly reduced the effort required to maintain normal blood glucose levels. Two clear clinical outcomes have been observed: first, a reduction in average blood glucose levels (or HbA1c), and second, an increased time spent within the target glycemic range. Another way to measure the impact of this technology is by the reduction in time patients spend managing their diabetes, along with improved sleep, better glycemic control, and an enhanced overall quality of life.

Not only has quality of life improved, but as of July 2016, more than 103 diabetic patients worldwide had been using this artificial pancreas system. Follow-up studies of the initial 18 users demonstrated that the system effectively stabilized blood glucose fluctuations and enhanced the overall quality of life for their entire families.

Dana Lewis: The FDA’s regulation of medical devices is a commercial matter. I have never been interested in founding a company or selling products. In fact, others have already done so. Two new medical technology companies, Bigfoot Biomedical and Beta Bionics, are dedicated to bringing artificial pancreas systems to market. Traditional companies are also conducting clinical trials on artificial pancreas systems. However, when I began this research three years ago, they were still far from emerging. Even if they had already started their research, their products would not reach the market until 2017 at the earliest, or even 2018.

OpenAPS aims to accelerate the widespread adoption of safe and effective artificial pancreas technology. Therefore, we have chosen to disseminate this technology rapidly through an open-source approach, rather than following traditional manufacturing and sales models. Although our solution is not FDA-approved and cannot be commercially sold, it drives greater societal impact compared to conventional approaches.

We have learned a great deal from our community work: members of the community collectively possess over 24,000 hours of usage experience, and I personally have been using this system for more than 600 days. We share the technical insights we have gained with all companies and individuals dedicated to advancing artificial pancreas technology, helping them enhance user experience. Meanwhile, hundreds of users who have established their own closed-loop artificial pancreas systems are educating their medical device providers and other patients about what they can expect and receive once this business model is approved.