A Conversation with Open Artificial Pancreas System Creator Dana Lewis

Mary Green

Speaking with 28-year-old Dana Lewis about her 2013 creation of the Open Artificial Pancreas System (Open APS) is a rapidfire tutorial demonstrating how inspiration, initiative and keen insight (along with a tad bit of impatience) led to the development of a technology designed to reduce the burden of type 1 diabetes (T1D).

The Open APS essentially combines open-source software – for which the original source code is made freely available for distribution and modification – and readily available hardware in a do-it-yourself configuration that allows closedsource (proprietary) medical devices to communicate with one another about a person’s blood glucose levels. As a result of this communication, and following the same basic diabetes “math” that the person would normally perform to adjust their insulin levels, insulin is delivered automatically and precisely to keep blood glucose in a safe range overnight and between meals.

Diagnosed with T1D as a high school freshman, Lewis’s inspiration came from her inability to wake up to her continuous glucose monitor (CGM) alarms, which signaled when her blood sugar had dropped to dangerously low levels. Lewis initially pulled information from her CGM for the sole purpose of creating louder alarms. “But once I got the data off the device and created a system to make louder alarms, I then started creating buttons to snooze those alarms,” she says. “And because I was pressing buttons all the time, I was actually telling the system what I was doing, so I started on programming.”

Lewis works in social media for a network of marketing communications agencies, but growing up in a household full of engineers trained her to think like one: “Very much like the engineering approach, programming is thinking logically and telling the computer what you want it to do,” she says. “It’s just a matter of automating and commanding the computer to do the same diabetes math you do in your head, but just on a schedule and in an automatic fashion so every 5 minutes it does something so you don’t have to.”

“Because I was pressing buttons all the time, I was actually telling the system what I was doing and had a real-time feed of data,” she continues. “Once I had this real-time feed of data, we were next able to create a predictive algorithm, which is what became the open loop system.”

Shortly thereafter, she and system co-creator and thenboyfriend (now-husband) Scott Leibrand crossed paths with another independent developer who had figured out how to communicate data directly to his insulin pump. “We plugged his code and his piece of the puzzle in, and that’s what created the hybrid closed-loop system.”

Although the couple’s DIY efforts circumnavigated the FDA medical device approval pathway that commercially systems in development must undergo, Lewis emphasizes how important she considers system safety. “Since it’s not FDAapproved, people that have decided to use it have to take responsibility for doing it,” she says. “A very important part of our communications is that you need to understand that it will break, and you need to understand when, and how, and why it will break...and how to fix it. Yes, it’s amazing, but it also takes a lot of monitoring and a lot of time and attention, and it’s a different way of doing things. It’s not always better, it’s not always worse, it’s just different.”

Beyond meeting an unfulfilled need in the diabetes community, Lewis’s efforts have had an additional, unanticipated upside.

“Members of the diabetes industry have been very collaborative and have been bringing innovators to their companies to talk with us and have been rethinking the way their product pipeline is developing. Because the Open APS operates from an open-source code, any company in the world can take that code and pull it into their system. We’re actually hoping that companies are doing that—reviewing our code, looking to see what our features are and how they work, and allowing for data portability and usability to make their systems better, as it’s critical information for the end-user.

“I think everybody at these companies, at the FDA, and all of individuals with diabetes, we all have the same shared goal, which is to make life with diabetes better,” she continues. “And we each have different roles and opportunities to make a difference, both in the short–term and the long–term. We – people with diabetes – are focused on the short-term. We have a problem tonight. We need to fix it tonight. We can’t wait six months or a year or five years to make it better. And I think that respect and that realization of the shared focus is really important, and I think that’s what keeps everyone moving forward in the right direction.”