We’re thrilled to see so much innovation cropping up in the “real world” of diabetes these days, with many do-it-yourself creations moving the needle forward. That’s a big part of what DiabetesMine is all about, and the impetus behind the grassroots #WeAreNotWaiting movement that kicked off in late 2013.
Just recently, we shared the story of the Mazlish family in New York family (aka the Bigfoot clan), and how they’ve been using a homemade closed loop system for 2+ years now.
Today, it’s a privilege to share another story from the opposite end of the country where a soon-to-be married couple, Dana Lewis and Scott Leibrand, have also “closed the loop” with their own homemade tech known as the Do-It-Yourself Pancreas System (or DIYPS, for short).
First, meet Dana and Scott. Diagnosed with type 1 during her freshman year of high school, Dana’s from the greater Seattle, WA, area and works as senior manager of digital content for a non-profit health system. Of course, many in the online advocacy world know her as the founder of the weekly #HCSM chat years ago, which later inspired the #DSMA chat on Twitter each week. The man beside her is Scott, a “type awesome” with a computer networking engineering background and career.
They’re both busy professionals, working on this DIYPS project in their spare time, which is impressive! Check out this great Q&A with the couple from March 2014 for more detail on their story and how their D-tech project came to be, in November 2013.
In early February, they took their effort to the next level by launching the #OpenAPS (Open Artificial Pancreas System) project, aimed at bringing closed loop functionality to anyone who wants to delve into it for themselves. Like so many in this tech-savvy #WeAreNotWaiting open-source world, they’re sharing pretty much everything online for free — allowing independent users, researchers, non-profits and even industry folk to experiment and hopefully make D-tech better for all of us.
We connected with the couple by phone recently, and here’s what they had to say about the new #OpenAPS effort and how the DIYPS system has helped them in their personal lives — especially now, leading into their upcoming wedding in August (!)
DM) OK, what exactly is the Do-It-Yourself-Pancreas System?
Dana) If you look at the setup, it doesn’t look like an AP system. It’s very underwhelming to look at, but that’s the beauty of it.
The basic idea of the system and physical components are a Raspberry Pi (credit card-sized computer), a Medtronic Minimed pump, a Dexcom CGM, and a Nightscout uploader. They are really basic physical components, and it’s battery powered and stays in close proximity to the user. It uses an algorithm that basically asks, ‘Hey, do you need this much insulin as a bolus?’ And it converts that to a basal rate. That’s the only configuration we had to do.
Scott) The OpenAPS we have today is based on existing components we had for DIYPS. We use the Nightscout uploader, it does all the calculations in the cloud, and then the Raspberry Pi just has to connect to the Internet and download that to the pump. It’s a very dumb system, actually, but that’s because it’s designed to be simple. This is not the same kind of “blackbox algorithm” that most Artificial Pancreas projects use, and it’s designed to be extremely safe. It just sets a temp basal for 30 minutes at a time, so there’s minimal risk of administering too much insulin — and even if it did, it can’t administer enough to do any harm. We have been very mindful during this entire process of making it an easy-to-understand system and making sure it’s completely safe and very predictable, using the same bolus and basal paradigm used in pumping.
There are things we want to make better, like compacting the uploader so it only takes up half a pocket and is more portable. It is portable with a battery pack now, but it’s just not small enough to be practical to carry all over the place right now.
When we saw you both at the most recent D-Data Exchange event, you hadn’t yet closed the loop… This all moved quicker than you were expecting, right?
Scott) We’ve been going non-stop since December, and every night for a year from when we first got data off the CGM, in mid-November ’13.
Dana) When we looked at closing the loop, we said, “Hey, we can do this by Aug. 1 for the wedding….” we ended up doing that in two weeks and closed the loop for the first time in December. So, we have many months to get it perfected and running the best we can. A big question now is, how it will be used at the wedding?
What’s the personal experience been like for you using this DIYPS?
Dana) This has changed how I live with diabetes, regardless of all the data. That’s not something to overlook in all of this. That approach is revolutionary, and it’s something we want to translate and make available to other people and clinicians. We think it’s a novel way to approach something everyone needs in living with diabetes, to make these decisions and get to extremely better outcomes.
But what’s fascinating to me is that if you took all my tech away, I’d still be so much better based on what I’ve learned from using the system.
OK, it sounds pretty awesome. But what about those of us who aren’t very tech-savvy, and may not be able to put this together for ourselves?
Dana) My goal is to help educate people about how I’ve used this. I don’t want to discourage people to think you have to be an engineer, or have some tech knowledge to get this set up. There are a lot of people involved, and there is so much support — and that’s why we have this all being shared and discussed openly.
Why open-source and community-based?
Scott) The reason this worked is because a bunch of people found each other. We couldn’t have done this without John Costik (a D-Dad who began the Nightscout/CGM in the Cloud movement), and Ben West, who helped with the CareLink package. There are so many various people who are a part of this. It’s a social movement as much as it is a technical thing.
How do you think this changes the game for industry and regulated products?
Scott) Our dream here is to get to a point where the simple APS is considered just the standard way of doing things. The diabetes companies can start innovating on the harder problems. We want to free up their time, and make these things come together…
Dana) We want them to make better pumps and sensors, and be able to focus on that. We don’t want to underplay their role in all of this. We wouldn’t be here without them. Ideally, you could pick whichever pump and CGM brand you like, and then use those devices with this algorithm simply by plugging it in and turning it on. That’s the dream, to have this plug-and-play system for closed loop. You shouldn’t be limited by proprietary products and brands of technology.
And you have talked with the FDA about all of this?
Dana) Yes. I am constantly surprised when we reach out to the FDA at how receptive they are when they respond. It’s clear that we have equal rights to initiate these regulatory conversations. Last year at this time, we never imagined two individuals could go talk to the FDA about this setup and get anywhere meaningful!
Scott) They’re listening. It will be interesting to see where we go from here, as we get into more AP systems that are still being developed.
What’s the next milestone for your project?
Dana) There is not a specific timeline or deadline. We are in Phase I, so to speak — getting other innovators building their own loop. With this Call to Action that’s happening now, we want to share the data and build upon what we’re all learning. We are also talking to potential partners and sponsors for clinical trials.
Scott) The timeline is dependent on how quickly we get certain things done. There are two parallel tracks:
- The N=1 studies that are outside the regulatory process, just people experimenting on themselves. There is no need for (investigational trial) approval or mass use. That’s going on, and it’s the #WeAreNotWaiting side of this. The plan is to start collecting individual data and putting that together to show it’s safe.
- Then there’s the traditional clinical trial vision, to find and start talking to people with experience getting FDA approval for those studies.
It seems this is a critical moment when many of these developments are “coming out of the closet,” so to speak…
Dana) That we are being open and transparent, I think, does help companies and others who are in stealth mode. And it gives people with diabetes to hope that it’s coming.
Scott) It’s exciting to see so many who’ve been doing this, but haven’t been comfortable sharing until now. That’s big. The speed at which Nightscout is running, makes all of this move ahead more quickly. It’s interesting to see those efforts come out into the open.
How can we all help?
Dana) The big thing I hear all the time is, “I want it!” and then the question of how they can get it. Sign up for the OpenAPS mailing list, and you can find all kinds of information there online including any announcements we make.
Everyone’s a part of this. It takes all kinds of people with different skills and knowledge, and just being willing to share stories. Recently, someone saw a typo appearing on the Nightscout screen, and he opened up the tracking document online and put a bug report in to get it fixed. That involved Github (development environment), and it was very straightforward to make the change himself even with a small learning curve. So just proofreading is important, and just spreading word and talking about it. There’s something everyone can do.
This is such great news, both on the #OpenAPS front and about that big wedding coming up! We wish huge success on both fronts!