Another new startup has its sights on creating the first commercial closed loop system, taking years of research on one of the country's leading Artificial Pancreas projects and using that as their own prototype to eventually sell to people with diabetes.
Please say hello to , a Charlotesville, VA-based startup that spun off from years of closed loop research and development of an AP system at the University of Virginia (UVA).
There are a number of similar projects underway across the globe, but UVA's School of Medicine calls their technology the DiAs (short for Diabetes Assistant system). Leading this research is , who heads up the university's and it's been tested through the years in both in-clinic and outpatient trials in Virginia, California, and Europe -- with at Stanford University and UVA's and all part of the sweeping research team.
And unlike with Bigfoot, which is still very new and in early development stages, we know a lot about the DiAs system from watching UVA's work over the past several years.
The DiAs runs a control algorithm on an Android smartphone that communicates with a Roche or Tandem insulin pump as well as a Dexcom G4 CGM. We're told the system is "pump agnostic" and they're working to bring two or three other pump models into the mix as well. There's a special Bluetooth box to connect to local data servers and the Cloud. The system is one that uses insulin only, without adding glucagon into the mix like the Bionic Pancreas project at Boston University does, with a dual-hormone approach.
In calculating blood sugar ranges, DiAs uses a "treat-to-range" approach during the day, where users are responsible for setting meal boluses, while the system works to keep glucose within a designated range using incremental increases or decreases in basal rates as needed. Overnight, the DiAs changes over to "treat-to-target," meaning the goal is to keep the user specifically at 110-120 mg/dL, the BG level at which they should wake up each morning.
Now, the DiAs tech has been licensed to the nine-person team at TypeZero to move it forward to commercialization. While the new startup hasn't been a secret, it's largely been under the radar awaiting its public launch in conjunction with the ADA Scientific Sessions starting this Friday.
Up until now, the device has had a "traffic light" look to it, with respective red and green circles indicating hypo and hyperglycemia, but the next version coming soon will sport a slick new look, we're told. And with that will come a new product name: the In Control system (ummm, OK).
Maybe you only want closed loop capability overnight, or to use the pump portion only while you take a break from the CGM. That adaptability is what the company plans to develop.
"The diabetes device burden is nasty, and that will keep some of these solutions from becoming a reality," says TypeZero CEO Chad Rogers. "We want to deliver this for everyone, make it adaptable, with software that can reside anywhere in the cloud, on a device or in a smartphone. This should be an affordable and accessible platform everyone wants and needs, and not limited to one device or platform."
Behind the TypeZero Name
The name TypeZero is pretty much derived from what you'd think: the desire to create a product that minimizes (or works to erase) the impact that diabetes has on our lives -- helping us not be defined by the disease or the tools and treatments we're using.
Those behind the new startup are largely affiliated with UVA and this research to date:
- Dr. Keith-Hynes, Founder & Chief Tech Officer, who worked at UVA’s Department of Psychiatry and Neurobehavioral Sciences and the Center for Diabetes Technology (CDT); he's actually the creator of the Diabetes Assistant (DiAs) Artificial Pancreas platform.
- The aforementioned Chad Rogers, Founder & CEO, with a background in startups spanning encryption software, medical devices and diagnostics, noise abstraction algorithms, interactive TV and consumer mobile devices.
- Dr. Boris Kovatchev, Founder & Chief Mathematician, founding director of the UVA Center for Diabetes Technology who's been leading the closed loop project at UVA.
- Dr. Stephen Patek, Founder, who works on this tech as a systems and information engineering genius at UVA.
- Dr. Marc Breton, Founder, an associate professor at UVA's School of Medicine who is also one of the engineering experts and a founding member of the Center for Diabetes Technology.
- Molly McElwee-Malloy, a registered nurse and certified diabetes educator (CDE), who's serving as TypeZero's head of patient engagement and director of marketing.
They tell us the startup was formed with three main goals in mind: taking the DiAs R&D into bigger trials; translating that into an app and software platform that also includes practical tools for patients like smart bolus calculators or advice and behavioral modifications; and developing an analytics platform allowing clinicians and payers to utilize device data.
R&D Plans, Target Users
Some large-scale clinical trial milestones are coming up in the next year, and the hope is to have this submitted for FDA review by the end of 2016! About $22 to $25 million has been spent on this DiAs research to date through the UVA work, and as of now the TypeZero team knows of another $5 million it will spend on the upcoming trials in the coming year.
While pilot studies are finishing up at six centers globally, two big ones are expected to begin in the next year -- including a $3 million study in September planned at UVA, Mt. Sinai in New York City, and at the Mayo Clinic in Rochester, MN, that's being referred to as "Project Nightlight."
Rogers says the plan is to submit that research to the FDA in early 2016 after its first six months of data are in.
From there, they'll look at pivotal trials to actually get a device to market. There's also an International Diabetes Closed Loop Trial planned to start next year that's been in the works for some time with FDA and industry collaboration, so that can be an avenue for TypeZero as well.
More than 300 people with type 1 have used the DiAs system globally in trials, but that doesn't mean this won't eventually be geared toward those with T2 diabetes as well, says McElwee-Malloy. In fact, that's a definite plan.
"We are also looking at the type 2 community, and don't want them to be ignored and left out of this solution either," she says. "They can really benefit from some of this technology, too."
The Closed Loop Race Is On
As we've noted, it's pretty much a race to get a closed loop system to market.
Interestingly, TypeZero may have the clearest and quickest path toward regulatory approval since they've already got two main hurdles taken care of -- an actual working prototype that's been field-tested in hundreds of people, and years of early clinical research already completed.
This stands in contrast to our friends at , who are basically using a largely untested homemade AP and have just now grabbed Asante Snap tech to weave into their design. TypeZero is not just working from a newly hatched idea, but rather building out an established university invention and hopefully fast-tracking it toward commercialization.
"We believe we have some truly dramatic things to bring to market shortly," McElwee-Malloy said. "This will make a huge difference for people. We don't want to over-promise, but hopefully the next year will be a dramatic one for closed loop tech."
Meanwhile, the race to the finish continues among all of the other AP designers out there -- from Medtronic's closed loop tech that will likely use the DreaMed algorithm, Animas and its Hypo-Hyper Minimizer, to the Bionic Pancreas and many other varieties being contemplated by academia and industry.
"We're in this for eight years now, and are well ahead of the game," Rogers says.
But TypeZero plans to collaborate with others, too, like pump manufacturers, app and analytics developers, and others. Some of those deals should be announced soon, we're told.
Would that include open-source closed loop systems, we wondered?
"It's hard to think open-source for AP systems," Rogers said. "In building your own solutions for monitoring or data display... it can make a lot of sense. But it's more difficult for closed loop and control algorithms, because of the untested protocols. Really, we're still learning how our system works with unique situations and differing scenarios as people live with the tech, and that's after 8 years. It's hard to take these do-it-yourself systems and make them available for general populations."
That seems to make sense, but hopefully the patient community can emphasize that cost and access are huge issues, and it's imperative to make these tools available to the masses. And also: we will want these future closed loop systems to be able to communicate in ways that don't lead us again to multiple "silos" of proprietary technology.
Hail to the researchers, device designers and business folk who are taking closed loop to the next level!