It's happening, Folks: Dexcom has officially stepped beyond just continuous glucose monitoring with data-sharing to become an active purveyor of closed loop technology that will automate insulin delivery.

The highly successful California CGM company on Aug. 22 announced the acquisition of Virginia-based startup TypeZero Technologies, founded in 2015 as a spin-off of University of Virginia closed loop technology research. TypeZero is developing what it calls the InControl system (formerly named the DiA, or Diabetes Assistance), a control algorithm run on a smartphone app that communicates with an insulin pump and CGM to automatically adjust basal and bolus insulin as needed when a hypo or high blood sugar is predicted.

By making this acquisition, Dexcom becomes a full-fledged player in the race to create an Artificial Pancreas system, rather than simply a provider of one key component (CGM). 

 

A "Plug-and-Play" Diabetes Closed Loop System

One of the major advantages of this system is that from the start it's been designed to be pump and CGM "agnostic," meaning it wouldn't lock users into any specific product brand. Dexcom confirms that it will continue in this vein, and will not be pushing a Dexcom CGM or any particular pump model to eventual customers of this system.

Instead, they imagine a world of "plug-and-play" diabetes tech -- where you can choose devices and tools that work best for you, instead of being locked into one CGM, pump or smart pen, or any pre-packaged set of products. Now, Dexcom will just happen to own one of the algorithms.

"This creates just the opposite of locking people in, it opens up so much opportunity," says JDRF Chief Mission Officer Aaron Kowalski, who's been a leader in ushering in Artificial Pancreas development for more than a decade now. "You're going to see more options."

With this latest news, Dexcom and TypeZero say they'll have a first-gen InControl system in 2019 -- utlizing a Tandem t:slim X2 insulin pump, since that company has partnered with TypeZero since 2016 in developing a configuration dubbed the Control-IQ. It can automatically shut off insulin when a low is predicted, as well as auto-adjust with boluses to bring down high blood sugars. That's a step beyond the Basal-IQ system that Tandem just recently launched in August 2018, and Tandem has confirmed launch plans for its hybrid closed loop with the InControl algorithm in early 2019.

 

Impact of the Dexcom-TypeZero Acquisition

TypeZero execs unsurprisingly referred questions to the new parent company. There we spoke with Dexcom's VP of Corporate Development Matt Dolan, who tells us TypeZero's current location in Charlottesville, VA, will stay intact and become Dexcom's first in-house R&D group in that state. The team is already quite familiar with Dexcom CGM tech and that "will help us accelerate a number of important efforts in our product pipeline," Dolan says.

When asked about the timing of this acquisition, Dolan said: With FDA's approval earlier this year of the Dexcom G6 as a first-of-its-kind with "iCGM" designation, allowing for the G6 to be used with other connected D-tech more easily, this TypeZero acquisition "fits right into our broader strategy and drive toward interoperability."

We also asked whether this might be Dexcom's first step toward buying an insulin pump company (like Tandem), in order to eventually develop its own proprietary Automated Insulin Delivery system?

"No, this is not a signal that we are entering the pump space. This provides an opportunity to bring more options to both insulin delivery partners and patients, including AID algorithms as well as decision support tools," Dolan says.

"We will continue to support partnerships with the same level of commitment we have had to date, and we don’t have a bias toward our AID algorithm. The goal of our open platform is to commercialize many great options to manage diabetes, which is in the best interest of patients."

 

The Diabetes Tech Industry Responds

When it comes to developing advanced diabetes tools, you almost need a family tree chart to keep track of who's teamed up with who these days, and it's constantly evolving.

Over the past few years, TypeZero has partnered Dexcom and Tandem; with Cellnovo on a version using that hybrid patch pump; with Senseonics using their implantable Eversense CGM; and with the EOFLow patch pump in Asia.

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Meanwhile, Dexcom has partnered with AID system developers like Beta Bionics for the iLet; with Eli Lilly and Novo and Sanofi on their future D-tech; and with Insulet on the OmniPod Horizon closed loop system that will use the algorithm being developing by Bay Area startup ModeAGC.

So what do all these other players think about Dexcom's move to acquire TypeZero? We reached out to a number of them for reactions:

Tandem: "The terms of our agreement with TypeZero are not impacted by the Dexcom acquisition and we look forward to continue working with them," spokesman Steve Sabicer said. "Dexcom’s acquisition of TypeZero has no impact on the terms of our existing agreements with either company."

Insulet / OmniPod: "This news will not impact our relationship with Dexcom or any of the projects we are working on with them," said Natalie Montgomery, Insulet's marketing manager for global PR and field programs. 

Bigfoot Biomedical: The startup's president Bryan Mazlish says, "Bigfoot has been advocating for closer integration of diabetes technologies into systems for many years and we're excited to see Dexcom and TypeZero moving in this direction. We believe systems, such as what we are developing here at Bigfoot, are the future of diabetes technology and will best serve patients and providers in the years to come."

Beta Bionics: "“Beta Bionics is excited for Dexcom’s ongoing commercial success with G6 setting the iCGM standard. We are extremely proud to have a close and longstanding partnership with Dexcom," says VP of Business Development Ed Raskin. "Dexcom has confirmed to us and in public comment that it has no intention of competing directly with the Beta Bionics iLet bionic pancreas system, or any of Dexcom’s other insulin pump partners. We also do not see the TypeZero algorithm as competitive with the Beta Bionics approach to automated glucose control.”

Cellnovo: "This is big news for the industry and we see it as a positive development for our current partnership with TypeZero," says Cellnovo's Communications and Digital Marketing Director Bommy Lee. "As a reminder, we signed a commercial agreement with TypeZero in April 2017 to integrate their InControl algorithm into our automated insulin delivery system, which is now set for an initial clinical trial in Europe."

Senseonics: "Integrated automated insulin delivery systems are an important development for people with diabetes, which is why Senseonics is pleased to have partnered with TypeZero Technologies on the NIH-funded IDCL program and, more recently, with Beta Bionics on its own artificial pancreas program," said Mirasol Panlilio, VP and general manager of global commercial at Senseonics. "As (this) acquisition announcement is very recent news, Senseonics is working through the details with the companies to determine how this new development will affect the TypeZero licensing agreement moving forward."

And don't forget: Medtronic has acquired an algorithm from Israeli startup DreaMed for its future fully closed loop systems in the pipeline, while Abbott has partnered with Bigfoot in using a future-generation of the Libre Flash monitoring system in Bigfoot's system. The Big Three insulin makers Lilly, Novo and Sanofi also have their eyes on AID systems, as well a number of smaller new CGM developers gunning to get their new products to market.

It's also important to note that with all of these algorithm-agreements, not all are going to turn out the same way. Each company buys the right to use and further develop that basic algorithm, meaning by the time a product actually gets to market it won't be the exact same TypeZero algorithm as what was purchased. Think of it like buying a house: You buy the basic model, but each one varies with different looks, appliances, doors and cabinet knobs. That's how the APs will evolve, too.

As the saying goes in so many things diabetes medtech, "the race is on"...

 

High Praise from JDRF

Kowalski at the JDRF, a fellow T1D himself who's had his finger on the pulse of this closed loop and AID universe for years now, has high praise for this latest development. He points out JDRF has funded TypeZero's research from its early days at UVA.

“Having a vehicle to get the technology from these algorithm research groups out to people has been a challenge over the years. But now only recently, we’re starting to see the technology getting to the commercial space. To see TypeZero get picked up by Dexcom is great,” he says.

Keeping in touch with PWDs involved in the TypeZero-Tandem clinical trials, Kowalski says he’s heard that system described as “off-the-charts good” and “life-changing.”

He's also excited about seeing Dexcom lay more ground work for a “plug-and-play” world, where PWDs can mix and match various devices and tools.

“What if you could just plug in algorithms with whatever pump or CGM you’re using?” he mused. “Dexcom has the ability to potentially talk to so many different pumps or smart pens, and algorithms that can be plugged in… wow! That’s the difference here. We’re seeing it... opening up a lot of interesting possibilities.”

So overall, this acquisition is looking like a very good thing for all parties involved.

Many agree it's a brilliant move on Dexcom's part, positioning them to be leaders in future connected systems, beyond just creating the world's most popular CGM.

Will they eventually take the next step and get into the insulin pump business? That's a lot more expensive and risky of course.

We're just delighted that for now, the focus is getting reliable automated systems into the hands of as many people with diabetes as possible, as soon as possible. We thank them for that.