Those of us with type 1 diabetes appreciate the amazing insight that continuous glucose monitors offer on our blood sugar trends -- which can literally be a life-saver for those of us with broken pancreases.
But here's a question: what if general (non-diabetic) consumers could make good use of this same kind of health data through a very affordable new CGM sensor? And what if this new product also offered PWDs (people with diabetes) a new wearable sensor that's as accurate as those we have now but also offers something that's not been possible yet -- elimination of the need for fingerstick calibrations?
That's the vision of three Dexcom alums, who left the California CGM company last year to create their own tech startup called Glucovation and are working toward a goal that no one else has been able to accomplish yet.
Their vision is to create what Dexcom had planned from the start -- a sensor so accurate that fingerstick glucose tests would no longer be necessary -- but put on the back-burner in order to pursue more practical and near-term goals. Glucovation aims to create this ultra-accurate continuous glucose sensor that will last just as long as current models.
Sure, it's another lofty vision that prompts the "I'll believe to when I see it" response. But the guys behind Glucovation certainly have street cred, when it comes to diabetes devices.
As mentioned, the three startup executives are Dexcom alums. But not just any rank-and-file folk. There's Dr. Robert Boock, who was senior technical director of R&D at Dexcom and the main engineering mind behind development of the hailed G4 sensor, from concept to commercialization and beyond. His co-founders are Jeff Suri, Dexcom's former senior scientist with chemistry expertise, and Kenneth San Vincente, who was a senior engineer at Dexcom in charge of that company's smartphone integration initiatives and other projects.
On the Glucovation team of advisors is also Dr. John Burd, who actually founded Dexcom back in 1999 and led the company as CEO until the San Diego company went public in 2005. From there, he ventured into the non-invasive tech arena,but his company Oculir developing optical glucose monitoring tech didn't prove fruitful and closed in 2008. The reason, he tells us: "Unfortunately the mid-infrared signal that we hoped to use for the measurement could not make it through the tear layer and back to the detector. Because of this we closed Oculir in 2008 and returned the remaining funds to investors."
Of course it's a bummer the non-invasive tech didn't work out. But what Glucovation is doing isn't as far off the grid; they're simply continuing the work they started more than a decade ago, before CGMs became as common as they are now.
Honestly, if anyone can do it, this team really does inspire more confidence than many would.
So why did they all leave Dexcom? A number of reasons, Boock tells us.
"We understood that to make the next breakthrough, we had to break the tech down and take it to a basic level. That's tough to do at a bigger established company, because they like you to take incremental steps and improve on what's already there," he said. "We did the best we could with what we had there, and I think there's some low-hanging fruit that you're always focused on... another iteration that you can squeeze out for more performance. We realized that if we could get to a calibration-free system, that'd be a game-changer."
He goes on. "As the G4 creator myself, I know that to get to something calibration-free, you have to ... not just kind of milk the technology in order to recoup the investment, (but) change the tech and step out of that environment."
And so they did. In May 2013, the trio formed Glucovation (a clever play on "glucose" and "innovation") and began working on new sensor tech that would be called SugarSenz. Boock says he's excited to take continuous glucose-sensing tech into the consumer market, because this health data could be a valuable part of regular everyday fitness tracking even for those with a fully-functioning pancreas.
Why Target Consumers?
We were stuck on this question, too.
Watch this video from the company's crowdfunding campaign on Fundable, that describes how CGM will provide consumers a "real-time look into their metabolism" in order to gauge the effects of dieting and exercise:
While this might be considered competition to existing CGM-makers Dexcom and Medtronic, that's really not how Glucovation is looking at it. They see it as the first of its kind for the consumer market, and they're not even focusing on the medical world at this point.
To be clear, PWDs would also have access to this "consumer" CGM product — although the company does not plan to make any FDA filing, so it certainly wouldn't be FDA-approved for use in insulin dosing decisions, despite the improved accuracy. Boock tells us that down the road, they may explore partnerships or even licensing to big Pharma or an existing CGM device manufacturer to pursue the medical side more focused on PWD use.
Boock says his team has strong intellectual property around the novel electrochemical concept, in order to sidestep some of the factors that currently interfere with accuracy in existing CGM sensors and require calibrations. It's all about algorithms and changing the equation, he says. Traditional sensors have a lot of problems trying to filter through substances like uric acid in the body and other body chemical signals interfering with the sensor. But he says if you can change a simple part of the algorithm through electrochemistry, you can change how the sensor's powered and there wouldn't be any background signal, noise or interference. So, that means you can focus more on accuracy and aesthetics instead of constantly grappling with internal sensor issues.
"You're always playing the game of 'enough glucose to get a strong system, but not too much to create issues while minimizing interference.' It's a design optimization problem all the time," he said. "With our sensing tech that isn't enzymatic, we don't have to worry about oxygen and so the sensor can be more robust."
In a recent phone interview, Boock explained more details about the product Glucovation is developing. First off, there wouldn't be any separate device or receiver needed to view glucose data. Much like Dexcom is doing with its next-gen G5 that would communicate directly to a smartphone, the Glucovation SugarSenz would send data right to the cloud and allow for easy access on PCs, smartphones, etc. And that could-based data would be open, he points out, because really it's all about getting this health data into the hands of people and letting them use it however they want.
The SugarSenz sensor will be attached to your skin with peel-off adhesive backing and worn 7-10 days. But unlike current CGM sensors, the SugarSenz sensor is disposable. And the built-in "Transceiver" will last longer than the six months to a year that current Dexcom Transmitters do, because the "bulk" of it would be smaller, since the battery will be built into the disposal sensor part.
"To do this, you really have to know how to design a sensor... which we do," Boock said, and I could almost hear him grinning on the other end of the phone.
Simplifying the sensor applicator was also a huge priority for Glucovation, Boock says. He was never a fan of the bulky "squeeze and pull" applicator, which carried over from the original three-day sensor model and is still being used now with the G4. That device is a "mechanical engineer's dream since it has a lot of parts and so much going on with it," but it's a huge draw on the company's bottom line because it's so costly to make, he says.
Instead, Glucovation is targeting a 32-guage cannula that will have a shorter 6mm insertion depth and it'll be "self-inserting," requiring no separate insertion device.
"You would just lay this sensor down on your skin, push down and that's it," Boock says.
Because this is aimed at the mass consumer market, it won't be reimbursable by insurance, so Boock says they're zeroing in on an affordable price-point of around $150 for the device itself and $20 for each replacement sensor -- "it has to be affordable right out the door," he says. Wow!
CGM for All Soon?
Early alpha testing data looks promising, Boock says. The company's now working to fine-tune applicator designs, since the first wasn't anything more than a way to get the sensor into the body and it would never be sold commercially. They expect to start beta-testing by the end of summer, and will need that data and infrastructure to get to the next level of development. They don't know at this point exactly what accuracy stats might be, since that data is yet to come, Boock says.
Currently, they are crowdfunding and searching for investors -- as they're still early in the development processand at this point it's all about getting funding and footing in the wearable sensor market, Boock notes.
"We went to CES (huge Consumer Electronics Show) this year to try and see if the consumer space was a good play for us," Boock said. "We've heard that this seems to be something people are very hungry for — understanding what's happening with their blood sugar and the impact of every meal and exercise. And with such a huge number of people with type 2 and prediabetes, this could be a great tool for them to have."
Will it take off? Of course, Boock's experience as "Father of the G4" is impressive in itself, and he told us that he's of course very proud of what resulted from that total five years of G4 work. But now, it's time to move forward on tech sensing and go beyond just diabetes management, he says.
"This would be a huge jump forward," he said. "We think there's an exciting future, and we're all about trying to bring this to the consumer market."
** UPDATE June 11, 2014 **
Dexcom filed a state trade secrets lawsuit on June 6 against Glucovation and its founders, accusing them of conspiring to take proprietary and confidential CGM tech knowledge with them from Dexcom. The lawsuit alleges breach of contract and loyalty, misappropriation of trade secrets, and unfair competition. According to the 16-page suit asking for a jury trial, the founding trio left Dexcom suddenly in early 2013 but had been planning Glucovation since October 2012 and "misappropriated" their time while at Dexcom to develop the Glucovation concept. A jury trial is requested, and an initial motions hearing in San Diego Superior Court is set for Aug. 22. The case is Dexcom v. Glucovation, et al, case #37-2014-00018216.
The case remains pending, with the next-scheduled hearing set for January 2015.