Remember that little circular, three-wedge closed-loop device known as Pancreum? You know, the Artificial Pancreas system in which you pop in wedges for insulin pumping, CGM (continuous glucose monitoring), and glucagon pumping, all around a little central core controller?
We've been watching the novel Pancreum system move forward since it won our innovation design contest in 2011, and although no advancements have been announced to the public, there's been a lot going on behind the scenes.
Now it's great to hear from Pancream founder Gil de Paula that his team has developed a working prototype of the potential multi-piece AP device. Novel medical devices always take a long time to develop, especially for small independent outfits that don't have the resources and deep pockets of Big Pharma. Since starting this whole venture, de Paula has moved the home base of Pancreum development from Florida to San Francisco, in part to be closer to tech talent and key contacts.
"We're not just a computer-generated image anymore, there's a real prototype behind it now," Gil told us in a recent phone chat. "People we've met with have been surprised and happy to see it's real, not just a concept."
In the past few years since Pancreum's concept came on the scene, a lot has changed -- from more advanced CGM tech, to increased mobile health and Bluetooth connectivity, to many advances in trial AP systems. Not to mention the advancement in stable glucagon formulas and all the AP studies that have been making headlines.
Pancreum's prototype, nicknamed Genesis, is making great headway, Gil tells us. "This isn't science fiction, and it's very doable within a reasonable time frame. Maybe there's one more design cycle and then we're looking to do animal trials."
Gil is now working on developing the CGM wedge with Oregon-based iSens, which has been working on a minimally invasive CGM sensor for the better part of two decades now. The company had been bought by Bayer years ago, but after the nation's financial crisis, that Big Pharma player opted not to market the iSens CGM sensor and sold the product rights back.
"Their sensor is great and we're forming a partnership with them," Gil said, adding that he's also interested in talking to any other CGM companies that might be interested.
His team has created an easy push-button insertion mechanism that allows you to simply put the device onto your skin and push the sides to make it click into place. And there's a push-button bolus delivery, something Insulet's OmniPod (the only full-featured patch pump on the market right now) does not have, meaning users have to go back to injections if they lose the OmniPod controller unit, called the Personal Diabetes Manager (PDM).
"In our case, you keep the pump on and there's push-button feedback via beeping that lets you navigate what you need," Gil said.
There's also a wireless mHealth component, of course. An iOS app's been developed with an appealing graphical user interface and next up is Bluetooth communication for that platform, as well as the integration of a blood glucose meter and the completion of the CGM wedge's electronic interface.
Long before the birth of the actual #WeAreNotWaiting movement, Gil himself wasn't waiting and had ideas that many in D-Community thought were a little far-fetched -- including open-source data integration. He's planned from the start to publish the protocols from his device and share that information with entities like Tidepool, which has been making strides in bringing D-data together.
"A lot of people questioned this in the beginning, asking whether it was realistic to talk about novel glucagon and smartphone apps with low-glucose suspend," Gil said. "Things change, and you could see it coming many years ago... Some of these predictions came true, and our own future has become more certain and realistic."
How soon could we see a Pancreum animal trial and eventually human trials for regulatory review? Probably not anytime soon; we're talking years here. Once again, these D-tech developments take time.
And so much depends on funding. Right now, Gil has been largely funding Pancreum on his own and from a few private donors, and that small group has spent roughly $200,000 so far. To earn more, Gil has been doing some side-work and tapping into his engineering experience on other cool tech that's been making news but has no diabetes connection.
Notably, he helped design the digital credit card replacement known as COIN, which was announced in November and is almost ready to hit the market. That credit card-sized device stores up to eight credit, debit, gift, or membership cards and lets you switch between them by pressing a circular button on its surface. From there, you just swipe the COIN in a card-reader just like you would with any traditional card.
Gil's also been working with Mechio Inc. in San Francisco to create a Bluetooth smartphone-enabled "stealth" wearable fitness device called Motiv, which would use health sensors to track fitness and movements and other health info like body temp and oxygen levels.
Those tech ventures help Gil fund what he's doing with Pancreum, and he makes a point to say his other work doesn't mean Pancreum development is slowing down or moving to the back-burner.
"It's cool to be involved in those other types of devices and tech, and it not only brings money to what we want to create with Pancreum but also helps us network with others in the industry," he said.
Aside from the Pancreum wedge system, Gil says he's working on another device that would be a stand-alone insulin delivery system, not too dissimiliar from OmniPod -- but that's in addition to his Genesis prototype and Gil isn't ready to share more on that publicly yet.
So will Pancreum become a real product soon? Not super-soon, for sure. But it's looking like a lot more than a pipedream, and we can't say enough how much we appreciate the work of people like Gil.