Recently I stumbled upon a firm based in Fort Lauderdale, FL, that calls itself Pancreum, "The Wearable Artificial Pancreas Company." Wow. Really? There is such a thing already? I just had to investigate.
The company's website describes a four-part system including a controller (PDA), a CGM sensor called the "GlucoWedge," a small wireless insulin pump called the "BetaWedge," a small wireless glucagon pump called the "AlphaWedge," and a set of "iPancreum" software apps that manage these components and allow for storing and graphing data results. This seems like an incredibly ambitious undertaking for a tiny unknown outfit.
The first thing I did was ping Aaron Kowalski, who heads up JDRF's Artificial Pancreas Project, but he had never heard of this company, so that put me off a bit. Is Pancreum for real?
Turns out that Pancreum's Co-Founder Gil DePaula not only has decades of experience in software engineering and a stint at Medtronic Diabetes working on the Guardian RT system under his belt, but also spent 5 years at Insulet Corp., where he worked together with Marc Anderson, JDRF's Manager of New Technology. Pancreum is currently made up of Gil and a handful of contractors.
I had a call with Gil last week to learn more about the company, which also boasts on the website that users will be able to control the Pancreum system directly from "your own hand-held iPod Touch, iPhone, iPad, Windows Mobile SmartPhone, BlackBerry, Palm or Linux devices."
"We are creating all three wearable devices that make up an artificial pancreas (plus) the handheld controller, which is mainly software and can be run from a PDA or smartphone. The three wearable items are an insulin pump, continuous glucose monitor, and glucagon pump — which is different from what others are doing because there's no commercial 'predicate device' yet for glucagon delivery," Gil says.
"Our system will physically look different than anything you've seen before, and will be configurable in a way that you can use the pieces separately. You can mix and match the three components based on your preferences. The controller will automatically recognize whether you're wearing the CGM and insulin pump only, or the insulin pump and glucagon pump, etc."
"All three devices together will take the space of maybe two OmniPods at the most," Gil adds. "Obviously they can't be next to each other on the body. Think of a circle (or disk) with the diameter of two pods. Three devices will lie on the outside of the circle, at the three points furthest apart, say 4 inches from each other. Our system is going to be flexible, not solid, for comfort and wearability. There's a key technology element that makes all of this possible, but I can't disclose that yet because the patent is not yet ready."
Does the word "Wedge" in the product names imply some sort of triangle shape? Gil doesn't deny this, but says he can't elaborate just yet. He also can't yet share any sketches or visuals other than the "guts" above - darn!
What he does talk about are other big advantages of this enterprising project: lower cost than competing pumps and CGMs, and the ability to use this system "plug-and-play" style with other products on the market. Interoperable diabetes components at last? No way!
Yes, he says, Pancreum hopes to provide an open platform of specs that other companies can develop to, allowing interoperability. In other words, the Pancreum PDA would be able to control your own "custom artificial pancreas" that might be made up of the OmniPod and a Minimed CGMS, along with a glucagon pump from a third provider. The Pancreum algorithm will be the "gatekeeper" that controls all three.
Gil has applied for several patents, and is currently stumping for venture capitalist funding, he tells me. He's in the process of creating working prototypes now, but has made a conscious decision not to approach JDRF until the company is funded and further along. "If you present just an idea, it's worth X. If you have a prototype, it's maybe worth 3X. And if you can show more, it's worth 10X," he explains.
They're planning to roll out the components one at a time, starting with the CGM. "We need to sell that to investors first," Gil says.
Even if Pancreum gets the funding it needs this year, it will be another 2-3 years down the road before anything would be ready for market.
That's not surprising. But what about getting past the FDA with a system that can automatically shut off insulin delivery, reduce it, or initiate glucagon delivery? (With the glucagon pump, you won't have to rely on temp basals to decrease insulin delivery when you go low!)
"With the FDA, when everything is automatic, they fear software bugs. And so do we. We're human," Gil says. "They don't like the automatic shut-off, but we believe that with the glucagon pump portion, it changes things. It can raise your glucose level fast and efficiently. Sure, if your glucose level is raised to 250, you'll maybe get upset. But it's better than plunging down to 20."
Other companies, like Medtronic, are also working on commercializing glucagon pumps, Gil says. What will they look like? Possibly very much like insulin patch pumps. But the cannula may differ greatly. "It depends on the viscosity and corrosion of each liquid," Gil says. If you say so.
If you're like me, you'll find this stuff exciting. Just make it work, Engineers and Medical Experts — oh pleeeeaaaase! I realize it can be hard to hear about early-stage companies whose innovations are still far off. But think of the alternative... And with that I say: Thank you, Gil.
Note: You can follow the company on twitter here - @Pancreum