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.”
The "guts" of ambitious new AP technology (on Gil's granite countertop?)
“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.
Gil's a member of TuDiabetes
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
Awesome awesome awesome!!! Finally! I love hearing about these things from you. 2 -3 years isn’t that far off considering… well considering.
Hi, Amy
I’m Mauro…
I have been working for “Zero” and for “Zero Android Interface” I would like to collaborate with Mr. De Paula for his Project, If he wants I’ll help him on his Amazing Idea!
..W la innovation…
Thanks so much for bringing us more information about this Amy. I have seen it in the past, but the info available is so thin and I’ve been curious. You and Gil have filled in some of the blanks.
good luck! I like his goal to integrate with everyday devices and to incorporate glucagon. I thought a big problem with glucagon, though, was that it is not stable in liq form for very long?
I find this very exciting, too. Thanks for posting about it.
This sounds like a great idea that might benefit from cooperation with other teams/companies working on similar concepts. I do hope that Gil makes the component interfaces open, so others can build on what Pancreum has available at any point.
I’d love to see JDRF AP team define the hardware and software interfaces that must be used between glucose sensors, insulin and glucagon delivery devices. If they did this, then there’s a good chance that an AP user could choose a sensor device from company A and insulin/glucagon devices from company B.
Wow. This is very interesting, Amy. Great reporting, and thank you so much for sharing this with us (not to mention Dr. Kowalski!).
Interesting, but 2-3 years seems overly optomistic with a minimally funded company and small staff. Even larger entities working on single components of his overall system typically need that length of time to get throgh prototype design, to clinical trials, to FDA approval, let alone time to get the communities attention for a product launch. Good luck though!!
A glucagon pump! How great! I love the innovation in the diabetes community — so inspiring! Such a clue for us all to do something great with the cards we have been dealt! I’m already hoping that my kids are inspired to do something great in the diabetes community while growing up with a diabetic brother (their all under 10 — but I’m sure their brains are already thinking!)
WOW! So inspiring to see where technology is headed!
WOW thank you for sharing I love to see what is out there on the horizon for D technology. Keep up the great work guys!!
Hi mcityrk,
As Amy mentioned, the 2-3 years time frame only applies once the company gets fully funded and fully staffed.
Regards,
Gil
As a diabetic your posting is very informative and the pump has been something I always push off as a type 1 diabetic. Now that I’m in my 50′s an alternative may be in my future.
“Interoperable diabetes components”
“open platform of specs”
That alone would be awesome. There is just so much exciting stuff he is talking about. I hope he at least provokes better work from the other players in the electronic diabetes management market.
How about a 4th component that measures activity and adjusts basel rates according to activity level.
Is the algorithm self adjusting, customizing to the individual – such as with using a neural net kind of protocol?
Sounds wonderful but with this administration’s FDA approval process I think I won’t even see such a thing happen in my lifetime. Can you say disappointed and angry?
Hi Ted,
Thank you for your input. A 4th component is probably not needed because activity level is usually detected when (and how fast) the glucose level is dropping (measured via the CGM, and maybe a requested BG meter reading to confirm). At that point the basal rate for both insulin and glucagon would be adjusted.
Yes, the algorithm will be a “smart”/”learning” one, using several neural network principles. Whether it will autmatically adjust basal rates without human interference or not, will depend on its accuracy and FDA approval.
Regards,
Gil
Hi Laura,
The development cycle and FDA approval process (for this administration or previous ones) will not take so many years. Stay in touch and you might have a nice surprise in just a few years.
Cheers,
Gil
This sounds wonderful. I’m not a diabetic but my son was. His bs bottomed out during the night and I found him the next day. He had been dead for hours. Nothing I could do for him when I found him. He was 15…2 weeks before his 16th birthday. I would love for something like this to be on the market. No parent should find their child like I did. Having a device that could automatically adjust bs would be flipping awesome!!!!!!! Love it Love it Love it
Hi Lorie,
I’m SO sorry for your loss.
Sincerely,
Gil
I think your device is awesome, but….. Am I reading correctly, that you would need to wear a cgms, an insulin pump AND a glucagon pump? That is three devices! I’m sure our teen would not agree to wear it, unless two of the devices were implantable. Two Omni pod devices? Maybe if you can miniaturze and make those devices very small…. We want noninvasive technology. And i believe we are not alone in our thinking. I still cannot fathom why the insulin pump has to be the size that it is.
Hi Julia,
Thank you for the nice complement as well as for the very important input on the size and number of devices.
We’re working very hard at making everything as small as technology permits!
Does your teen currently wear a pod and a CGM? At this point in time I can assure you that ALL devices in the Pancreum Genesis Artificial Pancreas System will take roughly the same real-estate as an OmniPod pod + Medtronic Guardian REAL-Time CGM, for example.
As far as the number of devices: Unfortunately for a REAL artificial pancreas a CGM, an insulin pump and a 2nd pump for a substance that brings the BG level up (such as glucagon) are needed. But we’re trying to make it simpler and/or more affordable.
Also, there’s no need to use all 3 devices. You can pick and choose among them and the PDA software will configure itself automatically for whatever your choice was, for example, just the insulin pump!
Thank you again for your input!
I wish you and your teen the very best!
Regards,
Gil
How about pancreatic cancer? Is this something that could be used for those of us with pc?
that s great, but when it will be available for everybody all over the world????
It depends on the V.C. funding we’re negotiating, as well as the FDA/CE/etc. We think that, once properly funded/staffed, we can finish the design, do all clinical studies, and file with the FDA/CE/etc within 3 years. After that the ball will be on the feds’ side of the court…
Cheers,
Gil
Gil,
I have been dreaming and talking about this technology for years. The glucagon is the key to closing the loop! f I had the money, it would already be invested.
I want to sell it!
Hi MSIT1,
Thank you for the compliment on our future products.
Take care,
Gil