Ever since Insulet launched the Omnipod five years ago, the patch pump has been gaining steam as the must-have gadget for diabetes device companies. Many companies are in the works developing (or acquiring the technology to develop) their own, from market leaders Medtronic to newcomers like Debiotech with their Jewel pump. Now another company out of London, Cellnovo, is making its way on the scene, and getting some very hot press... but how good is their device really?
We spoke to Cellnovo's Chief Executive Officer, Bill McKeon, who's no stranger to diabetes devices and tools. He previously worked at Medtronic on their mobile initiatives. Cellnovo, a combination of "mobile cell" and "novo" for new, is both the name of the company and the name of their pump product, which is marketed as being smaller, thinner and supposedly better than any other patch pump on the market.
But to Bill, Cellnovo is not just another insulin pump. It's an entire "diabetes management system" built around the principles of mobile technology. Now to be clear, we're not talking about using your iPhone to manage your diabetes. Regulations aren't quite there yet. Cellnovo uses "the principles of wireless transmission of data," connecting a device to other devices or to the Internet, which is similar to how your iPhone or Blackberry works.
Like many others, the folks at Cellnovo realized that if you could share a patient's data, it would help physicians better understand their day-to-day life. It would also allow patients or caregivers to regularly see how the "big three" (blood sugar, insulin, exercise) affect their diabetes management. The hub of the Cellnovo system is the mobile handset, which not only acts as the blood sugar meter and controller for the insulin pump (like the Omnipod PDM, but smaller), but it also transmits the data to a centralized server, which then sends the data on to a web-based platform (akin to CareLink) or it can send the data via text message to a cell phone. The handset also features a food library, and the insulin pump includes an "accelerometer" that records when and for how long you were active. Insta-logging, neat!
Simple, easy and... pulsating?
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Although Cellnovo bills itself as an entire system, not just a single product, the pump itself is the first thing we consider when choosing pump therapy. How big is it going to be? Is it comfortable to wear?
Fortunately for us, Caroline Parker, a UK blogger at Diabetes Daily, has had a chance to touch and feel the system. She describes her impressions: "The pump itself really was tiny. The micro motors these guys were building were simply amazing. The entire unit was around half the thickness of the Animas pump I was wearing at the time and considerably smaller than the Omnipod dimensions."
The Cellnovo patch pump uses a Velcro-like adhesive strip to attach to the patient's body, so it is removable at any time. Although described as a "patch pump," there is some tubing involved. But it is much shorter than traditional tubed pumps, and in general meant for more flexibility.
It may seem strange, but the Cellnovo pump is a pulsatile pump. Unlike traditional insulin pumps which use a motor to push insulin out of an enormous barrel (from 180 to 300 units), the Cellnovo pump uses a "wax actuator," which takes insulin from the larger reservoir and moves it into a smaller chamber. Once the smaller chamber is sealed, the insulin is then delivered. This allows the pump to deliver insulin with a much higher precision. According to Bill, most insulin pumps actually deliver insulin with a plus or minus 20% accuracy rate because of a siphon effect, as reported in the January 2010 issue of the Journal of Diabetes Science and Technology. That means if you give yourself one unit of insulin, you could be getting as little as .75 units or as much as 1.25 units! The Cellnovo pump reportedly drops the error margin to a staggering plus or minus 1-2% rate.
Cellnovo's entire platform is clearly based on the principles of Apple technology. The iPhone and iTunes were repeatedly mentioned by Bill in our conversation, in reference to how "seamlessly easy" and intuitive the products are. The goal is to make Cellnovo as easy to use as an iPhone, and everything from their touch-screen handset to their packaging reflects an innovation and sophistication that is currently lacking in medical devices.
Blogger Caroline Parker also writes, "The most surprising thing though is how familiar that control device looks. It took me just a few moments to realize that bears more than a passing resemblance to a touch screen cell phone and most specifically an iPhone - even down to the 'slide to confirm bolus' action. And once I realized that, I couldn't help but think that maybe Amy Tenderich's Open Letter to Steve Jobs had been answered after all."
Bill explains the mindset behind it: "You don't want to be a PhD in pump therapy. You just want to live your life." (don't we know it!)
The mobile aspects of Cellnovo's technology will benefit many parents who struggle to manage their child's diabetes from a distance. For instance, if your child tests their blood sugar while away from home, you can send BG results automatically via text message. Although the "coolness of the technology" is a big appeal, Bill says the real aim is to "bring peace of mind to unburden patients."
Bill also hopes that the company's information hub, Cellnovo Online, helps providers and patients skip over the whole "so what have your blood sugars been lately?" step, because your doctor can see all your information in real-time. Physician adoption is of course TBD, because this system is still in the works, but the company apparently has had "many positive conversations with doctors."
One of my biggest beefs with diabetes medical devices is the huge amount of waste created. Although the Cellnovo pump still requires the usual set changes, etc., the pump itself is not a throw-away, more like a tubed pump that can be used over time. The throw-away items here are the infusion sets and the insulin reservoirs only. In addition, the pump is rechargeable. Cellnovo provides consumers with two patch pumps, one to use and one to recharge. Instead of constantly tossing out used batteries, this is one way we can reduce our carbon footprint.
Safety and Privacy
Anything mobile always gets me a little nervous... all my data floating between a mobile handset and cyberspace? Isn't that dangerous? Cellnovo gets that, so they use the exact same encryption service that international banks use to wire money around the world. Plus, Cellnovo meets all HIPPA requirements and never associates your data with your name. Privacy is guaranteed. According to Bill, that makes the FDA very comfortable with the idea of using this mobile technology.
The Big Bad FDA
So... how does the FDA feel about this newfangled gadget? After last week's drama with the still-delayed EnLite sensors, some people might be wondering if the Cellnovo insulin pump is just another pipe dream.
"They told us that it's the best user interface they've ever seen on a medical device," Bill shared. "We're proud of our relationship. We've listened to them."
Although FDA procedures are often a sticking point for PWDs, Bill sees it in another light: "Their job is to protect people. If companies are doing that usability testing ahead of time, we shouldn't blame the FDA. We should thank them for raising the bar higher. We're going to get better and safer products out there. That's great for the industry... The FDA is more progressive than people give them credit for. They have a tough job. They have to protect the community they serve. No one wants to read that someone was harmed or died by a product on their watch."
Cellnovo has worked closely with their team at the FDA, which has given feedback and advice on what they will require of the company, and says it's crucial for medical device companies to have even higher standards for their devices than the FDA does.
It's hard to get your hopes up when you're terrified they'll be dashed by your dumb insurance company, but Bill explained that the Cellnovo insulin pump is actually cheaper for payers. Like the Omnipod, which has a much lower upfront cost than tubed pumps, Cellnovo is confident that insurance companies will support their system.
The low upfront cost for Cellnovo "would be a fraction of what you would be paying when moving onto a conventional system," Bill says. Although he couldn't give us specific pricing figures, he claims that over the four years of a typical pump lifespan (when the warranty ends), the Cellnovo pump will cost payers less than both a traditional tubed pump and less than the Omnipod.
So where are they now?
The Cellnovo insulin pump is gearing up to launch in Europe, led by the same guy who led Novo Nordisk's production of insulin pens. Cellnovo has actually been prepping and manufacturing for a couple years now, so they are ready to meet the demand.
Alas, that demand in the US may have to wait a little while longer. Cellnovo will apply for 510K status with the FDA and begin clinical trials in the fall, but there is no guarantee when they might appear on the US market. Bill refused to even wager a guess, saying he'd much rather be conservative and wrong than over-promise and not deliver (a common theme we're hearing these days...).
In addition, they are working on several partnerships with blood glucose meter and CGM manufacturers, but still nothing's approved. Bill was tight-lipped about what this integration could look like...
Which of course brings us back to the recurring frustration over new technology we want, but can't yet have. We get that. Cellnovo might not be something you should hold your breath for, but it certainly is an exciting prospect! And hearing a CEO talk about life with diabetes and really getting it is nice.
OK, it doesn't take away the pain of this disease in the present, but it is nice to know that the devices on the horizon aren't just the same-old, same-old with a new name. Some people really are trying to revolutionize how we manage this damn disease.