Cellnovo, a UK mobile medical device vendor, has developed a system to transfer data from a wirelessly connected insulin pump to a cloud-based cellular system in real time.
An insulin pump, attached to the body with Velcro, connects wirelessly to a touch-screen activity monitor that resembles an Apple iPhone but doesn’t make calls. Cellnovo has disabled the voice capabilities of the mobile monitor as a safety feature. This allows an uninterrupted flow of insulin from the pump to the patient, William F. McKeon, chief executive of Cellnovo, told eWEEK.
The Cellnovo system uses ANT ultra-low-power wireless sensor technology from Garmin International’s Dynastream Innovations unit.
“Ultra-low-power radios keep the pump and the handset constantly in communication,” said McKeon. The handset packetises the data and transmits it to a secure back-end over a GSM radio.
“We have many sensors on the pump that measure the temperature of the insulin,” said McKeon. “All of that information is constantly being communicated to the handset, and once that information is on the handset, that information gets moved up over the mobile network.”
By wearing the pump as a patch, patients don’t have to keep a journal, according to Cellnovo.
Cellnovo is conducting trials with 100 type 1 diabetes patients in 10 leading diabetes centres in the United Kingdom to determine how connecting a wireless insulin pump to a wireless data-transfer system will help them regulate their diet and take the proper amount of insulin. The usability trial allows patients to share data and caregivers to evaluate it remotely in real time.
Through the trial, scientists hope to find ways to improve care for diabetes patients and make diabetes care more cost-efficient, said Greene.
Professor John Pickup of King’s College London School of Medicine is the principal investigator for the trial.
“The Cellnovo system provides us immediate access to the clinical status of all our patients on a single screen,” trialist Stephen Greene, a professor at the University of Dundee, said in a statement.
The Cellnovo diabetes management system is part of a remote-monitoring trend in health care, according to McKeon. Mobile technology will become embedded in medical devices on a regular basis, he predicted.
However, McKeon believes that eventually the device will matter less and the real value is with the cloud-based platform. In a way, it mirrors how the iPod became less important as Apple’s iTunes moved toward a more cloud-based model.
“That’s the real seismic shift, moving from MP3 players to iTunes,” said McKeon. “The device has become less important. What’s most important is in the cloud, and it’s the same way with managing a patient.”
Instead of patients traveling to a clinic for a consultation with doctors on their conditions, wireless radios will bring more immediate connectivity, he suggested.
“In five years when we’re talking about medical devices, people are going to look back to when patients would drive to a diabetes clinic or cardiovascular clinic four to 10 times a year when a [wireless] radio could have done that for us,” McKeon explained.
Although 96 percent of diabetes patients in the United Kingdom inject insulin themselves, 20 to 25 percent of patients in a large part of Europe and North America use pump technology, according to Cellnovo. The company aims for its cellular touch-screen system to ease adoption of insulin pump therapy and simplify care of diabetes patients.
Following trials in the United Kingdom, Cellnovo will show the diabetes management throughout Europe and then seek 510(k) clearance with the US Food and Drug Administration to try to begin selling the device by midyear in the States, said McKeon.
Section 510(k) of the Food, Drug and Cosmetic Act mandates that medical device manufacturers notify the FDA at least 90 days in advance before bringing a product to market. The vendor must demonstrate to the FDA that the product is safe to get clearance.
With the real-time data provided to doctors, McKeon hopes that more diabetes patients will be able to avoid losing limbs and eyesight. By using software to record blood sugar and diet numbers and by connecting to cellular radios to transmit the data, people could possibly live longer and healthier “without the burden of this disease”, he said.
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It makes no difference what devices are used to record and control diabetes it's still going to kill you in the end that's a guranteed fact
Cellnovo are doing a lot of great stuff but really, the CEO has been confused in his thinking from the beginning. His comparison to Apple is rather shallow and ill considered. These two markets are so different to each other. The reality is that Apple took time to understand the market in which they were operating and moved to create a product offering that met those needs. In the process they created a great product that triggered a paradigm shift in their market. Blindly copying that product format, and hoping for similar success, is a folly. One key difference is that Cellnovo will, hopefully, be selling products to cash strapped healthcare providers, to pass onto patients that do not really want these products, because what the patient really wants is to be free of diabetes. Moving data to the cloud and sharing it has never been the challenge in the medical device arena. Almost everyone does it with BG readings. The real value lies in what you do with the data. And this does not mean how closely you can copy Apple's visual format, but how you use the connectivity to deal with the day-to-day issues that your customers have. Cellnovo appear very light in this respect. By claiming that the device will matter less in the future, Mr. McKeon further demonstrates his naivety. For Cellnovo, as for most medical device companies, the device is everything. The device delivers the insulin. The device measures blood glucose. They keep the patient alive. The IPod was not so critically positioned. The reality is that the cloud will never diminish the importance of the insulin pump and BG meter. The cloud may offer some added value but only once its role is properly understood. If Apple were in this space, this is what they would focussing on. One thing Cellnovo has done well is understood that patients are still customers and their products have a great consumer feel about them. But, the question is whether the company could have achieved the same product appeal while avoiding the obvious risk that the product may end up being too expensive. Another is, will the product justify the £37 million spent on it to-date.