Insulin monitoring is going cellular. Cellnovo, a U.K. 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, CEO 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 packetizes the data and transmits it to a secure back-end over a GSM radio.
On the handset, a blood glucose monitor with a GSM radio connects to Cellnovo Online, the company's cloud-based clinical management platform. The mobile handset regulates how much insulin the pump delivers to the patient.
"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 centers 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 U.S. 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.