U.K. mobile device vendor Cellnovo has developed a way to connect a diabetes pump to a mobile monitoring system to send real-time data in the cloud to physicians.
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.
Brian T. Horowitz is a freelance technology and health writer as well as a copy editor. Brian has worked on the tech beat since 1996 and covered health care IT and rugged mobile computing for eWEEK since 2010. He has contributed to more than 20 publications, including Computer Shopper, Fast Company, FOXNews.com, More, NYSE Magazine, Parents, ScientificAmerican.com, USA Weekend and Womansday.com, as well as other consumer and trade publications. Brian holds a B.A. from Hofstra University in New York.