By: Cory Schultz and Satish Misra, MD
People living with diabetes have a new mobile tool to aid with managing their disease. Recently, Cellnovo announced CE Mark approval for its mobile diabetes management system, a significant milestone for the company.
For those who do not know, CE Mark approval is a big deal. It is an acronym for the French “Conformite Europeenne” and certifies that a product has met EU health, safety, and environmental requirements.
It is similar to getting FDA approval for a medical device in the United States. Manufacturers in the EU and abroad must meet CE marking requirements on certain products in order to market their products in Europe. While there isn’t a comprehensive list of products that require CE marking, certain medical devices like Cellnovo’s product do. So, much as WellDoc’s 510k approval from the FDA for is diabetes management system was a big deal, this announcement shows us that the trend is just as strong across the pond.
“This is Cellnovo’s first step in a journey to bring this mobile diabetes management system to the world,” says William McKeon, Chief Executive Officer of Cellnovo. “
Cellnovo has built a pretty impressive mobile platform for diabetes management. The system includes an insulin patch pump, a wireless touch-screen handset with built-in blood glucose monitor, and an extendable applications set. In fact, the patch pump is one of the smallest, if not the smallest, available on the market.
“Cellnovo has created the first insulin pump that brings innovation and combines form with function, essential qualities in a device that patients have to interact with 24/7,” says Dr. Pratik Choudhary, Clinical Lecturer in Diabetes at King’s College London.”
Insulin patch-pumps first hit the market in 2005 with Omnipod – these small devices are the size of a matchbox car, adhere to the skin, and their functionality is managed wirelessly with (typically proprietary) handheld devices. These handsets generally, as in the case of the Omnipod, have traditional blood glucose monitor functionality as well. However, these systems can also be paired with continuous blood glucose monitoring services like that offered by Dexcom.
Cellnovo, and others, have additionally made the leap to providing telehealth services as well. The Cellnovo handset is able to receive and transmit real-time data to a secure web portal for patients and caregivers to use. For diabetic patients, the implications are great. No longer will they have to keep precise, tedious journal logs, since the data collected by the handset is consistent and very accurate. Furthermore, centralized data storage could also allow for automated flagging say if a patient were not checking their blood sugar or if their fasting blood sugar was trending a bit low or high.
Then there is the question of the artificial pancreas, automating the delivery of insulin based on continuous blood glucose monitoring. While it will certainly not be as good as a real pancreas given the numerous other factors involved in self-regulation of glucose levels, it would be a huge leap forward. However, despite decades of research we are still waiting for this. Why? Because these systems remove the intermediary between data collection (blood glucose checks) and an intervention with potentially fatal consequences (insulin delivery). As such, even though these systems are in development and showing promise across the country, they must clear some pretty extraordinary regulatory hurdles to prove their safety.
“The ability to see real-time data of patients who may be hundreds of miles away provides the opportunity to redefine our care model,” says Dr. Mark Evans, Lecturer and Honorary Consultant at the Institute of Metabolic Science at the University of Cambridge.”