Smart Meter, LLC has announced it has received 510(k) clearance from the U.S. FDA and CE Mark in Europe to market the iGlucose Blood Glucose Monitoring System.
Aimed at improving health outcomes for people with diabetes, the iGlucose System is the first subscription-free glucose meter and diabetes health management system to offer automatic transmission of diabetes information to a cloud-based personalised web portal, while also facilitating simple, real-time mobile communication between the person with diabetes and those individuals in his or her designated Circle of Care.
The iGlucose System uses digital mobile phone technology known as Global System for Mobile communication (GSM) to facilitate two-way communication between an individual's iGlucose Meter and the iGlucose Web Portal.
Mobile health solutions, also known as mHealth, have been recognised to lower both cost and HbA1c, the key measure of an individual's blood glucose average. For the iGlucose System, GSM connectivity provides several benefits, including the following:
"While more than 400 million people have diabetes globally, managing it can be a lonely and frustrating journey for them if their healthcare professionals and loved ones aren't adequately involved in day-to-day care. Being digitally connected with their Circle of Care has proven to turn the tide for many people with diabetes," said Cliff McIntosh, CEO for Smart Meter, LLC.
"The web-connected glucose meters available today have shown limited results because they're so complicated to use. We're excited about our regulatory approvals because the iGlucose System's ease of use makes it possible for family, friends, and healthcare professionals to be truly engaged and support the person with diabetes in their daily diabetes management."
Different from other web-connected glucose meters, the iGlucose Meter comes ready, out-of-the-box, for communicating via the cloud. After a simple registration on the web portal using the meter's serial number and the user's diabetes information, the meter and web portals are set for continuous two-way interaction, with no additional steps required.
Communication to and from the web portal happens automatically with no cables to connect, no Bluetooth to synch, no wi-fi requirement, no uploads to remember, and no telecommunication specs to program. The person with diabetes only needs to check his or her blood glucose.
The meter and web portal handle the rest, communicating automatically in real time by way of a global IoT network. The iGlucose System's two-way communication is possible in more than 200 countries without any additional cost to patients and without the need for country-by-country IT integration or a specific brand of phone or mobile carrier.
While tracking a person's glucose results and diabetes information is one important function of the iGlucose Web Portal, the system also proactively initiates and manages multiple two-way communications between itself, the person with diabetes, and their desired Circle of Care designated during registration.
The portal integrates the person's diabetes data in easy-to-read charts, graphs and an e-diary to display at-a-glance trends. It also sends personalised diabetes tips, coaching suggestions, and reminders via system-generated texts and emails from the iGlucose Coach to the user, while also providing real-time alerts to their Circle of Care, informing them of glucose readings and other important information.
This makes it possible, for example, for a pharmacy to remind the user to refill test strips, or for a nurse or loved one to text encouraging notes or reminders that can help keep a person's diabetes management efforts on track.
Finally, with its web-based software powered by automated real-time data collection, the iGlucose System's cloud-based portal makes actionable health data available to healthcare professionals and payers. For instance, the software can identify "hot spots" in a physician's diabetes population to enable digital triage.
This now frees the physician to focus on the right patients at the right times based on what's revealed in their diabetes data, such as low or out-of-control glucose levels. For payers, the data collection capabilities of the web portal provide a cost-effective solution for accessing validated data on test strip usage, replenishment, and compliance, which helps improve health outcomes.
The iGlucose Blood Glucose Monitoring System uses just 0.75 µl of blood, features a five-second test time plus flagging of before- and after-meal results, and meets ISO 2013 standards in providing accurate blood glucose readings. In addition, the price of test strips and the meter will be equal to or less than the copays of leading brands.
Initial markets where the iGlucose System will be sold include the United States and the United Kingdom, with product expected to be commercially available in both markets sometime in 2017.