The global battle against diabetes is on. Evident signs of the massive focus on the disease can be seen in the wide number of products coming to market to help manage diabetes. Ventures such as Medtronic concentrate on developing an artificial pancreas. Also called a closed-loop system, the artificial pancreas continuously monitors blood glucose levels and automatically deliver the proper amounts of insulin as needed. A host of other companies tackle less challenging but significant single-purpose aspects of managing the disease, especially focusing on blood glucose testing, a necessary and vital task that must be performed multiple times a day for most diabetics.
Integrity Applications’ GlucoTrack is a non-invasive glucose level monitoring device for adults with prediabetes and Type II diabetes (T2D). Rather than checking blood from a finger stick, patients use an ear-clip attached for a few seconds to the ear lobe. The clip uses three technologies simultaneously for accuracy: ultrasonic, electromagnetic, and thermal. The ear clip plugs into a proprietary handheld reader that looks similar to a smartphone with a color touch screen. On the handheld device, the three readings are combined to provide a weighted average glucose score by a proprietary algorithm. The battery-operated device has a USB port to download measurement data and to recharge the battery. The latest model, the DF-F, supports three users, each with their own calibration. Reading results are displayed on the screen and announced verbally. The device stores the last 1,000 readings.
The GlucoTrack Model DF-F is CE approved but no mention is made of seeking FDA clearance or approval for sale in the U.S. In addition to pain-free testing that appears to be simple and fast, the GlucoTrack also saves users the cost of test strips, although the clip needs to be replaced every six months. Anything that can simplify the often complex business for patients managing their diabetes is a win.
Where to find evidence of CE approval?
Please see our CE Mark Certification on our corporate website. http://www.integrity-app.com/about-us/certification-documents/
GlucoTrack® is in the pre-submission phase for FDA approval.