Integrity Applications, from Israel, has received CE Mark approval for its GlucoTrack DF-F non-invasive blood glucose measurement device. Non-invasive glucometry has been a goal pursued by many companies over the years, however few have succeeded. Some devices have received the CE mark, but none of them seem to be actively marketed at the moment. Hopefully, this one fares better in its quest to liberate diabetics from frequent needle pricks, while saving them the costs for test-strips in the long run.
The GlucoTrack DF-F consists of a small sensor that is clipped to the earlobe and connected to a smartphone-size, handheld control and display unit. The main problem with non-invasive blood glucose measurement is that few methods give accurate results under varying circumstances. To overcome this problem, the GlucoTrack employs a combination of three methods, utilizing ultrasound, electromagnetic, and thermal technologies to obtain blood glucose readings. Independent measurements are obtained using all three methods simultaneously during a one minute period. The results are then correlated and averaged using a proprietary algorithm. GlucoTrack can measure both spot and continuous glucose levels, with results displayed on a large LCD.
Re-calibration of the individual ear clip is required every month. Calibration is performed individually against invasive basal and postprandial capillary fingertip glucose measurements. Although the company says the calibration process is very simple, it takes quite a while, about 1.5 hours, and while it can be done at home it is recommended that it be done at the clinic. The main unit can be shared by up to three patients, although each user requires a personal ear clip due to calibration differences. Also, although the GlucoTrack requires no disposables, the ear clip must be replaced every 6 months. A USB port is used for downloading data and to recharge the battery. The company expects to receive FDA approval next year.
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