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GlucoTrack has a CE Mark in Europe, making it approved for use there. Integrity Applications is currently preparing for clinical studies in the U.S. Gal says that for all non-invasive glucose monitoring devices, calibration is the key factor. All devices need to be continually calibrated to get the correct readings because of the noise level.

“However," he noted, "competitive devices need to be recalibrated every day or every other day. In our case, the only time you need to recalibrate the device is when you use a new sensor, and then the calibration is valid for the entire life of the sensor. You don’t have to recalibration at all. And you only have to do initial calibration once a year when you replace the sensor unit.

“Our calibration process is very simple and can be easily done by everyone, but to ensure the total accuracy, we designated that calibration only be done by authorized clinics. It doesn’t need to be done by a doctor or even a nurse, because it it a very simple process. But, we decided that it should be done to eliminate two potential major problems: To do even invasive glucose measurement, the user is supposed to wash their hands first with soap and water. How many actually do that? Approximately zero. People are not aware of this but the difference in readings between washing and not washing their hands is tremendous. The same goes for calibrating our device. If it is not properly calibrated, with clean hands, then all the readings will be off and that will not be good.

“Next, the patient using the standard invasive methods will use any standard low-cost calibration device on the market and none of them are accurate enough. The clinics use state-of-the-art medical calibration systems for spot-on calibration. We use the highest-quality device to calibrate and we insist that all of our authorized clinics use the same device. Also, it’s only once or twice a year and all diabetic patients must visit their clinic or physician at minimum the same amount of time. So you’re going in for your checkup anyway, why not calibrate your GlucoTrack at the same time?”

Most diabetics need to test themselves five to seven times a day, some even more than that. In type I diabetics, improper monitoring of insulin will have immediate and life-threatening consequences. However, in type II diabetes, there is a range of complications that are not seen immediately, but build on themselves over time: vision problems, kidney disease, nerve disease, even heart disease and limb amputation. These can only be controlled or perhaps even prevented by monitoring more frequently.

However, because of the pain and complication of the monitoring, type II diabetics are much more likely than type I diabetics to avoid the monitoring that they should be doing as part of a daily routine. “Our device removes all excuses. It is easy to use, extremely accurate, and totally painless. It is even cheaper to use than the invasive methods in the long run,” Gal said. “ Just clip the sensor to an earlobe and it starts to measure. They don’t even have to press a start button. It runs for one minute and provides an accurate glucose level reading. It can store up to 1,000 readings that can be viewed by chart, graph, or numbers. This is very useful for both the patient and the physician.”

So what's the next step for Gal and Integrity Applications? He said that currently they are preparing for mass production and are in negotiation with a company for that. Simultaneously, they are looking at finding the best distribution.

“A year from now I expect to have a good sales flow and to have another device in the family that can be used for minors," he said. "The current GlucoTrack is only for 18 years and above. We recently received the approval to do clinical trials with minors from 6 years old to 18 for CE approval and we expect to be in the middle of starting the approval process with the FDA."

If anyone can do all of this in one year, Avner Gal can. 

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