Avner Gal, CEO of Integrity Applications, LTD is a man of many talents. He and his company have developed a non-invasive glucose monitor for adult diabetics, but to know the man, you have to go back to the beginning. After 23 years in the Israeli Navy, Gal retired as a Commander and embarked on a second career as an electronic/electrical engineer, using all the training he had obtained while in the service. He holds a bachelor's of science in Electrical Engineering from the Technion, in Haifa, Israel, and a master's in Electrical Engineering from the Naval Postgraduate School in Monterey, Calif. He completed an MBA with a focus on marketing from the Israeli branch of the University of Derby, UK, and spent a few years running his own independent consulting company.     

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Then, 12 years ago he joined a high-tech industrial measurement company and although he didn’t know it at the time, his life was about to undergo a complete change. His CTO was Dr. David Freger, who was also a diabetic who was sick and tired of continually having to prick his fingers to draw blood for glucose measurements multiple times a day. This planted the seeds for Gal’s third career.

“He came to me one day and asked me to think about developing a non-invasive glucose monitor. At that time I knew zero about the field, but I told him it sounded challenging and interesting. I like challenges and I definitely like interesting things, so I told him, let’s go for it,” said Gal.

The problem was that both of them were employees and the company itself was not in the medical field. They presented the idea and were turned down flat by the heads of the company.

“I thank them every day for rejecting the idea,” said Gal with a laugh. “But, seriously, David Freger, myself, and David Malka who was the CEO of the company, all resigned and founded Integrity Applications. Our only goal was to develop a non-invasive glucose monitor.”

Unfortunately, near the end of 2004, while Integrity was still in the early stages, David Freger passed away from diabetes complications. Gal and Malka decided to memorialize his name. “So while our product brand name is GlucoTrack, all the models and accessory names are DF-something, for David Freger,” said Gal. Examples are:

DF-B: Basic model for use in developing countries

DF-F: Most current model of GlucoTrack

DF-C: Continuous monitoring of glucose levels

DF-N: Night time advanced warning of hypoglycemic episodes

DF-D: Warns drivers of low glucose level

DF-I: System for pediatric Incubators

DF-P: Device for Pre-diabetic (IGT) users

From startup to today, Gal’s focus is on improving glucose monitoring 24/7. He explained that until recently, the only way to monitor glucose levels was to prick a finger or use a continuous monitor, which is also an invasive. “A continuous monitor uses a needle that goes into the abdomen or into the arm. It is accurate, but it is invasive. You have to replace it, recalibrate it on a daily basis, and it involves a lot of needle pricks,” said Gal. “Our goal was to be able to measure the glucose level with enough accuracy to either eliminate the need to prick yourself completely, or at minimum, greatly reduce the times a person has to prick their finger--by combining between a non-invasive and invasive device to take the measurements.”

First, the company did research to see what other developers were working on in this area. They found that at the time, almost everyone was basically looking at some form of optical technology. After studying this, they came to the conclusion that optical would not work.

“We rejected it and did not spend a penny on any research into it. We don’t use it today in any way,” said Gal. “You have to realize than none of us came from the medical arena, which turned out to be completely in our favor because we were completely unbiased. We were open to look at any technology that made sense and did not jump on a technology simply because the medical arena was looking favorably at it.”

They knew how to accurately measure, and this was a measuring need, but very complex because it is the human body. The solution they came up with was unique and stands apart even today. “When talking to engineers, you want to show them that you understand signal-to-noise ratio challenges. We do because we come from that market. Because of that, design engineers connected with us immediately. We spoke the same language,” said Gal.

Signal-to-noise ratio is a problem that every engineer deals with in many electronic devices. It needs to be as high as possible. The signal in this case was the glucose. It was a given. The noise must be dealt with and reduced as much as possible in order to increase the ratio. The question was how to do that.

“We came up with a very unique approach,” explained Gal. “We combined a few independent technologies so each worked independently and eventually produced a variety of measurements or readings. Then we created an algorithm that would take all of these into consideration, give each a different weight, and calculate this weighted average. That that would be the reading the device will give.”

That was the approach. But, of course they had to test a variety of technologies and choose those that would not negatively affect each other when put together within the same device. All these questions led to the three independent technologies that they use today: ultrasonic, electromagnetic, and thermal.

The first iteration of the glucose monitor was a very big box with three different spaces for each technology. Every iteration improved the size, shape, and effectiveness of the device. “We went through all the clinical trials, collecting the data, analyzing the data to see what could be done to improve the device. Then we would go back to the clinic and retest again,” said Gal.

The challenge of how and where to start was completed, but then the next question was when to stop and decide that the device was good enough to market. They could then continue with new iterations as an ongoing function of the company--as every other company does.

“In 2011, we came to the conclusion that our device was good enough,” said Gal. “We froze the technology, to concentrate on the visual aspects of the device and put it through the official clinical trials to get the CE mark. We decided to roll it out first in the European market. It’s not easier than the FDA, but it is faster.”

The current device consists of an ear clip that contains the three sensors, and each works by itself. There are three independent readings. Then the proprietary algorithm binds the readings together, adds some other parameters and gives a different weight to each of the readings, then delivers the true, weighted average. The measurement takes about a minute. The ear clip connects via wire to a receiving unit that looks like a cell phone.

“We did not want to go wireless because wireless technology brings in other problems,” explained Gal. “You must have a battery in the sensor, which makes it bigger. Also you have to recharge it, and there is a wide variety of potential interference in wireless that you don’t get with wired devices. Of course, eventually when we move into doing continuous monitoring, the sensor ear clip will need to be totally different and it will have to be wireless at that time, but talking about basic measurement such as replacing a needle prick several times a day, there is no benefit having a wireless device.”

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