Like so many diabetic patients, Dr. David Freger avoided measuring his glucose levels. He hated the prick, and the pain and anxiety it brought. His mind, wired like an inventor’s, decided there must be a less-painful, less-stressful way to measure.
Freger recruited two colleagues to develop a non-invasive device: Avner Gal – a retired commander from the Israeli Navy, with expertise in electrical engineering, applied technology, intelligence systems, and electronic warfare – and David Malka – who’s had manufacturing experience since the early 1990s as a designer and production manager.
Early in the development process, in 2004, Freger passed away from complications with his diabetes, Gal says.
“Afterward, we started checking with ourselves,” Gal recalls. “Are we going to be able to keep going by ourselves and get a final working device?”
Ultimately, the project went forward, and a decade later the GlucoTrack has distribution deals across the world. In tribute to their friend, Gal and Malka gave the device two letters: “DF” for David Freger.
“It’s our way of memorializing him,” Gal says.
It’s been a busy year at Integrity Applications. The press page of the Israeli company’s website is populated with releases touting the accomplishments of its non-invasive glucose-monitoring device, the GlucoTrack DF-F.
Distribution deals for the battery-operated product have been signed in markets worldwide – including Italy, Australia, Taiwan, and Uruguay – and it received CE mark approval for six-month calibration validity in March, a step up from the monthly recalibration mark it obtained in June 2013. Avner Gal, president and CEO of Integrity Applications, also makes it clear the company is eyeing another big market – the United States – and says the device is in the beginning stages of gaining FDA approval.
Two major advantages separate the GlucoTrack DF-F from other glucose-measuring devices: It eliminates the pain of taking a sample and lets users digitally track their results, says Gal.
GlucoTrack includes two primary features – a main unit (MU) and a personal ear clip (PEC). Smartphone-sized, the MU digitally saves users’ data histories in charts and graphs, making it easy for them to track and access their reading patterns. This is especially useful, Gal says, during a vacation, when a user may want to indulge. If he punches in the bookend dates of the vacation, the device will show the average glucose levels of that duration.
In addition, Gal says the MU is user-friendly for visually-impaired or blind people because it can read results verbally.
“When you’re talking about diabetes, blindness or vision problems are very common,” he explains. “But very few technologies have the ability to be used by a blind person.”
Despite the benefits of the MU, Gal calls the PEC the most important part of the GlucoTrack. That’s the part of the device that eliminates the pain from taking glucose readings. Gal says the sensor simply clips on to a person’s earlobe, and “the rest is done automatically. Within a minute, you get the result.”
The PEC is precisely designed not to pinch a person’s ears, and instructions are included explaining how to adjust the clip so it’s not too tight or loose on a person’s lobe.
“If it’s too tight, then it actually will change the characteristics of the tissue,” Gal explains. “This is not good for the measurements.”
Innovations and invention are not synonymous. Sometimes an innovative product just needs to uniquely combine available technologies to create something new.
The GlucoTrack is an example of this type of innovation. It incorporates three technologies – ultrasonic, electromagnetic, and thermal – that together measure what Gal calls “physiological phenomena of the body” to produce a glucose reading.
Gal says the main designing obstacle with the GlucoTrack was figuring out how to increase the signal-to-noise ratio, which allows non-invasive devices to make readings from the body. Gal had two options to raise the ratio. He could increase the signal level or decrease the noise level. However, increasing the signal level is practically impossible, so his team decided to decrease the noise. Through a patented approach, Integrity Applications uses the three technologies to do just that.
“Nobody before has thought about combining the three technologies together,” Gal explains. “You don’t really measure the glucose itself, you’re measuring the physiological phenomena of the body, which is correlated with the glucose levels.”
When the PEC takes a measurement, it processes a signal from each one of the technologies. Then, Gal says, through software in the MU, an algorithm takes those three signals and calculates their weighted average, which registers as the glucose reading.
When Integrity Applications perfected its technology and package, it focused on the two most widely recognized regulatory paths: the European CE mark and the U.S. FDA’s approval.
A third party at Soroka University Medical Center, a leading hospital in Israel, conducted the set of trials for the CE mark. It used a pair of measurements – one from the GlucoTrack and the other from a reference device, which is the gold standard of reading glucose levels. The team looked at the correlation between the two measurements. When it decided the difference was satisfactory, it approved the GlucoTrack for official trials. In June 2013, the device passed, but the PEC had to be recalibrated monthly. In March 2014, the GlucoTrack was approved with six-month calibration validity.
Gal divides the production components of the GlucoTrack into two broad categories: the electronics and the mechanics.
“For the electronics,” Gal emphasizes, “everything, with no exception – including the hardware, software, and algorithms – was developed in-house by our own engineers.”
For mechanical design and production, the company did reach out to subcontractors. Integrity Applications itself will not mass manufacture the GlucoTrack. Subcontractors in Israel will do the first 10,000 or so units, and then for mass production, Gal says the company plans to use another subcontractor to keep costs low.
“When we started to do more devices that might be achievable to the market, we started to work with these external subcontractors,” Gal explains. “The main structure of the main unit, the external as well as the internal parts, as well as the ear clip – all this has been done by external contractors.”
Though recently released to market, Gal says the company already has tentative plans for new devices. One idea is a product geared specifically at developing countries.
“It will be much simpler, without all the features,” he says. “It will give the basic features, such as measuring and some memory, but it will be much cheaper.”
Gal also has ideas about building a continuous monitoring device aimed at patients with Type 1 diabetes. He says he’s enthusiastic about the future for the company and its GlucoTrack device, saying the company’s current focus is on continuing to sign distribution agreements and preparing for mass production.
About the author: Danny English is an associate editor for TMD and can be reached at 330.523.5354 or firstname.lastname@example.org.