The portable GlucoTrack device can accurately measure glucose levels on-the-spot.An Israeli company has developed an innovative new non-invasive measurement system for diabetics that will enable them to check their glucose levels painlessly, without having to prick their fingers.

The new device, which is expected to reach the US market during the second half of this year, is called GlucoTrack, and unlike other non-invasive measurement devices, it combines three independent technologies that are operated simultaneously to provide an accurate and reliable on-the-spot reading of glucose levels in the blood. The technologies include ultrasound, conductivity, and heat capacity.

In the US, a massive 20.8 million people have diabetes (7% of the population), of which 6 million are unaware that they have the condition, according to statistics from the American Diabetes Association. These figures are also rising dramatically. The association points out that a further 41 million Americans suffer from pre-diabetes, or Impaired Glucose Tolerance.

GlucoTrack, which was developed by Ashkelon start-up, Integrity Applications, consists of two parts, the main monitoring system which includes a portable display and is about the same size and weight as a cellphone, and a small sensor that contains the sensors and calibration electronics, and clips onto the earlobe like a clip-on earring. This can be adjusted to fit just as easily.

Users input their data into the machine, and can then after a short calibration start using the battery-operated device. The ear clip is attached painlessly to the ear, and users can painlessly measure blood glucose levels as many times a day as they want. The combined result is displayed on a digital screen. If blood glucose levels rise too high or too low, measurements predetermined by the user, an automatic visual and audible alarm goes off.

“We made it as simple as possible to operate because many diabetic patients are elderly,” says founder and CEO, 51-year-old Avner Gal. “They just turn it on and push a button.”

Each monitoring device can support up to three different users, but ear clips must be calibrated for each individual user. Since Type 1 diabetes is hereditary, this is a cost-saving exercise for some families.

Development of the device, which has already been patented, has been completed, and Phase 2 clinical trials in Israel, the US and Spain are set to begin in the next couple of months.

For diabetics, monitoring glucose levels is one of the most crucial parts of controlling their disease. It is also, however, one of the most problematic. Most diabetics grow weary of the constant pain of pricking their finger to check glucose levels. While the number of times this needs to be done varies according to the type of diabetes and the progression of the illness, Gal estimates that it should be done at least four to eight times a day. “The more the better,” he told ISRAEL21c. “The more you do it the more you can control the symptoms of this disease.”

In reality, many diabetics, particularly type 2 diabetics who develop the illness in adult life, tend to check glucose levels far less, sometimes only once or twice a day, or even once or twice every four days.

“This is not a good situation for the patient,” says Gal. “They do not know what their condition is and do not treat themselves to the correct medicine. Diabetes is an illness that can lead to all sorts of serious health complications if it is not controlled correctly, ranging from heart disease, to high blood pressure, kidney and eye damage, and even amputations. For health authorities or medical insurance companies this inevitably means dramatically increased costs.”

On the other hand, if patients monitor themselves frequently, as Gal believes most will if the test is painless, then treatment will also be optimal leading to less damaging side effects, and less doctor and ER visits.

“With careful and accurate monitoring, the patients can decide the optimal timing to take their medicine, or can refer themselves in time to a doctor if the results show an aggravation or deterioration in condition,” says Gal.

The incidence of diabetes is growing rapidly worldwide. Many doctors and healthcare officials now refer to the disease as an epidemic. According to figures from the International Diabetes Federation, worldwide about 190 million people suffer from diabetes (about 7% of the adult population), and that figure is expected to leap by 72% by 2025, when an estimated 324m. will suffer from the disease. “This is one of the most rapidly growing diseases in the world,” says Gal.

Pre-diabetes, or Impaired Glucose Tolerance, is perceived as a major step in the development of the diabetic condition, and is attributed to poor diet and exercise, and genetic predisposition. The US has a disproportionately large community and growth rate of diabetes sufferers due to factors that contribute to the onset of diabetes, including obesity.

In 2002, diabetes cost the US an estimated $132 billion. Direct medical expenditures totaled $92 billion (compared to $44 billion in 1997), while indirect costs resulting from lost workdays, disability and mortality, totaled $40.8 billion. In 2002, diabetes alone represented 11% of the US health care expenditure.

Integrity-Applications was founded in 2001 by four men, Gal, David Malka, the VP of operations; Zvi Cohen, and Dr. David Freger, the company’s former CTO. Freger suffered from type 2 diabetes and in December 2004, died of a stroke connected to his illness, at the age of just 48.

The founders came up with the idea because Freger was sick of having to prick his finger every time he had to check his glucose levels, and dreamed of finding a non-invasive alternative.

“We realized there was an urgent need for such a product, and that it was a very large market, giving us all the reason in the world to work on it,” says Gal.

The expertise of the founders was in measurements, rather than medical devices, so they approached the problem from this perspective. One of the difficulties with creating a non-invasive glucose monitoring device, they realized, was accuracy. “The human body is very complex and the accuracy levels required from blood glucose measurements must be very high,” explains Gal. “A single technology was not enough to create the necessary accuracy.”

The answer was to use three independent technologies to monitor blood glucose levels and then correlate the results. “Developing the three different technologies was relatively easy,” says Gal. “The hard part was combining them into a single device with a single interface and point of communication between them. It took quite a lot of effort to overcome this problem, but eventually we did.”

Initially the team invested their own money in the project, but afterwards raised $2 million in money in four rounds of fund-raising from angel investors. The product was patented in the US last year and will be patented through Europe and the rest of the world in the coming months. Gal admits he is proud of how much Integrity-Applications accomplished with so little money.

Today the company is in the midst of raising a further $1.5m., from private investors. The company plans to use this money to put the device through Phase 2 clinical trials and to start marketing it worldwide. (Phase 1 clinical trials were held at Soroka Medical Centre in Beersheva). If all goes well in these new clinical trials, CE approval should be approved in the second half of this year, while FDA approval should take a further year. Gal expects the device to reach the US market in the second half of 2007.

Gal says the company is now in negotiations with major European distributors. It plans a step by step introduction to the European market. The UK will be one of the first markets, according to Gal.

In Europe, the GlucoTrack device should cost around 2,000 Euros. Initial outlay is more expensive than traditional invasive methods of blood glucose monitoring, but since the unit is not disposable, and the ear-clip must only be replaced every six months, Gal says the price is cheaper in the long run. A leasing alternative is also considered seriously. The company plans to create a series of versions of GlucoTrack for different types of personal use.

Currently there are about 10 companies worldwide developing non-invasive methods to monitor blood glucose levels. Gal insists, however, that Integrity-Applications stands out from its rivals not only for its accuracy, but also because it only needs to be recalibrated once a month. “Other devices must be recalibrated every few hours or days. This is time-consuming and annoying. Our system only needs to be recalibrated every month and the process is very simple,” he says.

In addition, he believes that GlucoTrack will be first to market.

The real advantage of GlucoTrack, Gal believes, is that diabetics will start to monitor their condition more closely and more effectively, leading to improved health care, lower health risks, and lower health costs. “The diabetes market desperately needs a non-invasive glucose level monitor,” says Gal. “A non-invasive device approved by CE and the FDA will be easily sold in very large quantities worldwide.”