Type 2 diabetes currently afflicts more than 371 million people worldwide, according to the International Diabetes Federation, and the number of people diagnosed with Type 2 diabetes is increasing each year. These rising numbers put a burden on physicians tasked with giving their diabetes patients the best treatment and advice.
One promising approach is for physicians to inform their patients about advances in noninvasive self-monitoring of blood glucose. A device that allows noninvasive self-monitoring offers benefits for both doctors and patients. On one hand, it encourages patients to measure their blood sugar more regularly. On the other hand, by recording blood glucose levels over a period of time, it gives physicians the ability to obtain information about a patient’s blood sugar history, and therefore better manage side effects.
Among those who have diabetes, the importance of being diligent about self-monitoring one’s blood glucose cannot be overemphasized—nor can anyone deny that the present status of self-monitoring leaves a lot to be desired. The finger-prick, the blood and the coated strips can be messy, complicated to use and painful—and these issues can contribute toward patient noncompliance. An aim of the medical device community has been to develop a blood glucose monitoring device that is noninvasive but still highly effective, and thereby eliminate what are believed to be two of the most prominent roadblocks to frequent monitoring of blood glucose by diabetes patients: pain and cost.
To address this need, Integrity Applications, headquartered in Ashkelon, Israel, has developed the GlucoTrack model DF-F non-invasive blood glucose measurement device, which it believes represents a significant advance in this area. This device is designed to help those with diabetes obtain blood glucose level measurements without the pain, inconvenience, incremental cost and difficulty of conventional (invasive) spot finger stick devices.
The GlucoTrack device takes advantage of the natural physiology of the ear lobe and employs an ear lobe clip to deliver blood glucose readings in about a minute, thanks to three technologies: ultrasonic, electromagnetic and thermal. Last June, Integrity Applications received CE Mark approval for the GlucoTrack DF-F model device. As a result, Integrity is permitted to sell the device in the 28 member states of the European Economic Area. Additionally, Integrity has signed agreements with distributors in Australia, New Zealand, Turkey, Lithuania, Latvia, Estonia and Belarus, with more agreements expected in the near term, although no sales have been made yet under these agreements.
The GlucoTrack DF-F device consists of two major components: Main Unit and Personal Ear Clip (PEC). Supporting up to three different users, the Main Unit is comparable to a smartphone in size, weight and functionality. It features an easy-to-use color touchscreen, employs a built-in lithium-ion rechargeable battery and includes a USB port for data downloading. The device both displays and speaks out the results of the blood glucose reading, and has memory capacity large enough for 1,000 readings per each user. The PEC is comfortable and adjustable, individually calibrated, and has an operational lifespan of up to six months (although more frequent replacement or recalibration might initially be required by some regulatory authorities), which reduces costs.
Why choose the ear lobe as the monitoring site? From a usability perspective, the ear lobe is nonintrusive, so utilizing it for blood glucose monitoring is convenient for the user. More importantly, the ear lobe contains a large number of capillary vessels, and the flow of blood within it is relatively slow, thus offering favorable conditions for obtaining more accurate measurements. Additionally, the comparatively minor amount of fat and nerves in the ear lobe, as well as the absence of bones, reduces the “noise” and thus helps to secure a more accurate reading. In addition, the ear lobe remains stable in size over the lifespan of the PEC, which increases the length of time for which a calibration will remain valid, because users do not have to adjust the PEC due to a change in ear lobe size.
It is important to note that as a noninvasive device, GlucoTrack does not gauge blood glucose levels directly; instead, it harnesses three independent technologies to measure physiological phenomena that correlate with the user’s glucose level. These measurements—which are transmitted from the PEC to the Main Unit—are then analyzed using an algorithm that translates them into blood glucose level readings. Significantly, GlucoTrack does not employ optical technology, which, based on others’ experience, has been determined to be impractical for use in noninvasive glucose monitoring.
Once it is calibrated, the GlucoTrack model DF-F is able to measure blood glucose levels at any desired time of day or night, making it an appropriate solution for a wide range of diabetes patients. Although CE Mark approved, it is not yet available for purchase, since Integrity is still in the preparation phase for mass-production. The device is expected to be available within the European Economic Area during the first half of 2014. Integrity also intends to apply for clearance from the U.S. Food and Drug Administration to market the GlucoTrack model DF-F in the United States. If and when Integrity Applications obtains FDA clearance for GlucoTrack, Americans with diabetes might also benefit from access to this noninvasive technology.
Avner Gal is President & CEO of Integrity Applications, a medical device company focused on the design, development and commercialization of non-invasive glucose monitoring devices for use by people with diabetes. He can be reached at email@example.com.