GlucoTrack: the Holy Grail of Self-Monitoring Blood Glucose Devices?
We know that diabetes is a major cause of kidney failure, lower-limb amputations, blindness, heart disease and stroke, and that it is the seventh leading cause of death in the U.S.
To that end, the importance of being diligent about self-monitoring blood glucose cannot be overemphasized, nor can anyone deny that the current state of self-monitoring leaves something to be desired. The finger-prick, the blood and the coated strips can be messy, complicated and painful – and these issues contribute to patient non-compliance. Non-compliance increases the risk of all those health complications.
A Non-Invasive Option
The holy grail of self-monitoring might be defined as anything non-invasive but still highly effective. Perhaps the most notable example of this is the Intergrity Applications and the GlucoTrack device.
The GlucoTrack DF-F takes advantage of the natural physiology of the ear lobe and uses an ear lobe clip to deliver accurate blood glucose readings in about a minute, thanks to ultrasonic, electromagnetic and thermal technologies.
In June, Integrity received CE Mark approval for its GlucoTrack DF-F. CE Marking is a European designation that means "the product has been assessed before being placed on the market and thus satisfies the applicable legislative requirements enabling it to be sold" in the 28 Member States of the European Economic Area.
Main Components of the GlucoTrack
There are two components to the GlucoTrack DF-F: One is the Main Unit, and the other is the Personal Ear Clip (PEC). Features of the Main Unit include:
- Supports up to 3 users
- Similar to a smart phone in size and functionality
- Easy to use touch screen
- Uses a built-in Li-ion rechargeable battery
- USB port for data downloading
- Displays and speaks results
- Memory capacity large enough for 1,000 readings per user
Features of the PEC include:
- Individual calibration
- Comfortable usage on the ear lobe
- Six-month operational life span
Brief Interview with GlucoTrack CEO
Avner Gal, the company co-founder, President and CEO was kind enough to grant me some time to throw a few questions his way regarding the GlucoTrack device, the U.S. regulatory process for medical devices, and other issues.
Ross Bonander: First things first: Why the ear lobe?
Avner Gal: There are two primary reasons we use the ear lobe. The first is practical.
From a usability point of view, it is unobtrusive. For example, you can monitor your blood glucose using GlucoTrack and still, for instance, continue to work on your computer. It doesn't limit you in any way. The ear lobe is not a part of the body that has a whole lot of practical function, and so utilizing it for blood glucose monitoring is convenient.
The second and more important reason is clinical.
The ear lobe is home to a high density of capillaries. These capillaries are very narrow, and so the blood flow through these vessels is very, very slow. Furthermore, the ear lobe features no muscles, no bone and very, very few nerves.
Because we need the calibrations to stay valid over a long period of time, we need the place where we are doing the measurements to be stable in its characteristics, and for this the ear lobe is perfect.
The device uses three technologies to non-invasively measure blood glucose levels. Can you explain how this works (without giving up proprietary information)?
We are not measuring blood glucose levels whatsoever, because in order to do that, you must either draw blood or use interstitial fluid, and in both of those cases, it is invasive, and our device is truly non-invasive.
Instead, we use three independent technologies to measure some physiological phenomena of the body which correlate with the glucose. Those signals are sent from the PEC to the Main Unit.
We then take these signals and combine them with an algorithm that takes each signal's relationship with the other two into consideration, and together we are able to translate them into glucose readings.
Let's talk about the ear clip.
The ear clip must be replaced every six months. Once six months has elapsed, and for not a single minute more, the device blocks you from using that ear clip.
Why is that? I noticed on one of your recent poster presentations some data regarding the efficacy of the ear lobe clip, and after six months, the data holds up, so why the need for a new ear clip every six months when it seems clear that the quality of the clip doesn't degrade over time?
You have to remember that the clip is a mechanical device, and mechanical devices have a limited lifespan; that's inherently true for all such devices.
We tested the ear clip for longer than six months to ensure that it works properly. But by establishing a cut-off point for the ear clip at six months, we ensure that whether the user is someone who is using it several times a day or only a few times a day, that regardless of how often it is used, it will continue to give reliable and consistent readings for a set period of time.
Where are you in terms of obtaining regulatory approval by the FDA for marketing GlucoTrack in the U.S.?
We have been in touch with the FDA for a couple of years now, and I have spoken with them on a number of occasions. Ultimately they have communicated to us that it would be better to receive CE Marking before approaching them so that they could use the results from the European trials as a reference. They will still require data from a trial conducted in the U.S., and in fact still need to approve the trial protocol, and then after that we can conduct the trial, submit the data and complete the entire regulatory process.
Based on all that, it's just a prediction, but it could be two years before market approval in the U.S. It could be shorter, but when you factor in everything, including the bureaucracy, it's a process that takes time.