Ah, non-invasive glucose testing. It's the dreamed-about Holy Grail of Diabetes, something we know could someday exist but seems to remain just beyond reach.
There have been oodles of attempts at non-invasive approaches through the years -- everything from the failed GlucoWatch concept to more recent designs promising glucose readings through tattoos, tears, sweat, saliva, fingerprint and eyeball scans, and even contact lenses.
Now there's another one on the scene, Folks. This one is called GlucoTrack, and it offers us the ability to test our blood sugars without having to poke our fingers or draw any blood. All we need to do is put a clip on our earlobe. Well, this isn't actually new; the product's been in development by Israeli company Integrity Applications for the better part of a decade now, and you may remember our coverage of this very device back in 2009, and other coverage going back to 2006 about GlucoTrack "coming soon."
As with most of these non-invasive prototypes, approval was expected to be right around the corner... but that didn't materialize. Flash forward to Summer 2013, and GlucoTrack finally secured CE Mark approval to sell in Europe, and now hopes to submit the device to U.S. regulators as soon as possible -- with a plan to conduct clinical studies here sometime this year.
The GlucoTrack DF-F model is a high-tech earlobe clip that measures glucose using three kinds of technologies: ultrasound, electromagnetic, and thermal. You just clip the GlucoTrack sensor onto your earlobe and within a minute, it sends your BG data through a headphone-style cord to a smartphone-sized handheld controller. And that's where the glucose reading is displayed or even verbally announced.
Integrity Applications points to clinical data collected since 2009 at the Soroka University Medical Center in Israel, which they say demonstrates accuracy comparable to existing fingerstick meters -- but the data published on their website seems to indicate a 20-30% deviation within GlucoTrack results, far higher than that of existing meters and CGMs (?)
Apparently, you only need to replace the personal ear clip every six months and we're told that Integrity Applications is also mulling over the idea of a continuous glucose monitoring clip (earlobe CGM!)... though that's kind of a head-scratcher, since it's hard to imagine people wanting to wear this bulky-looking clip hanging from their earlobe all the time.
OK, before we go any further, take a look at this GlucoTrack commercial. But be forewarned: Side effects of this ad may be eye-rolling, head-shaking, laughing and disbelief at the overly dramatic and unrealistic depiction of what it's like to take a fingerstick blood sugar test out in public:
Seriously, I know it's a commercial for GlucoTrack and it's meant to spin the whole "fingersticks are evil and inconvenient" mentality. But I just can't watch this video spot without busting out laughing. The guy appears very stressed out about going to check his blood sugar, in a restaurant bathroom no less (did someone say Miss Manners?!). Seems more like a spy waiting to connect with his contact rather than a real-life PWD (person with diabetes) so sweaty and nervous about a simple glucose check.
Yes, I understand that fingersticks may be harder for children with diabetes than for adults. And those diagnosed later in life, or who don't have to do multiple tests a day, might be more anxious than others. But I'd put money on the fact that none of us get as dramatic as the person in this ad. Who's got the energy for that, when you're testing so many times a day?
To me, this commercial sends the message that the people behind GlucoTrack don't "get it" when it comes to life with diabetes, especially the type of D-Life we have in 2014 with tiny meters and smartphone apps that make glucose testing quite convenient and discrete compared to old-school meters that were the size of a brick. The guy in the ad is wearing a suit coat, so if he's so concerned about discretion, why wouldn't he just put his little meter, strips and lancet device into a coat pocket, instead of standing up and making a scene by lugging an entire briefcase into the bathroom and acting all suspicious? And lastly on practicality: it seems highly doubtful that pulling out this clunky ear-clip device in the middle of a restaurant would get fewer sideways glances than doing a fingerstick test.
All that skepticism aside, we were curious about the plans to develop and market this product, so we connected with Avner Gal, an electrical engineer and CEO of Integrity Applications who's one of the scientific brains behind GlucoTrack. The whole idea for this non-invasive device came from Integrity's co-founder, the late Dr. David Freger, who was living with type 2 and was tired of having to poke his fingers multiple times a day. Sadly, he passed away from a stroke in December 2004, so in his honor, the current model is called the GlucoTrack model DF-F, for David F. Freger.
Here's what Avner Gal told us through a recent email Q&A:
DM) First, tell us a little more about Dr. Freger and how GlucoTrack was first envisioned?
AG) Dr. Freger never measured himself since he couldn't stand the needle pricking. This was the trigger for the development of GlucoTrack. The story of Dr. David Freger appears on our website. He suffered from type 2 diabetes for about seven years. GlucoTrack intends to help prevent these situations. Dr. Freger passed away at the age of 48 due to diabetes complications.
People have been hearing the diabetes non-invasive pitch for decades, and our patient community often rolls our eyes anytime another device makes this claim... why is GlucoTrack any different?
Thus far, the vast majority of trials to develop a non-invasive glucose monitor have been based on optical technology. During our feasibility study, we came to two conclusions. First, optical technology cannot be used for glucose monitoring; and second, a single technology is not enough to make a non-invasive measurement. Based on these conclusions, we've developed GlucoTrack using three independent technologies (none optical), which are being combined by a specific algorithm that gives different weight to each technology and calculates the weighted average. In short, GlucoTrack uses a completely different approach, based on multiple sensors and multiple technologies.
Why can't optical technology be used? What specifically did you learn to come to that conclusion?
So far, all the optical technology that has been attempted for non-invasive glucose monitoring has failed. The three main parameters causing problems for optical tech involve physical properties of the epidermis: namely, skin roughness, perspiration and pigmentation. These properties act like a distorting lens, skewing optical measurements. Skin roughness is asymmetrical—it is challenging to calibrate readings as a result, since it's almost impossible to use a sensor precisely. Also, perspiration levels are changing constantly for a variety of reasons (emotions, diet, etc.), so it also can't be calibrated properly. Finally, skin pigmentation can change as a function of ambient light—a phenomenon that is not necessarily distinguished by the naked eye. Consequently, this parameter as well cannot be calibrated precisely.
Why the earlobe?
The earlobe is a very convenient place on the body to measure one's blood sugar levels, since doing so doesn't interfere with one's activities. From a physiological standpoint, there are also specific benefits to using the earlobe. For example, the earlobe contains a great number of capillary vessels, and blood within it flows relatively slowly. It also contains a relatively small amount of fat and nerves, as well as no bones. All of these facts help to ensure a better reading. In addition, the earlobe is relatively stable in size in adults, which similarly helps to maintain validity of calibration for a relatively long period of time.
How accurate is GlucoTrack?
GlucoTrack shows 97% of the readings in the A and B zones of the Clarke Error Grid, of which about 43% are in the A zone. All the data is available in a variety of posters and articles published on our website.
Now that it has CE Mark approval, is GlucoTrack available overseas? If not, when will it become available and where?
GlucoTrack has not yet been sold, since we are now preparing the mass production line. We expect to start selling in this quarter (Q2/2014). Sales will be made through distributors in a variety of countries, including Australia and Italy. Although still in the process of recruiting new distributors, the current list can be found on our website. Please visit our site occasionally in order to see updates.
What's the timeline on getting GlucoTrack to the U.S.?
We expect to begin the clinical trials in the U.S. this year (2014).
How much will the device cost?
The recommended retail price for GlucoTrack model DF-F is $2,000, while the Personal Ear Clip, which must be replaced every six months, has a $100 RRP. GlucoTrack will be cheaper to use than conventional (invasive) devices in the long-term, with the length depending on number of measurements per day.
How does the cost compare to using a CGM?
On one hand, the cost for CGM is much higher than GlucoTrack. On the other hand, GlucoTrack is a spot device. Therefore, a comparison with CGM is not relevant, although it's favorable to GlucoTrack. As per invasive devices, the comparison is very straightforward. Even if we assume that an invasive device is given for free, measuring oneself five times per day costs over $1,500 yearly: $1 (strip and lancet price) x 5 (times per day) x 365 (days per year) = $1,825 every year. On the other hand, GlucoTrack costs $2,000—a one-time purchase (including one Personal Ear Clip) and $100 (for an additional Personal Ear Clip in the first year) = $2,100 total, with no pain. So there is a major difference even after a little more than a year—including the ability to measure oneself a virtually unlimited amount of times daily, and the ability to forget about pain.
Let's talk about that video commercial... from a patient perspective, it seems rather ridiculous. Do you see that depiction as possibly turning people off or deterring them from taking GlucoTrack seriously?
I strongly disagree with your characterization. There exist a minority of people who do not care about the prick, but they are really an extreme minority. I believe the video represents the majority. That said, I am confident that the video won't deter people from taking GlucoTrack seriously. Overall, people do not enjoy pricking themselves. The fact that most diabetes patients do not measure themselves as they are supposed to—washing hands with soap prior to measurement—doesn't mean that that's the right way. For a deeper perspective, I strongly recommend you read this article by J. Hortensius et al. in Diabetes Care, Volume 34, March 2011, pp. 556—560.
Your website FAQ says there's a plan to develop a continuous model of GlucoTrack... how would that work?
The continuous monitor is in the roadmap of the company's future, and is not guaranteed. If and when it will be developed, the ear clip will definitely be in another shape, be wireless and would be worn for as long as the user likes to conduct measurements.
What kind of software does GlucoTrack have, and does that include smartphone connectivity?
GlucoTrack does not have a connection to a smartphone. Data can be downloaded to a personal computer by simply connecting the Main Unit to a computer via a USB cable, to be supplied with the device. The basic data will be presented in a format similar to an Excel spreadsheet.
A big concern for many PWDs is allowing data to be shared between glucose monitors and other devices like insulin pumps and CGMs... are there plans for GlucoTrack to offer that kind of interoperability or smartphone connectivity soon?
GlucoTrack doesn't currently communicate with an insulin pump.
As a public company, we cannot share information that has not been disseminated publicly. Therefore, I cannot say anything more than that the current model of GlucoTrack does not communicate with a smartphone.
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And we say: Kudos to people like those at Integrity Applications who are pushing for innovative solutions to limit fingersticks.
We'll just have to wait and see how it stacks up to proven technology like Dexcom CGM, and that company's own push to someday eliminate the need for fingerstick calibrations -- and other non-invasive CGM concepts, like the one from Echo Therapeutics that could be getting closer to reality.
Meanwhile, there's no reason modern glucose testing needs to make us resort to clandestine spy-like behaviors in the name of being discreet. To anyone who says otherwise: well, I doubt you know what you're talking about.