Stumble It!
Glucose Measurement In Your Ear. For Real.
A gentleman cornered me at the Diabetes Technology Society meeting earlier this month, and said he wanted to talk non-invasive glucose monitoring. How could I resist?
He said his name was Avner Gal, from Israel. He pulled out a chunky little MP3-looking device, and plugged in a cord with a small clamp on the end. Then he hooked the clamp to his earlobe, and pressed a button. We both watched the progress bar move slowly across the screen, and then beeeeep – 104, in very large digits!
Avner does not have diabetes. But he is CEO of a company called Integrity Applications, that’s apparently on the fast track to market “the first truly non-invasive glucose monitoring devices for home use,” called the GlucoTrack.
According to the website, GlucoTrack “uses ultrasonic, conductivity and heat capacity technologies to non-invasively measure glucose levels in the blood… The device includes a USB port for downloading data for off-line analysis.” It is aimed at both Type 1 and Type 2 diabetics, although it’s going to have to “jump through hoops” to earn adoption by us insulin-takers. (I’ll get to that in a moment.)
The device was approved for commercialization in Europe mid-2010, and the company expects FDA approval in the US about a year later, Avner tells me. I had a load of questions, many of which are addressed on the company’s FAQ page, here.
They’re also working on a non-invasive continuous glucose monitoring (CGM) model with a wireless ear bud like those used for mobile phones. Now we are talking…
But even on the existing non-continuous model, the key question of course is how accurate is it? That’s the deal-breaker, because who’s going to switch to something less accurate than what we already have? The bottom line is that right now, Integrity’s data show that GlucoTrack is more accurate than other non-invasive technologies, but not as consistently accurate as current fingerstick meters.
“We’re working to improve that. Our technology uses three different measurements simultaneously, and then correlates and averages the results for more precise readings,” Avner tells me.
“Fine,” I reply, “But the big advantage of a device like this is doing away with the need for test strips. That only works if you’re accurate enough so people (who take insulin!) don’t need to do fingersticks alongside the ear measurements.”
Naturally they’re feverishly gathering data. Even with improved numbers, they cannot predict whether the FDA would move GlucoTrack out of the “adjunctive therapy” category (a device to be used for extra information only). Grrr.
Nevertheless, for many Type 2s who do not take insulin, and test less 
frequently, the GlucoTrack could be huge:
- no more need to buy expensive test strips
- zero disposables; the ear clamp plastic needs to be replaced only about once every six months
- super-easy operation and big, clear screen
- calibration required only once a month
- battery charge required only every few days, and the battery lasts for several months at least
- the controller unit stores and graphs data, which can be downloaded (currently in Excel format)
Pricing and insurance reimbursement TBD. Avner gets how important this is, so I’m sure they’re aiming for affordable.
Got questions or feedback? You can contact the company here.
Thank you for the interesting report. I could accept a degree of inaccuracy vs fingersticking if it is consistently inaccurate in one direction or amount.
I am reluctant to finger-stick any time other than right before I eat because of the cost and discomfort. If a non-invasive method can be reasonably accurate and affordable, I would use it the way people use CGM to assess post-meal patterns. I could take a reading every 15 minutes to confirm that my dosing for common meals is on track. I would also test my basal more often and it would be pain-free.
Israel is putting itself on the map diabetes-wise. The Solo tubeless pump was developed there and now this GlucoTrack, too.
Posted by: David | November 19th, 2009 at 11:22 amI’m not the sort to get excited about new technologies for testing or treating diabetes until they have been used for a while and all the kinks are worked out. But I WANT ONE OF THESE!! I am going to keep my eyes open and hope to see it when it hits the market. I certainly hope that it will cost less than a regular meter and test strips.
Posted by: Christina | November 19th, 2009 at 11:38 amYou would think to demonstrate one of these devices and to generate some legitimate buzz, he would at least have the sense to give you [as a diabetic blogger] a sample to wear around for a day and see how well it syncs with your regular measurements. To show a normal person with a level around 100 proves nothing!!!!!!!!!
Posted by: mcityrk | November 19th, 2009 at 1:25 pmThanks for providing us with all this information! I really look forward everyday to read your latest post it gives me hope for a much better future.
Posted by: katerina | November 19th, 2009 at 1:47 pmI just got approved for a CGM and I am thrilled to finally have that approval, but oh! do I want one of these non-invasive deals. The best news all day is that it looks like we may be able to look forward to this technology one day soon. Thanks for sharing more cool information!
Posted by: saramy | November 19th, 2009 at 3:20 pmAs with so many other techniques, this is unproven technology being hyped by the inventors/founders in order to fund the company. The 100 or so techniques that preceded this one made similar claims, but never developed a product that worked. Your readers deserve better treatment than your “gee-whiz” recitation of outrageous claims. At the very least, before you use hyped terms like “for real,” make sure it is.
Posted by: John Smith | November 19th, 2009 at 5:50 pmThanks for your expert input, John. I am very well aware of what a difficult challenge non-invasive monitoring is, and have referred to your paper often:
http://www.diabetesmine.com/2009/08/the-search-for-noninvasive-glucose-technology-that-works-where-it-stands-now.html
“For real” in this case simply meant that it’s not just a concept or a prototype, but a working product. How it fares in the long-term on the market remains to be seen.
Posted by: AmyT | November 19th, 2009 at 6:17 pmCombining three indirect and minimally specific methods for glucose determination has little theoretical, let alone practical, advantage over any one of the 100’s of indirect single technologies that have been tested and found lacking over the last three decades. To take advantage of signal averaging [like the founders discussion implies] you would probably need at least 10 and more like 100 channels of noncorrelated data and minimal sample matrix changes not due to glucose over time to have even a remote chance to tweeze out the continuous data he claims to provide. Then of course you have the whole other can of worms to deal with in trusting the accuracy of a single calibration for a month’s time of continuous data. Good luck with such a low probability of success undertaking.
Posted by: mcityrk | November 19th, 2009 at 7:38 pmThis technique will be really beneficial and supportive to test the glucose.. well.. this device is again supervened with the all items which will carry its measurement accurate and the man don’t have to put much efforts to look after for this..
Posted by: health news | November 20th, 2009 at 12:08 amWow~ this is a great news! Finally there is a company come up with a device which is not just a concept or a prototype, but a working product.
I’ve been looking and tracking for this years! I’m type 2 and I hate to prick myself, not even once in a few days! But I would love to measure myself more with no needle prickings.
And for others who don’t really trust in this, please at least go to the company website and read their posters first, I went to their website and downloaded every posters they presented, I think the posters explains everything that THIS IS A REAL DEVICE! I’m looking forward this whatever it costs!
Posted by: EBerry | November 20th, 2009 at 3:24 am@EBerry
Why would you think we did not look at the website and the posters? The only Clark grid I see shows a great deal of spread in the data made up from about 20 points each from 77 patients with no info on the number of days the tests were run over or how frequently calibrations were run and if separate cals were needed for each new patient. With critical points missing on how the tests were run, skepticism is in order under better disclosure is forthcoming—
Posted by: mcityrk | November 20th, 2009 at 4:38 am@mcityrk
Yup, there are important points that you raise, but the answers appear in the poster from EASD (09/09), so either you did not read, or you did not understand.
Posted by: EBerry | November 20th, 2009 at 7:25 amAnyway~ this is good that such a working product seems more real than others, you can keep skeptical but you can not kill people’s hope!
If this is accurate enough to detect hypos and give general patterns, then it is the answer to my prayers! If it can reach this kind of quality, then I am sure you will sell it by the zillion – and please let me be one of the first in the queue (for my small daughter who has type 1)! Very happy to volunteer as a guinea pig if you need one!
Posted by: Debbie Young | November 20th, 2009 at 9:26 am@EBerry
Thanks for pointing me in the right direction,I did miss the Vienna poster and it answers a lot of my questions. Frankly, it was much better than I expected although the calibration protocol in not trivial and might require some professional assistance. However, if it really holds up over the long term and does not need to be repeated then they have something if accuracy can be further improved.
For the record here is what they said about calibration protocol and duration of calibration intervals:
Calibration: Calibration is performed individually against invasive basal and postprandial capillary fingertip BG references. Six invasive pre and post-prandial measurements generate individual calibration. The first measurement pair is taken in the fasting state. The calibration procedure is easy, lasts about 1.5 hours and more importantly, is valid for a month (a longer period is forecast in the future).
Subjects performed individual calibration against HemoCue® (Glucose 201+), followed by 6 measurement pairs (~2 hours measurement session). 8-10 hours (“full day”) session with GlucoTrack and HemoCue® simultaneous measurement pairs (~30 minutes intervals between pairs). Session included breakfast, lunch and snack. The interval between Calibration and Measurement days was 11.5±10.5days (according to subjects’ availability), with a median of 6 days.
Posted by: mcityrk | November 20th, 2009 at 1:47 pmLets not lose sight of the fact that we all need hope of a future not full of needle sticks. Remember that the makers of the ones we use now was at one time someones dream, the dream of being able to test at home. How great it would have been not that many years ago when home testing was the future yet to come. I think its important to keep dreaming and hoping for a future with far less needle sticks for those of us that test 4 to 6 times a day and feel that we are pin cushions. After all if we lose hope we lose what are the dreams that become our future for making life with diabetes eaiser! I think the news is great, I refuse to lose hope of a brighter and easier future of no finger sticks!
Posted by: Patty A | November 20th, 2009 at 4:46 pmI have heard of this device via an article in an Israeli newspaper some time ago, and find it extremely intriguing and hope they get the glitches ironed out and can market it. Here in Israel, one in 5 adults now have type 2 diabetes, and with the aging of the population, the numbers will only go higher. Supplies for glucometers, and the machines themselves are heavily subsidized by the HMOs called Kupot Cholim, but the inconvenience of drawing blood still remains a big obstacle to getting good compliance, especially with the very elderly. However, when first reported, the price for the device was huge: something in the range of $500, which would not be affordable for individuals but rather for clinics to invest in. I’ve got my fingers crossed–I think it would be a great advance, if it can be affordable, and sufficiently accurate.
Posted by: Antigonos | November 21st, 2009 at 6:20 amAn important correction: it’s written that “The device was approved for commercialization in Europe mid-2010″. I believe it’s typo and want to clarify that we are now in official clinical trials and did not receive any approval yet. We are in the process for that and expecting to achieve CE Mark approval in mid 2010.
Posted by: Avner Gal | November 21st, 2009 at 1:30 pm>>> Dear John Smith, <<<
Posted by: Avner Gal | November 21st, 2009 at 5:30 pmAfter a long hesitation, I have decided to respond to your far from accurate comment.
As opposed to your claim “…being hyped by the inventors/founders in order to fund the company”, during our 7 years of operation, we NEVER did any PR activity and actually worked “below the radar”. This is probably the reason why you didn’t hear about us when you wrote your book, “The Pursuit of Noninvasive Glucose: ‘Hunting the Deceitful Turkey’”. Obviously, this article of Amy has nothing to do with funding the company! Sorry to ruin your theory.
As for the “Unproven Technology”, with all due respect, your claim is based on no real evidence and many dialectologists’ thoughts are on the contrary to yours. Proving the technology is done thoroughly, and by clinical trials. I don’t remember that you ever engaged in discussion with me in order to learn about our unique approach (combining three independent technologies) or about each of the technologies.
I believe that you mislead the readers by referring to “…100 or so techniques that preceded this one…”. There are few technologies for this matter, which the optical is the “leading” one, with variety of derivative techniques. When we began our research, we negated the optical technology. Therefore none of our technologies are optical or optical based.
As for your statement: “…but never developed a product that worked”. Well, here I would agree. However, that said, GlucoTrack® has a proven track record and does indeed work!
You blamed Amy that “Your readers deserve better treatment…”. I believe that your readers should expect from an expert like you a deeper understanding before making any statement against (or in favor of) any device. Moreover (based on your quote), at the very least, before you use hyped terms like “unproven”, ensure that it isn’t.
In summary, we have no intention of giving up just because of few non-scientific statements, and we shall keep working hard to bring a non invasive glucose monitoring device to the market, soon.
By the way, you are in good company: Lord Kelvin didn’t believe that machines heavier than air will ever fly (1895); Ken Olsen (co-founder and former president of Digital) didn’t believe there is a reason for a private individual to have a computer in his/her house (1977) and there are many more examples like that. Well, they all were of course proven wrong…
This is a good news for all diabetics suffering to those fingersticks. Accuracy must be checked properly before the company will release the product. Good luck for the development process of this kind of products.
-sam
Posted by: sam jacob | November 22nd, 2009 at 9:07 amBecause my eight year old son has Type I diabetes and I have Type II, I understand the diffence in the two diseases and the difference in treatments. The one thing that we both have in common is the need to continiously check our blood sugar, more so with my son. When I look at his little finger tips and see all the roughness of the skin because of the frequent pricks he under goes, I am hopefull that there is a better way to perform this necessary test. I applaud Integrity Applications for the work they are doing with developing the GlucoTrack. It sounds like they are working hard to perfect it and hopefully this monitor will be available to people like myself and my son in the very near future.
As for John Smith and his post, it was negative and it appears he is misinformed and overlooked Integrity Applications and their GlucoTrack blood measurement device.
Posted by: Russ Stokes | November 24th, 2009 at 7:45 am