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The Non-Invasive Glucose Monitor No One Wanted (?)
Larry Ishler is an electrical engineer living in Erie, PA, whose son was diagnosed with Type 1 diabetes in college about ten years ago. A few years later, the father had an idea for a non-invasive glucose monitor that would take readings through the skin on your ear (similar to the GlucoTrack from Integrity Applications out of Israel). For years now, he has researched, calculated, tested, and attempted to gain support for his highly accurate system — from the JDRF, the FDA, and the big pharma companies leading glucose measurement. Everyone’s been impressed with his work, but no one seems to want to get involved. Is it some kind of conspiracy, or is this man just ahead of his time? With this post, I present you his story.
{Editor’s note: I’m getting tired of the traditional Q&A, so bear with me with this new format – my ‘asides’ appear in brackets}
Technology Behind the NBG (Non-Invasive Blood Glucose) Monitor
According to his patent, NBG is “a differential measurement system that will include the use of two platinum wires or two thermistors calibrated to record temperatures with an accuracy of at least /-0.035° 
Kelvin (K)… Two regions of the patient’s ear will be used to measure temperature differentials to determine if the patient’s blood glucose levels are rising or falling… (the) system substantially reduces measurement errors by measuring the temperature of the anthelix and tragus of the diabetic patient’s ear.” The stated intent is to produce a non-invasive monitor “that is at least as accurate as the conventional finger stick method.” {Ambitious!}
“I did the research and calculated that because glucose conversion is a process that generates energy, you can track it by monitoring temperature response. The hypothalamus, the part of the brain that controls temperature of the brain and vascular constriction, opens up when glucose is released. The result is that as your glucose goes higher, the difference between your core body temperature and that of your extremities decreases, because more heat is going out to the hands and ears, for example. We found that the signal-to-noise ratio in the ears was better than in the hands, providing a more accurate measure of blood glucose levels.”
Ishler says the competing GlucoTrack product would violate his patent in the US because it also measures ear temperature in a similar fashion, although his NBG is significantly more accurate. “They say they’re measuring three different factors, but in fact they’re all measuring just one physical phenomenon: heat.”
The Product
The NBG’s form factor will be a wireless ear bud, similar to those used with cell phones. Two tiny sensors inside will take readings every single minute, which will be transmitted to a pocket-sized controller with a 2.7-inch touch screen. This will include trend arrows and alarms, etc., and will be USB-enabled for easy data downloading, Ishler says. Downloaded data will be viewable in Excel format.
btw, Ishler wanted the controller built into a PDA, but the FDA shot that down, he says. “They say that technology’s not reliable enough for medical purposes.” {grrrr}
As a true replacement for fingerstick testing, “the savings for Type 1 diabetics in the US is over a billion dollars annually.” {head-rush}
Demonstrating Accuracy
“A couple of years ago we demonstrated the device to all the major strip manufacturers, using infrared cameras that cost $100,000 each (we rented them). One company even invited me to California. They were very polite. I sat in their headquarters and showed them my demo. Then one of their people came here to Erie and tested the NBG for six hours and it was right 85% of the time — meaning it only disagreed with their product’s results two times in six hours. But they said it wasn’t good enough…? The biggest problem is trying to compare, because meters today have a +/- 29% variance,” he says.
According to Ishler, his NBG system is consistently more accurate than any meter to date, demonstrating +/- 10% accuracy across the board.
So What’s the Hold-Up?
Ishler filed for his first patent in 2003. Today, he’s still knocking on doors for support and money.
“There’s just a lot of reluctance to invest in new non-invasive technology because of unsuccessful attempts in past,” he says. To break it down:
“We’ve gone to the universities, but they don’t want to negotiate royalties until after the development is done. The professors get a percentage.”
“The JDRF has told us they’re not funding any new devices for monitoring glucose…”
Regarding investors: “Nobody wants to get involved because they think the FDA will hold it up for years, because the FDA is in the pocket of somebody.”
On the big pharma companies: “I was dumb. I thought they were interested in helping diabetics… but they have their own technology they’re trying to sell. They don’t want to help.”
So What Now?
Despite all the setbacks, Ishler’s still working towards FDA approval. He’s gone through their “novel device disclosure” procedure, and needs to obtain 510K clearance as a next step, which is no small feat when you’re going it alone. He’ll need to conduct clinical studies with Type 1 and Type 2 patients in different age groups and disease states. He’s now trying to get funding for a study including 75 people. Lucky for Ishler, he has found a donor willing to pay at least for the production of the prototypes, which will cost about $750 a piece.
“I tried to simplify the process by applying for approval for use only by Type 2 diabetics who don’t take insulin. But the FDA rejected that idea because it’s a Class 2B medical device (the kind where errors could cause damage to a person’s health), and there’s no way to control which diabetics would use it.”
Ishler has written a detailed white paper and a load of other documentation on the NBG. He’s convinced that the science is sound, and it could be a breakthrough product. He just can’t understand why support is so hard to come by.
“I’m not stupid — I’m not the only one who should have figured this out. But I can’t get anyone to talk to. Nobody wants to discourse on this. I’m really disappointed in JDRF — I mean, why won’t they discourse on the reliability of existing devices and how to improve it? And why isn’t there funding to improve the accuracy of meters that help patients set their dosing levels? Why are we stuck with the current 25-29% inaccuracy?”
{And why are we still getting STUCK, if Ishler’s really onto something here??}
I’ve spoken with Larry a few times over the years, and I think this is a fair representation of the facts. However, Larry needs to decide if he can’t raise the funds on his own whether he is better off selling the technology to a company who can that isn’t going to bury the technology rather than commercializing it!
Posted by: Scott Strumello | December 8th, 2009 at 6:54 amAmy, thanks for this amazing story about Larry’s hard work to get this device to market. How much would that take to complete the studies to get 510k approval? I know it’s a LONG shot, but could a consortium of people with type 1 fund him enough to get past this important step?
Posted by: Bernard Farrell | December 8th, 2009 at 7:20 amBernard, Larry estimates the cost would be roughly $100,000 to $200,000 to gather further research data for this product, which has already gained approval as a prototype that basically can only be used to gather research data. I do think the idea of patient-funded consortium is an idea worthy of consideration, perhaps the idea of paying $500 or $1,000 per participant which would not only provide access to the device, but also be used to gather trial data for submission to the FDA. But an organizer is needed for such an effort … any volunteers?
Posted by: Scott Strumello | December 8th, 2009 at 8:01 amI can imagine that bigger companies may not be interested bc there isn’t an obvious business model. You sell the device – and then where else do you get your revenue stream? Current meter companies depend on the revenue stream from strips, of course.
Posted by: Kristin | December 8th, 2009 at 8:14 amThe story from the Diabetesmine web site on the noninvasive device no one wants sounds like the world has another Purdy (Biocontrol/Diasense) on it’s hands. The device is almost identical to the Integ device which never worked after almost $50 million poured into it. They did have a successful IPO so the VC’s and early investors made money.
Also this inventor thinks that noninvasive glucose device is a 510k. The easiest the FDA will allow is a 510k with a Review Pannel. Time estimate is 1 – 2 years and over 1,000,000 dollars not the very naieve $200k – 300K the inventor estimates. This clearly demonstrates that the inventor has no medical device development experience. Hence there is limited creditability for this invention and it can only be assuaged by a lot of testing to highly controlled and peer reviewed protocols.
The goal is to make life better for diabetics not to endanger them for the sake of convenience.
Posted by: Stephen F. Malin | December 8th, 2009 at 8:32 amOne would think the insurance companies would be all over this product. Insurance pays once and it’s done. No more putting out $75-$100 every month. Now, I don’t know how insurance companies run their business, but isn’t that line of thinking, ummm, I dunno, COMMON SENSE?
Posted by: xim1970 | December 8th, 2009 at 8:50 amit’s all about the strips. the companies must protect their cash cow.
Posted by: anonlurkermom | December 8th, 2009 at 12:45 pmStephen-
Sounds like you have a lot of knowledge on this subject.
I’m glad you are choosing to flaunt how smart you are on this board. Also, thank you for leaving your full name, including your middle initial, this way all of my friends and family can sit around the dinner table and talk about how much of a genius Stephen F. Malin is, how he knows the difference between different levels of FDA regulations, and how we should should all strive to be like him.
I’m so happy you’re using your knowledge in such a proactive way…. I mean, after all, you could be reaching out and HELPING the inventor…but why do that when you can sit behind your computer and insult his lack of knowledge about FDA estimates.
If you’re bored, you could also head down to your local elementary school and insult all the 4th graders who don’t know Calculus yet…those idiots. That would be fun, too, right?
Posted by: Type1er | December 8th, 2009 at 2:03 pmActually, Steven F. Malin has not learned to use spellcheck; he misspelled “Review Pannel” and “naieve” … obviously, this is an individual who has had some experience NOT getting FDA approval for a meter using a competing technology, in spite of several diabetes journal submissions.
Posted by: Type1Reviewer | December 8th, 2009 at 2:21 pmI’m confused…
Posted by: Jason R. | December 8th, 2009 at 4:06 pmIn one hand he claims for fantastic results (better than everything), but on the other hand he says he’s looking for funds to produce devices to conduct clinical trials…
So without clinical trials (few testing say nothing!) how can he claims such an accuracy?
He says that the device will measure every minute, but the graph shows reading every (minimal interval) 1,500 minutes (25 hours!)…
And anyway, what do the different colored points on the graph represent?
Did I mentioned I’m confused???
To Scott Strumello and Larry –
Posted by: Melissa B | December 8th, 2009 at 5:00 pmRegarding Scott’s statement : “perhaps the idea of paying $500 or $1,000 per participant which would not only provide access to the device, but also be used to gather trial data for submission to the FDA. But an organizer is needed for such an effort … any volunteers?”
Yes – I volunteer! I know this would be a monumental undertaking to say the least…but I think I have the resources to do so. Please contact me.
I agree with Type1er!
I too would be interested in paying the $500 to $1,000 to be in the study.
If Melissa B and Larry Ishler can post a contact number that would be great.
I’d even drive to Erie to get the device.
Please keep us posted and Thank You Amy for bringing Larry Ishler’s information to the web! I can’t wait to try it!
Posted by: Cathy | December 8th, 2009 at 5:26 pmMe too, I would love to participate and I am willing to give the money. So now what?!
Posted by: katerina | December 9th, 2009 at 4:51 amI have some idea on how Larry can get possbily all the money neeeded to bring this device to the public.
Can you please forward my email to him. or forward me his???
I would also pay the $1000 to type trial it.
EMAIL ME!!!
Posted by: Whogeorge | December 9th, 2009 at 8:41 amEvery option should be tried. All the Diabetes Associations are NOT there to help us. not at all. They are absolutely worthless.
Hi Larry, my company can help move this forward through the clinical trial process with much of what you need at the lowest total cost for your next step: (http://www.healthcordia.com/gluconix.html)
The path isn’t impossible but the incumbents didn’t make it easy (on purpose I’m afraid). The safety issue must be managed as part of a plan that moves you toward commercialization but that doesn’t necessarily mean that you can’t get this in the field to demonstrate that it works (or maybe not). You can go to our website to send me a message: http://www.healthcordia.com/contact.html
We’ve also figured out how to win $1.5M in competitive grants to date helping to support randomized, controlled clinical trials of our ADMS as we move toward commercialization so that might come in handy, too.
Posted by: Kevin McMahon | December 9th, 2009 at 9:26 amHow cynical it is that big pharma is dis-incentivized to develop a technology that will result in less profit? I guess the problem is mostly money–to have enough to prove the concept and out-last all the FDA hoops.
Posted by: David | December 9th, 2009 at 11:36 amI like that he has a patent. If someone else, such as GlucoTrack or big pharma, gets the concept off the ground they will have to go through Larry Ishler first which is only fair.
I’ve always had suspicion against pharmaceutical companies, and how hard it is now to get advancements in better care, especially for diabetes (type 1, holler!). The only reason I’ve figured is that they now have a great bundle of pocket money coming from us, so why should they fund new ideas that might take away their riches?(I certainly know WE’VE paid them enough for a least a few houses by now….) I dearly hope I’m wrong, if not than I’m absolutely disgusted that MY LIFE is being manipulated so someone else can get fat while we struggle trying to keep me alive.
~Wyndi Sherwood
Posted by: Wyndi Sherwood | December 9th, 2009 at 4:12 pmSign me up to try it too. I’ll even double the offer, pay for one for me and one for someone else!
Posted by: TomP | December 10th, 2009 at 7:26 amThanks Amy for posting the NBG article and thanks to everyone who commented. Continuous testing provides trends finger stick methods do not provide. A diabetic’s blood glucose can go from 150 to 350 mg/dl 90 minutes after eating. I wrote the equations that show the heat produced by glucose conversion in the brain. Then I got a camera and measured the temperature change to demonstrate that my equations were correct. 70% to 90% of the glucose in the brain?s blood is converted producing heat. The main function of the brain?s hypothalamus is. homeostasis, or maintaining the body’s status quo. Factors such as blood pressure, body temperature, fluid and electrolyte balance, and body weight are held to a precise value called the set-point. Although this set-point can migrate over time, from day to day it is remarkably fixed. The brain temperature is regulated within 1C to 1.5C. However heat generated by conversion of glucose causes a .024C ear temperature change per 1mg/dl. I choose a thermistor that had the necessary accuracy and started making measurements. Thermistors are already used in Class IIB medical devices (same classification as a blood glucose monitor) and I started discussions to get FDA approval to use an approved device in a new application. I had the idea that two devices could be made. One for type II diabetics who did not take insulin would use Bluetooth to send the readings to their cell phone and another that would be a complete measurement system for Type I diabetics using insulin. FDA suggested I make only one complete device because of their concern that I could not control the cell phone display of results. I found that the rate of change in blood glucose level was less than or equal to 5mg/dl per minute for all but three diabetics per million. That is why I chose a measurement rate for my device of 1 sample every minute. The technology I use can make a measurement every 15 seconds if required. The chart in the article indicated less frequent measurements because after five years of testing I did not record this data every minute.
Posted by: Larry Ishler | December 10th, 2009 at 12:22 pmThe next step in the process is to test a larger group of people. I have identified twenty-five different groups and I need to test at least five people in each group. This is how I would use the $100K- $200K that I need for the next step. Once I have the test protocol, I plan to review it with the FDA prior to starting testing to make sure that if the results are good I can then finish the 510K submission and get approval to market my device.
larry – i think your issue is one i’ve seen before: great brain and humanitarian heart runs up against greed (“business interests”).
count me in as another volunteer, whenever you get there.
and isn’t this the perfect opportunity for social networking to do something other than let people know what your cat just did? how about a facebook fan site (or smth similar) where people can connect, get other people connected, until there’s enough of us to push this thing into testing and then reality. ??????
Posted by: olga | December 11th, 2009 at 12:12 am- olga owens, seattle (warsawgirl @ yahoo.com)
1- This seems like the type of research that is routinely funded by the NIH SBIR Grant program. Amounts range from 100k in Phase I for 6 months to 250K per year over two tears for phase II. How have they fared in writing grants for this technology to this funding source? Was the initial data good enough to receive a grant score high enough to be initially funded? If they have not tried to write grants here, why not? That was how the research for one company’s implantable glucose sensor [Dexcom] was brought up from seedling technology at a small company in Madison Wi [Markwell Medical Institute] to become sufficiently promising that VCs picked up on it, started Dexcom, and moved it through to final product development.
2- Just because this is a single device with long-lifetime [assuming all claims presented here turn out to always be accurate] does not mean a workable revenue model is missing. Since data is processed and must be output to the user, an on/off cell phone model where say a monthly rent is charged to turn the device on could provide a revenue stream comparable to [or even more favorable than] that generated by the current strip model.
3- If this device is so good, why aren’t insulin pump companies which need a high quality sensor to close the loop jumping all over this technology? The amounts of money discussed here [under a million dollars or so] would be pocket change for Medtronic and not particularly prohibitive for even a smaller company like Insulet. The cynic in me tends to believe if they are not picking up on this, then they must see performance problems that have not been adequately addressed to this point in time.
Posted by: mcityrk | December 11th, 2009 at 3:09 amThe pharmacy industry is using Diabetes as a cash cow. We are the herd of cows they are farming. At a dollar a strip(can be done for a lot less), why would they welcome a device as described?
Posted by: Dave | December 11th, 2009 at 10:34 amI am convinced if anyone came up with a real cure for Diabetes I or II they would be in danger of losing their life to this industry. At the very least, a Doctor would be in danger of losing the license to practice medicine.
We are not alone. If someone found a real cure for Cancer I feel they would suffer a similar fate.
History has shown Polio would never have been eliminated if it hadn’t been discovered in Russia that a shot was possible to protect us against it.
The only way for this technology to advance is if it can be produced in a country without the financial predators in the Pharmacy Industry. I do not know where that would be. Possibly China or Russia might do it. But I doubt it.
This is not cynic. It is blatant. The people producing the sticks have so much money they really do not care whether anyone knows or not that they are protecting their investment in sticks vs newer technology that will not produce as much revenue.
The answer to type II is somehow undoing the trigger that closes the cell’s use of insulin down. I think part of the key is weight control. Some of the key has to be exercise. I think the danger is opening it up without changing the actual cause of the “disease”. The disease is caused by our very own bodies trying to protect us from an overabundance of glucose in our system. By closing the receptors down, it keeps us from poisoning our cells, thus causing them to react and die. So we have a double-edged sword here. If you “cure” the disease, you die. The trick is to return us to a pre-diabetic state by eliminating the basic cause of why we have gone into a type II situation. Somewhere along the way, restoring the pancreas to function normally. I suggest that anyone that even attempts this is in real danger from the FDA and the drug industry it supports. The sticks are only the tip of the iceberg. In a free economy, a cure would have been found years ago. The government and the branch FDA are not interested in curing us of anything. They are all about keeping the status quo and the money flowing to the drug companies. The free enterprise system would have toppled this monopoly on health care years ago if that were not so.
Please, I would love to voluinteer, and of course pay the cost for the prototype &c.
Posted by: Simkin | January 6th, 2010 at 6:26 pmLarry,
Please contact me. We have the resources to get you moving but we’d like to learn more.
M
Posted by: M Tindall | January 7th, 2010 at 9:19 amI am a physician and clinical researcher based in the UK.
Posted by: Dr Ali Abd | January 13th, 2010 at 5:06 amCurrently I am working with other partner to evaluate and carrying out clinical trials on non-invasive methods to measure and monitor blood glucose, we have a support from both the pharmaceutical and technology companies.
I would appreciate it if you could kindly get in touch to discuss your idea and explore the possibility of further collaboration.
Thank you
Kind regards
–
Yours faithfully
Dr Ali Abd
PhD Research Follow
1009 Level C
Royal Alexandra Hospital
Eastern Road
BN2 5BE
Would someone please invent a machine that alerts some one in the family when having a low sugar reaction, especially in the early morning after sleeping.
Posted by: Paula | January 13th, 2010 at 10:20 amThanks,
Linda
Lary,
Posted by: david | January 22nd, 2010 at 7:41 ami am from israel and ready to invest please contact me.