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

Innovation 2015

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° nbg-glucose-monitorKelvin (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.

nbg-glucose-graphs

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.nbg-non-invasive-glucose-monitor

"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??}

Disclaimer: Content created by the Diabetes Mine team. For more details click here.

Disclaimer

This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community. The content is not medically reviewed and doesn't adhere to Healthline's editorial guidelines. For more information about Healthline's partnership with Diabetes Mine, please click here.