The return of the non-invasive glucose monitor
Yesterday afternoon NIR Diagnostics Inc. (TSX Venture: NID) announced in a press release, “achieved a level of accuracy in sponsored feasibility testing of its light-based in vitro glucose monitoring device that is sufficient to advance to development of a prototype and initiate clinical trials.” The release goes to state, “Achieving results of more than 90 percent in the A zone and 99.5 percent in the A and B zone of a Clark Error Grid on a bench top device signals a technological breakthrough in the accuracy of glucose monitoring with a reagentless light-based device. No other light-based device that we know of can boast this level of glucose accuracy with components suitable for a low
cost hand-held device format,” said Ash Kaushal, Vice President Technology of NIR Diagnostics.”
Pardon Diabetic Investor if we do not jump for joy over this latest piece of news. While it is possible NIR has a truly accurate device that may one day actually reach the market Diabetic Investor remains skeptical. The list of companies who traveled this road before only to fail is long and distinguished. But this hasn’t stopped venture capitalists and investors from pouring millions of dollars into the never ending quest for a non-invasive glucose monitor.
After the many failed efforts in the mid and late 90’s it appeared that money had dried up for non-invasive companies. Just as the swallows return to Capistrano, money has returned to non-invasive glucose monitoring. Diabetic Investor is aware of multiple efforts in this area, some with notable names behind them. Besides NIR, there is GlucoLight which according to their web site is, “GlucoLight Corporation is developing a non-invasive glucose monitoring system that can be utilized as a continuous monitor in a hospital environment and ultimately as a low cost, portable monitor for use by diabetic subjects.” There’s also FoviOptics which according to their web site, “Our non-invasive system focuses on the eye while current glucose monitoring systems rely on puncturing the skin, then using blood and a test strip to produce a reading.” It should be noted that Charlie Liamos and Mark Lortz, the principals behind Therasense are involved with FoviOptics. And what about LightTouch Medical who states, “LTM scientists have developed and patented new techniques for employing Raman-based spectroscopy to read and measure blood analytes. From a competitive perspective, there is no other body of science that LTM is aware of that is currently able to achieve what LighTouch™ technology is capable of doing in a truly non-invasive manner.” Not to be out done Fluent BioMedical ands their approach, “Fluent is starting with spectroscopic techniques and signal analysis methods already well-demonstrated to predict in vivo blood glucose levels non-invasively and accurately, and adding proprietary new nanotechnology-driven optical sources, and newly enabled powerful calibration and error-checking methods, to create compact, reliable, and calibration-free systems.” Or what about OrSense, “OrSense, Ltd. has developed a non-invasive electro-optical technology that provides spot or continuous monitoring of blood constituents such as glucose, Hemoglobin (Hb), Hematocrit (Hct) and Oximetry (SpO2) using the finger as a testing site. The technology is conveniently and cost-effectively utilized in professional and home environments.” Who could forget Medoptix now known as VivoMedical and there approach, “VivoMedical is developing a patented new non-invasive glucose-monitoring technology, based on the measurements of glucose present on the skin surface. Skin surface glucose may be used to correlate to blood glucose, in a similar way that interstitial fluid (ISF) is correlated to blood glucose.” Another old company with a new name is Sensys Medical, formerly Instrumentation Metrics and their idea, “Sensys Medical is developing a blood glucose-monitoring device that uses near infrared (NIR) diffuse reflectance spectroscopy (DRS) to measure glucose levels non-invasively.”
What all these companies have in common, besides developing a non-invasive glucose monitor, is the belief by investors and venture capitalists that there is a need for a non-invasive glucose monitor. They also believe that the mere fact that patients would no longer have to prick their fingers would somehow lead to more glucose testing and better control.
Although Diabetic Investor has not seen any of the presentations these companies have made to investors or VC’s you can bet your bottom dollar they point to the epidemic growth rate of diabetes and the potentially huge market for such a device. In theory a non-invasive device makes perfect sense after all wouldn’t patients folk to such a device to avoid the “pain” associated with glucose monitoring. If this all sounds familiar it should as it’s the same theory being pushed by Pfizer (NYSE:PFE) and their inhaled insulin product Exubera. Only the pain being avoided with Exubera is the pain of daily insulin injections. Never mind there are a host of issues with Exubera, the mere fact that patients won’t have to suffer from daily insulin injections will make this a blockbuster product, or so it’s claimed by many analysts.
The fact of the matter is until patients understand what their glucose levels mean and have an action step to take based on test results, how they test is performed carries little weight. If there is one thing we have learned with the many monitors that offer alternate site testing is that the so-called pain factor of glucose testing is vastly over-rated. When alternate site testing came to market many claimed it would help increase testing frequency. Yet even with virtually pain free testing available, testing frequency has barley budged from where it was before alternate testing was approved.
These many efforts to develop a non-invasive glucose monitor is further evidence of the industry’s fascination with technology and avoids the real problem with glucose monitoring, namely a lack of patient education. All the advanced technology in the world won’t help the millions of patients with diabetes until they understand what these numbers mean and what to do with them. This fact however won’t stop investors and VC’s from their pursuit of what they believe is the “Holy Grail”. The real “Holy Grail” in diabetes is getting third party payors and managed care companies to provide adequate reimbursement for patient education. An improvement here would truly benefit the millions of patients with diabetes who then know why they should be using all this advanced technology. Until that happens the development of a non-invasive glucose monitor will be a story without a happy ending.