John Smith is considered one of the country's premiere experts on non-invasive glucose monitoring technology. He previously served as Vice President and Chief Scientific Officer of Johnson & Johnson's LifeScan, a world market leader in blood glucose monitoring systems. John now consults for companies pursuing noninvasive glucose methods, and for investors who fund them. He is the author of The Pursuit of Noninvasive Glucose: "Hunting the Deceitful Turkey," which is available for download here. He's actually retired and running a small winery in Northern California these days, but we were able to tap into his expertise for this year's DiabetesMine Design Challenge, and also ask him for this update:
Measurement of glucose without drawing blood or breaking the skin is often referred to as "noninvasive glucose," and has so far eluded all the determined attempts to find a workable approach. In more than thirty years of active investigation in this field, well over one hundred university, research and industrial groups have tried and failed.
To date, hundreds of millions of dollars have been invested in this pursuit, and so far, no approach has been able to bring an accurate, painless measurement for glucose to reality. Not for lack of effort, creativity, or imagination, but largely because glucose is extremely difficult to find and measure by indirect means. Many people have had the oxygen in their blood measured by a simple device that clips onto a fingertip, and wondered, "Why can't glucose be measured this easily—why do I have to stick a needle in my finger and draw blood every time I need to know blood sugar level?"
There are many reasons involving chemistry, physics, color measurement and other disciplines, but the simple answer is that, unlike blood, which conveniently changes color when oxygen is attached to it, glucose is present in the body in much lower amounts and has no color.
The easy targets, like tears, saliva and sweat, have long ago been thoroughly investigated and found lacking. Attempts to measure glucose in the eye, where transparent structures make viewing easier, are among some of the oldest and most frequently investigated. As new ideas, such as those submitted for the Diabetes Mine Design Challenge burst forth, they inspire new investigations. Entrepreneurs, whether motivated by the potential profits from a successful device or a more altruistic motive like advancing the health and longevity of people with diabetes, have taken up these ideas, raised funding, and set out to pursue the dream over and over again.
A number of companies have somehow managed to survive for over fifteen years while pursuing this goal, but quite a few more have fallen by the wayside. Among the more recent dropouts are Oculir (measuring the front surface of the eye using infrared light), FoviOptics (measuring the rate of recovery of pigments in the retina), Glucon (using "photoacoustic spectroscopy," a technique invented by Alexander Graham Bell), and Sensys, which tried to use near-infrared light to measure glucose in tissue, and recently announced it was downsizing and moving its operations to the U.K.
If an idea that could succeed were discovered today, it would probably take four or five years before a device could reach the market. Extensive development and careful clinical testing are necessary to be sure that reliable results are being generated. And after the development is completed, it would take another year to comply with the necessary regulatory standards put in place by the Food and Drug Administration, which must approve any such device for sale.
Someday, somewhere, however, one of these ideas will succeed, and we will finally find the "Holy Grail" of measuring glucose without pain. Until then, we must keep trying, hoping, encouraging and supporting those who pursue this most difficult quest for the betterment of everyone with diabetes.
Many thanks, John. We know it's a tough nut to crack, and we appreciate all the researchers' hard work.