F is for Failure

Patient Expert

F is for Failure. Don't take it personally. I'm not talking here about you or me. I'm talking about the failure of non-invasive blood glucose meters.

Specifically, I'm talking about all the hoopla over a Reuters story from Hong Kong about an Internet group of parents children with diabetes.

Industry insiders and experts on non-invasive blood glucose monitors are awfully skeptical. One of these friends tells me that he first heard about it at a short presentation in February 2007 at the Inaugural Australia-China Biomedical Research Conference in Melbourne, Australia. At that meeting Professor Joanne Chung of the Hong Kong Polytechnic University announced that they can predict glucose levels with 85 percent accuracy using near infrared spectroscopy.

"But this has been an incredibly well-trodden path, and I'd be awfully surprised if it suddenly yields acceptable results," he told me. The claim of 85 percent accuracy - whatever that means - didn't impress him or me.

I also turned to the leading expert on non-invasive blood glucose technology, John L. Smith. When he retired from LifeScan, which makes the well-known OneTouch meters, he was the company's chief scientific officer. He then headed Fovi Optics Inc. in Santa Clara, California, which tried in vain to develop non-invasive optical blood glucose meters. John wrote a great bookabout the many non-invasive efforts.
"This uses near-infrared wavelengths of 940nm, 1310nm, and 1550nm, which have already been exhaustively investigated and found not to contain enough glucose information to give accurate results," John tells me. "Both InLight Solutions and Sensys are using much higher wavelengths with more glucose content, but neither has a commercially viable instrument."

The Hong Kong group used a statistical technique called a post-hoc correlation. But, John tells me, "it is retrospective and gives no indication of the ability to predict glucose values."

He went on to say that the wavelengths quoted in the article have been looked at many times, and only wishful thinking has produced any meaningful correlations. This was the area explored by Biocontrol and by Futrex in the ill-fated "dream beam." The idea that so few wavelengths would be required for accurate measurements shows the naivety of the investigators, he says. Studies with many more wavelengths have repeatedly failed to show clinically accurate results when the studies are conducted in a disciplined way.

"This region of the near-infrared has been exhaustively studied for making non-invasive glucose measurements," he concludes. "There have been no breakthroughs to indicate that the next group will have any greater likelihood of success than the past two dozen."

The people in Hong Kong say that their device is the state of the art and that they expect their great new device to be available in a year. We are certainly a sad lot if this pie in the sky is really the state of the art, and my advice is not to hold your breath.