Testing without Pain

If it didn’t hurt, would you check your blood glucose level more often? I know that I would probably check mine six or eight times a day, if it were painless.

Maybe you already use alternative sites, particularly your arm. We have fewer nerve endings there, so it seldom hurts. However, I think that my experience is typical that sometimes my arm hurts a lot when I test there. And I often end up with bruises that take days to disappear. Worse, alternative sites don’t give good readings when you need them most.

Right now the best we can do is to use as good a lancing device as we can get. Technically, the best available in the United States now is the Accu-Chek Multiclix . This is the lancing device that I use now.

While other lancing devices are spring driven, the Multiclix uses a cam for precise linear action. Theoretically, the cam action of the Multiclix is the same as its predecessor, the Softclix. But unpublished user comparisons by a competing company show that the Multiclix is less painful.

Soon, we will have several even better choices.

By the end of the year we will probably be able to buy the Pelikan Sun lancing device, which I wrote about in March. The manufacturer, Pelikan Technologies in Palo Alto, California, just introduced it in Australia, where demand for it is so great compared to the company’s manufacturing capacity that they are back ordered, even though it sells for the equivalent of US$200.

A couple of days ago I had the opportunity to meet with a senior officer of Pelikan Technologies at the 66th Annual Scientific Sessions of the American Diabetes Association. Disclosure: under contract I wrote a white paper for the company describing the advantages of the Pelikan Sun.

I also met with the top people at several companies that presented non-invasive meters at this huge convention. Eventually, it is these and other non-invasive meters that will change everything about testing for us.

Most of the enthusiasm for the new blood glucose meters is for the OTHER new type – continuous sensors. While I have written a lot about them, I came back from the ADA convention convinced that many more people will use and benefit from the forthcoming non-invasive meters.

While the continuous sensors will help us control our highs and lows better than ever before, they are expensive and not yet covered by insurance. There aren’t any non-invasive meters in production yet, but I expect that they will be in the same price range as those meters we can buy now.

Four companies presented information about their non-invasive meters at the ADA convention. They didn’t show the meters themselves. Rather, they presented posters, which are displays about 4 or 5 feet wide.

Strangely, none of these meters came from American companies. Two of the companies are Israeli, one is British, and one is Australian.

Each of these meters uses a different technology. Potentially, we might also be able to use each of them as continuous sensors.

Glucon Inc.’s CEO Dan Goldberger is in Boulder, Colorado, where I live, but the research and development is in Petach Tikva, Israel. I met with Dr. Ram Weiss, an endocrinologist at the Hadassah-Hebrew University School of Medicine in Jerusalem, who presented Glucon’s poster.

Glucon uses a technology that is both optical and sound-based for its first meter, the Aprise. This meter is not only non-invasive but also continuous, with a reading every five minutes or even less.

“Of all the personal, non-invasive, continual blood glucose technologies currently in development, Glucon’s Aprise is the most advanced in the clinical investigation process,” Goldberger claims in a separate statement.

Still, the accuracy of this and the other non-invasive meters presented at the ADA convention was less than I like. Glucon made 979 tests on 62 people with diabetes. Of these results, 66.5 percent were in zone A of the Clarke Error Grid and 28.1 percent were in zone B.

While there are newer standards, the Clarke Error Grid is still the standard most often used. Click here to see what these numbers mean. A zone A result is one where blood glucose as measured is within 20 percent to the true reading or both the true and measured readings are less than 70 mg/dl. A result within zone B won’t affect treatment or will have no effect even though the error is greater than 20 percent.

The other Israeli company presenting a non-invasive meter at the ADA convention is OrSense Ltd. in Nes Ziona, Israel. I met with CEO Lior D. Ma’ayan and Director of Research Harel Primack.

This company’s first meter, the NBM-100, uses red near-infrared occlusion spectroscopy that also can provide continuous results. These results are within zones A and B of the Clarke Error Grid 95.8 percent of the time. OrSense has submitted the NBM-100 to the Food and Drug Administration for its approval. The title of the company’s poster says that it is “highly accurate.”

The Australian company presenting a non-invasive meter at the ADA convention is AiMedics Pty Ltd. in Eveleigh, New South Wales, Australia. Dr. Nejhdeh Ghevondian, the company’s CEO explained its HypoMon device to me.

The purpose of the HypoMon is to detect the onset of hypos among people who use insulin, Dr. Ghevondian says. He indicated to me that it doesn’t have enough accuracy for more general use. In fact, its poster is the only one of these non-invasive meters that doesn’t make a Clarke Error Grid comparison.

Finally, Lein Applied Diagnostics showed its OneLook meter at this convention for the first time. I met with the company’s director, Graeme Clark. He told me that the OneLook measures the amount of glucose in the eye by shining a low-power light.

Dr. Clark presented the results of a small test of 17 volunteers. The 150 results of this test were within zone A of the Clarke Error Grid 81.3 percent of the time and within zone B 17.3 percent of the time.

You can search for each of these abstracts by poster number on the ADA’s website. Glucon’s poster is 408-P. The OrSense poster is 383-P. The AiMedics poster is 394-P. And the Lein Applied Diagnostics poster is 401-P.

For years people with diabetes have been dreaming about non-invasive meters. It was 30 years ago that an inventor won the first U.S. patent for one of these devices. That there are still none on the market and that companies are pursuing such a wide range of technologies tells me that we may still have a way to go to realize this dream.

Still, the four presentations at this year’s ADA convention are not the only non-invasive meters in the pipeline. Recently I wrote in my site about the VivoReader and VivoPatch from VivoMedical Inc. in Cupertino, California. Last year I surveyed the field. I do think that some day soon you will be using one of these non-invasive meters to test much more often without pain.

This article is based on an earlier version of my article published by HealthCentral.