Would you test your blood glucose more often if it were painless and convenient? Would you be pay more for these benefits than for meters that use lancets?
Don’t stop testing with your old meter.
Literally dozens of companies are betting that millions of people with diabetes will answer yes to both questions. The race to be the first to market non-invasive—or at least minimally-invasive—blood glucose systems is nearing the final lap.
The companies use a variety of technologies that have been maddeningly complicated to develop and even to understand. But for those of us who have diabetes, the choice of technology matters less than whether it works.
It's such a high-stakes race that two companies have run into legal trouble along the way by promoting systems that do not appear to work. Ironically, these are the companies that have received the most attention, tainting the whole market.
Several companies have technologies that promise to deliver painless blood glucose testing. Some of these are so thinly capitalized that they stand little chance of finishing the race. The companies that appear to have the best chance of winning the race are those with deep pockets or major marketing partners.
Success is important both to people with diabetes and to these companies. The potential market is huge.
U.S. expenditures for blood glucose meters and supplies will be about $785 million this year, according to a report by the Frost & Sullivan market research firm. Only two-thirds of Americans with diabetes have been diagnosed, and only 18 percent of those who have been diagnosed monitor their blood glucose levels regularly, the report says.
Those numbers mean painless, hassle-free testing might help many more people with diabetes get their blood glucose under better control by testing more frequently. That's especially true for meters that promise to measure glucose levels continuously. The payoff of better control is fewer complications, according to the 1993 Diabetes Care and Complications Trial.
Work on this new generation of monitors pose a threat to manufacturers of conventional ones, especially to LifeScan, which has almost half of this market, says Frost & Sullivan Research Analyst Joon Kim. "Something has to be going on, but they are very closed mouth," he says.
LifeScan spokesperson Colleen Cox says only that the company "has been working on non-invasive technology for many years. We are committed to being the first company to introduce a non-invasive blood glucose monitoring device that is commercially viable, not necessarily the first to market one."
Almost everybody else interviewed for this article was, however, more forthcoming. Treat these announcements with caution, however, because companies sometimes use publicity to run up their stock.
That could have been the game that Biocontrol Technology and Futrex were playing. Last year Food and Drug Administration review panels recommended against approving Biocontrol's Diasensor 1000. Meanwhile, the Securities and Exchange Commission charged Futrex, developer of the so-called Dream Beam, with fraud.
Observers now write off Biocontrol and Futrex as significant players. "We know that Biocontrol's machine didn't work at all," Mr. Kim says. And it has been proven that Futrex's machine never worked either."
For Mr. Kim "the three leading horses are SpectRx, Cygnus, and Integ." He likes SpectRx and Cygnus because large companies bought rights to market their systems. He also sees "great potential" in Integ's offering, although it lacks a corporate partner.
SpectRx told the SEC that its monitor uses a laser to create micropores in the skin about the diameter of a human hair and as deep as a sheet of paper. It supposedly provides painless access to glucose-containing interstitial fluid, which correlates closely with blood glucose levels.
Last year Abbott Laboratories bought part of SpectRx and agreed to develop and manufacturer its monitor. Spokespeople for neither company offered little information beyond saying they hoped to file a premarket notification application, known as a 510(k), with the FDA next year.
Cygnus, by contrast, has publicized its GlucoWatch more widely. Its technology uses a low level of electric current to extract glucose into a pad that sits under the watch-size monitor. A noteworthy feature of the GlucoWatch is that it promises to measure glucose levels every 30 minutes around the clock. Two major companies have marketing and distribution rights to the GlucoWatch.
Mr. Kim's other leading horse, Integ, uses a proprietary interstitial fluid (ISF) technology. Its LifeGuide System uses a different technology from SpectRx product to sample glucose levels in the outermost layers of the skin.
All of these systems are minimally-invasive but painless. Another one of this type is a continuous glucose sensor that MiniMed is developing. The sensor is inside a tiny tube inserted just under the skin, says Linda "Freddi" Fredrickson, MiniMed's director of professional education and clinical services.
Only two completely non-invasive systems appear to have good prospects of finishing the race. But for one of these, CME Telemetrix, price and size are problems. With a prospective cost of $6,000 to $8,000, "it will not be a mass market device," admits Jason Hogan, director of investor relations. Its market will be clinics, doctor's offices, nursing homes, and hospitals. "It is about the size of a small briefcase," he says.
Much more promising is the Technical Chemicals and Products Inc. (TCPI) transdermal patch that draw glucose from interstitial fluid. When users place the hand-held meter over the patch, they can read their blood glucose levels.
This TD Glucose Monitoring System will be priced competitively with conventional monitors at $100, says spokesperson Howard Goldman. Patches will sell for 80 cents to a dollar each.
"We believe that we are the only company with a working non-invasive blood glucose monitoring system," he says. "By that I mean we have solved the extraction, protection, and measurement parts of the equation."
Some observers seem to agree. "TCPI appears to be further along than competing companies in the development of a totally non-invasive glucose monitoring system," says Avalon Research Group's Dr. Cathy Reese.
SmithKline Beecham is studying TCPI's system. "We are in discussions/negotiations with them, but we haven't yet got to the stage of a definitive licensing agreement," Mr. Goldman says.
The only other company planning to offer a monitor priced competitively with conventional ones kept a low profile until October. At that time Bioject Medical Technologies announced in an SEC filing that it was working with Elan Corporation to develop a product to measure interstitial fluid.
Bioject's monitor uses a patch that you wear all day, says CEO Jim O'Shea. The patch has a sensor that communicates to a wrist watch-type device that gives a continuous readout.
He says that the device will sell for about $100. Patch prices "won't be extensively more expensive than strips currently."
Commercialization of these systems is the holy grail of blood glucose testing, says Mr. Kim. They are so important to the companies working on them and to people with diabetes that one or more of them will probably be commercially available soon.
This article appeared as "The Race for a Painless Monitor" in Diabetes Wellness Letter, November 1997, pages 1-3.
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