IVD Technology Magazine
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Originally published July, 1998

IVD Technology News

Challengers bring more innovation to glucose market

With some of the biggest names in health care pursuing technologies for noninvasive glucose monitoring (see IVDT Industry News, January/February 1998), it wouldn't be hard to believe that the rights to every conceivable approach have already been locked up. But smaller companies aren't shying away from the challenge, continuing to do battle for both a winning technology and a share of the market.

While promising to be painless, many of the glucose monitors now under development are not completely noninvasive. Using lasers or very small needles, they draw a sample of interstitial fluid (ISF) to assay for glucose. But this approach is drawing challengers even before a representative product hits the market.

The TD glucose monitoring system by TCPI uses disposable patches to capture ISF glucose, which is then read by a portable reflective meter. Photo Courtesy Technical Chemicals and Products.

Technical Chemicals and Products, Inc. (TCPI; Pompano Beach, FL), hopes to beat the competition to market with a truly noninvasive monitor. The company's TD glucose monitoring system is a dermal transport system in the form of a disposable patch, which users apply to their forearms for about 5 minutes for each reading.

According to Howard Goldman, TCPI's director of investor relations, the company's technology differs from those of other companies because it does not require an ISF sample. "The patch draws only glucose from the ISF present in the epidermis. Once in the patch, the glucose causes a chemical reaction that makes the patch change color." Then, a small electronic reflectance meter provides an instant glucose reading.

Although the system is operational, TCPI is currently working to develop the algorithms necessary to correlate ISF glucose measurements with venous blood levels. Goldman estimates that the company is "more than 30% of the way" toward completion of its FDA product application. Meanwhile, TCPI has entered preliminary discussions with several multinational pharmaceutical and diagnostic companies as potential marketing partners. Daiichi Pharmaceutical Co. (Fort Lee, NJ) has already signed a letter of intent for marketing rights in Japan and Taiwan.

Reflecting the competitiveness of the field, Instrumentation Metrics, Inc. (IM; Tempe, AZ), is keeping the design specifics of its glucose monitor under tight wraps. However, an IM spokesperson says the device "features a proprietary optical processing unit that uses near-infrared light and application-specific software." Touted as a platform technology for noninvasive, nondestructive testing with potential applications in a variety of other health-care and industrial fields, IM's approach seems to have caught the eye of venture capitalists. In March, the company received an investment of
$6 million from the Sprout Group, the venture capital affiliate of Donaldson, Lufkin & Jenrette (New York City), as part of a $24-million
financing.

A long-time player in the insulin-delivery field, Minimed, Inc. (Sylmar, CA), has submitted a 510(k) for its ambulatory continuous subcutaneous glucose sensor. The company's sensor is designed to be inserted into a patient's abdominal subcutaneous tissue, where it measures glucose levels every 10 seconds and records averages over 5-minute intervals. Minimed also hopes to incorporate this first-of-its-kind sensor into two noninvasive devices, one for physician-assisted monitoring and one for home-use by patients. The physician-
assistance device would be worn by the patient for three days and would store glucose-level data that the physician could upload to a computer for analysis. The home-use device would alert patients to impending hypoglycemia by sounding an alarm if glucose levels fell below a physician-determined limit. Terrance H. Gregg, Minimed president and COO, anticipates that the company will receive FDA approval for its first glucose sensor products this year.

Prototype of VMPC's retinal scanning glucose measurement device, which is still several years from the marketplace. Photo Courtesy Visionary Medical Products

One of the most innovative approaches to noninvasive glucose monitoring comes from the think tank of Visionary Medical Products Corp. (VMPC; Reno, NV). VMPC envisions patients measuring their glucose levels simply by looking into a binocular-sized device. The technology is based on the possibility of measuring glucose by the small changes it causes in the retinal capillaries of diabetics. In conjunction with scanning the retinal microvasculature, the device will also use a reflectometer to directly measure glucose levels in the aqueous humor.

Although benchtop models of the system are already available, VMPC director and designer Tom Castellano admits that "the device needs custom engineering to make it portable. Our work is mostly focused on design aspects. For both manufacture and marketing, we are looking to license the technology to another company."

VMPC is no stranger to licensing its medical products. A division of Bayer Diagnostics (Tarrytown, NY) bought the license for VMPC's "blood-glucose wristwatch," an approach to monitoring similar to that currently being developed by Cygnus, Inc. (Redwood City, CA). And Becton Dickinson (Franklin Lakes, NJ) purchased exclusive licenses for VMPC's Smartpen insulin delivery device and a combination device that integrates a Smartpen with a traditional invasive blood glucose monitor.

VMPC filed patents for its monitor in March and estimates that it will reach the market in two to four years. That timetable may put the company behind the pack, but convenience and a price tag under $1000 may win consumers. "Other systems have single-use patches that cost about a dollar each. At that rate, our monitor will pay for itself in less than a year," reasons Castellano.—Gary Woo