A noninvasive blood-glucose monitor has long been awaited. People with diabetes do not look forward to monitoring their blood glucose every day, as it involves pricking their fingers to obtain blood samples.

In some cases, alternative sites for obtaining a blood sample, such as the forearm, upper arm, base of thumb, calf or thigh, have been approved for use with certain blood-glucose monitoring systems. Though using these alternative sites is generally more comfortable than pricking a finger, a lancet needle is still needed to obtain the blood sample.

Among people with diabetes, a device (read: affordable device) that would eliminate the need to poke with a needle in order to read the blood-glucose level would be a dream come true.

Since the mid-1990s, many diagnostic companies have embarked on research and development of noninvasive or minimally invasive blood-glucose home-monitoring devices. The sheer demand for such devices worldwide was enough incentive for companies to begin their work. According to analysts, four leading companies were involved in the development of noninvasive monitors in early 1998: Cygnus, Inc.; Technical Chemicals and Products, Inc.; SpectRx, Inc.; and Integ, Inc.

By the end of 2001, only Cygnus had successfully obtained FDA approval for marketing activities in the United States, for its GlucoWatch Biographer. The GlucoWatch is a noninvasive glucose monitor worn like a watch. It provides continuous monitoring for up to 12 hours after a warm-up period and calibration to a traditional fingerstick blood-glucose result. The sensors on the device take a glucose reading on interstitial fluid every 20 minutes by pulling glucose through the skin using low electric current. However, the FDA granted marketing approval of this product in the United States only as a prescription device for adults, to be used in conjunction with the regular blood-glucose meter. This makes doctors the gatekeepers to the device.

Editor's note: As of March 2002, the GlucoWatch Biographer was not yet available.

It's 2002—What Happened to the Other Companies?

Technical Chemicals and Products (TCPI) abandoned its TD Glucose Monitoring System research in May 2001 because of insufficient funding. This announcement came after the results of its clinical study suggested that further improvements were required in the technology development. TCPI aimed to combine both transdermal and membrane-based technologies into its TD Glucose Monitoring System. The device is designed to be noninvasive, using a skin patch and an electronic meter to monitor glucose levels.

Integ was designing a device that would measure glucose levels using an infrared photometer. The company experienced difficulties in its research and development stage. It was acquired by Inverness Medical Technology, Inc., who also acquired LXN Corp. in February 2001. Inverness's diabetes care division became a wholly owned subsidiary of Johnson & Johnson in November 2001 and was structured to work with LifeScan, Inc., to market its products.

SpectRx's product development is still going strong, with the support of Abbott Laboratories/MediSense, which has purchased worldwide rights to SpectRx technology (except in Singapore and the Netherlands). SpectRx is in the process of developing a minimally invasive glucose monitor that measures glucose levels in interstitial fluids (ISF). The ISF is collected through microscopic holes cut by lasers in the dead outer layer of the skin and is then measured in a patch containing a glucose sensor.

Are the Bigger Players Joining the Search?

The bigger players took a different strategy, with most joining the search through mergers, acquisitions and marketing rights.

Johnson & Johnson acquired Inverness and is using LifeScan to market its diabetes care products. Abbott/ MediSense purchased the rights to SpectRx's technology. Bayer signed an agreement with Kumetrix, Inc., a company that is developing an electronic monitor to analyze blood glucose. The device uses a micro-needle to penetrate the skin to draw blood. Bayer has negotiated exclusive rights to evaluate Kumetrix's silicon micro-needle technology for glucose monitoring.

When Will the Noninvasive Products Come Around?

Not tomorrow! Looking at the progress of the companies involved in the development of such devices, it will take some time for them to finalize the perfect technology for their products. Furthermore, marketing the noninvasive products will also take time. Noninvasive monitors are expected to be priced higher than regular blood-glucose monitors. Hence, developing the right pricing strategy is likely to determine the products' success. Despite the seemingly high demand for blood-glucose monitors, cost is an influencing factor for many people.