Cygnus aims to begin clinicals with non-invasive OTC blood glucose monitor in mid-1996.

CYGNUS THERAPEUTICS' NONINVASIVE BLOOD GLUCOSE MONITOR is expected to enter clinical trials by mid 1996, the company estimated. The wrist watch-type device, based on reverse iontophoresis technology, is still in preliminary stages of development and a clinical protocol for the study has not yet been designed. The study is expected to compare Cygnus' noninvasive device to a standard OTC blood glucose monitor that uses the finger-prick technique.

Cygnus does not expect that FDA will require an investigational device exemption for the study. The company plans to discuss clinical requirements with the agency after the protocol is finalized.

The prototype device, which the company is calling Gluco-Watch, is intended to be worn continuously by the patient, painlessly drawing glucose out of the skin and into a patch contained in the device.

Describing the reverse iontophoresis technology at a symposium held July 31-Aug. 1 in Seattle sponsored by the International Society on Controlled Release of Bioactive Materials, Cygnus researcher Janet Tamada explained that it involves the transmission of an iontophoretic current that "induces electro-osmotic flow" which, in turn, "enhances transport of glucose across the skin" and into the patch. Cygnus has an exclusive license to the technology, which was developed by a team of researchers led by Richard Guy at the University of California, San Francisco.

In addition to the daily patch, which will be attached to both the individual's skin and the monitor, the device will include: a glucose meter to analyze the patch sample; a "mode button" designed to activate the monitor and display the glucose reading; a data storage capability; and an alarm mechanism to alert the individual of extremely high or low glucose levels. Cygnus plans to manufacture the pad component that will collect the glucose samples. The remaining components of the device will be subcontracted out to other diagnostic product manufacturers.

The device will be designed to provide a glucose reading every half-hour when the mode button is activated. In addition, the readings will be stored by the device so that they can be referenced later by a patient or physician.

Highlighting the health need for such a monitor, Cygnus cited an American Diabetes Association recommendation that intensive and frequent monitoring of blood glucose levels results in a "delay in the onset and a major slowing of the progression" of complications in patients with Type I diabetes (insulin-dependent diabetes mellitus). The ADA recommendation came as a result of findings from the Diabetics Care and Complications Trial. Cygnus said that many diabetics fail to follow ADA's advice because current glucose monitors involve the drawing of blood.

Cygnus' technology takes a different approach from light-based noninvasive glucose monitors. One company developing a monitor based on near-infrared light, Biocontrol Technologies, has a 510(k) premarket notification application pending with FDA for its Diasensor 1000 device.

Eventually, the noninvasive blood glucose monitoring device may be linked to an automatic insulin dispensing system. Research on one such method under development, ultrasound-mediated transdermal protein delivery, is reported in the Aug. 11 issue of Science magazine. Cygnus is not affiliated with the study and has no plans to develop a product that would use the ultrasound technology.