December 9, 2002

A new hand-held device that is inserted in the ear to measure blood glucose levels may signal a future without painful finger sticks for people with diabetes, according to a study published in the December issue of the American Diabetes Association journal Diabetes Care.

The study, conducted by Drs. Carl Malchoff, associate professor, and Kamal Shoukri, assistant professor of endocrinology and metabolism at the Health Center, is the first published clinical study of the advanced prototype non-invasive blood glucose monitor.

The patented device, which was developed by Janusz Buchert, founder and president of Infratec Inc. in Wilton, isolates and measures blood glucose levels from the eardrum using the body's natural heat emission, or thermal radiation. The method and instrument are based on the discovery that natural mid-infrared body emissions change, depending on the glucose concentration of the tissue.

To achieve the reading, the device is simply placed in the ear, much like an ear thermometer, for about 10 seconds. No blood is drawn.

During the study, patients with type 1 and type 2 diabetes were tested using the device. Twenty patients were used to calibrate the monitor; six patiets were evaluated. All the testing was done at the Health Center.

Although the number of patients tested was small, the measurements from the device compared to conventional blood glucose measurements were within clinically acceptable range.

"In our tests, this truly non-invasive prototype estimated blood glucose levels with clinically acceptable accuracy," says Dr. Malchoff.

"If it can be commercially developed, this device will be more convenient, faster, safer, and certainly less painful. It will also help diabetic patients comply with the recommended blood sugar testing and not be burdened with painful finger sticks."

The technology for the prototype is different from that used by other researchers who have attempted to develop noninvasive glucose monitors. "We are utilizing a specific spectral signature of glucose emission in a thermal energy range called mid-infrared," says Buchert, "as opposed to others who have attempted to infer glucose levels from measurements in an energy range called near-infrared."

He says the technology holds the promise for other devices that could be worn like a hearing aid to permit continuous glucose monitoring or be connected to an implanted insulin pump to automaticall y control blood sugar levels.

Infratec's goal is to commercialize a portable, cell phone-sized device that will give a direct readout of the person's glucose level without need of a blood sample. The FDA clinical trials, required before the device can be approved, are expected to begin within the next two years.

The paper, "A Novel Non-Invasive Blood Glucose Monitor," by Malchoff, Shoukri, Landau, and Buchert appears in the current issue of Diabetes Care: 25.12, 2268-75, 2002. Infratec Inc., which funded the study, is a venture capital-backed company with seed financing from Access Connecticut LP and Access Investment Partners LP.