The implant would be able to capture the fastest excursions, or the up and down swings of blood sugar levels, although most people with diabetes have much slower excursions that could be easily followed.

"It's well within the acceptable range," he said.


To justify an implantation, the device has to have a long life. So far, the device's battery life, and the time it took for the enzymes to be consumed, was clearly greater than 500 days, Gough said.

Gough said one reason the device is implanted close to the surface of the skin is to make it easier to replace: he said it could probably be inserted during an outpatient procedure using only local anesthesia.

Short-term benefits

An actual artificial pancreas, with a monitoring system tied through a "closed loop" into an insulin pump automatically controlling insulin levels, is now being studied in clinical settings by several groups, and the sensor could be easily included. When approved, the sensor could also warn of hypoglycemia, an important concern of many diabetics.

But even without automatic feedback, the sensing device could possibly still help patients better understand their glucose levels and adjust their medication, and therefore improve their health, even if they don't use insulin pumps, Gough said.

"At present, the most widely used method for measuring glucose is finger-sticking, and the standard of care is doing that four times a day," Gough said. "But most people don't do it four times a day, and they may miss important blood glucose changes."

Blood glucose excursions create problems for diabetics in the long-term, Gough said, such as kidney damage, cardiovascular disease and diabetes-related amputations.

"This device would measure continuously," Gough said. "It would have the benefit of not needing to do blood sampling except on the rare event when recalibration is needed. The daily finger-sticking would not be needed."

Clinical trials

The next step for the product is getting U.S. Food and Drug Administration approval to start human clinical trials, Gough said.

"We anticipate it would take several years before the trials will be completed," Gough said. "It's a long-term device, so you have to test it long-term in a trial."

The research for the project is being carried out in collaboration with engineers at GlySens Inc, a 12-year-old company founded by Gough and Joseph Lucisano, a former student and a co-author on the current paper.

But the GlySens device isn't the only implantable glucose monitor in the works. In January, Bedford, Mass.-based Microchips received a $16.5 million investment to develop a long-lasting, implantable glucose-reading device.

Back to HCB News

More Industry Headlines