In what its CEO Ray Krauss calls a “hotly pursued” market, GlucoLight (Bethlehem, Pennsylvania), the company he leads, last week reported its best study results to date with its continuous, noninvasive glucose monitor, the Sentris-100 — non-invasive being the key term here.

The study “yielded a number of important results” regarding the performance of the device, now in its fourth generation, the company said. The Sentris-100 is the only continuous, noninvasive blood glucose monitor for the acute care environment that is in clinical trials, according to GlucoLight. And that puts it in good shape in one of several healthcare sectors looking to avoid the frequent fingerstick blood draws required to determine glucose levels in patients.

The primary application targeted by the company is the provision of tight glycemic control in the acute care environment, and it expects ultimately to develop a device for the consumer market.

“This was our seventh clinical study,” Krauss told Medical Device Daily. “We’ve been studying humans since 2004.”

Krauss characterized this most recent study as generating “the best clinical results we’ve had — ever,” and that the company is “thrilled with the results.”

In the study, GlucoLight enrolled 10 volunteers with Type 1 diabetes mellitus.

First, researchers stabilized blood glucose levels at what the company defines as a “normal” level of 100 to 130 mg/dl. Then, it used a slow, intravenous infusion of insulin to reduce the glucose levels in those volunteers to hypoglycemic levels of about 50 mg/dl for about 30 minutes before being returned to normal levels.

Krauss in a statement said the primary objective of the study was to monitor low blood sugar in subjects with Type 1 diabetes and “show an accurate correlation to clinical chemistry testing methods.”

“I think the significant thing [about the study] is that it is the first time that we have tested low blood sugar in Type I diabetics,” Krauss said. “It’s not a test you do lightly. When you take a diabetic down to 50 milligrams, they don’t feel very good.”

However, he said that this approach is necessary to determine if a device can accurately measure glucose at low levels, calling that area “the danger zone for a diabetic.”

So, how does this noninvasive device work, exactly?

First of all, Krauss said, the Sentris-100 relies on technology optical coherence tomography technology. This involves the use of infrared light, “invisible to the human eye,” in conjunction with an interferometer, which he described as “a device that shines light to a certain depth and looks at the light that is scattered back from that specific target” and indicating the glucose level — the company’s name underlining this basic approach.

Krauss compared the use of light by the Sentris-100 to the manipulation of sound waves used in ultrasound devices. An ultrasound device, he said, “sort of steps its way through the skin and gets an echo back — then it builds a picture.”

The Sentris-100 advances infrared light in a similar fashion but, he said, in “very, very tiny steps, looking for a specific target that correlates well with glucose.

“We’ve discovered an anatomical target that is located very close to blood that serves as a surrogate for glucose measurements — the target changes shape in response to glucose,” said Krauss, who received a foundation for his work in medical device technology as a former executive at Johnson & Johnson (New Brunswick, New Jersey).

The device “hardware” consists of three primary components: an adhesive patch placed on the skin, usually on the arm, with the patch containing the necessary optics. Snapped onto the patch is a sensor, with the sensor “delivering the light to specific targets onto that lens patch.”

Additionally, the sensor is connected to a monitor by a fiber-optic cable, with the monitor representing the glucose measurement in numerical values, along with a “directional arrow” that informs the operator whether the patient’s blood glucose level is increasing or decreasing.

The source of the infrared light is contained within the monitor, Krauss said, and the device is able to scan multiple areas on the skin, automatically and without any intervention by a clinician or nurse.

In addition to a numerical value, the touchscreen monitor can provide graphical representations of glucose levels over the previous hour or the last four hours to monitor the levels over longer periods of time.

Krauss said that the first generation of the sensor was “too big to be a really useful product in the hospital ICU environment,” and so the company currently is testing a new sensor that is 75% smaller than previous models.

GlucoLight plans to perform tests with of the new sensor, with “quick feedback” expected from them, Krauss said. Then, it expects to conduct, in January, another study of the system in the ICU environment.

If all goes as planned, the company will submit a premarket application to the FDA in early 2009.

Whatever the system’s fate in the U.S., Krauss expressed confidence that the device will “certainly be on the market in Europe in 2009.”

MDD reported in March that GlucoLight, formed in 2003 to focus on blood glucose monitoring, closed on a $2 million first tranche of C-round financing (Medical Device Daily, March 22, 2007).

“We’re actively raising money now, and we’ll probably close another round of financing before Thanksgiving,” Krauss told MDD. “We’re actively raising $8 million.”

He said that amount of money should carry the company through all of the steps necessary, including pivotal trials, up to the point of submission to the FDA.