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Glucose Monitoring System Could Be a Game Changer

GLYSENS INC.

CEO: Joseph Y. Lucisano.

Revenue: Pre-sales, development stage. Revenues to date from research grants/contracts.

No. of local employees: 10 full-time, plus additional consultants/contractors.

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Investors: West Health Investment Fund, Windham Venture Partners, additional institutions/individuals.

Headquarters: Sorrento Mesa.

Year founded: 1998.

Company description: Privately held corporation developing a new long-term, fully implanted continuous glucose monitoring system intended to advance the standard of care in diabetes treatment by improving outcomes and lowering associated health care costs. The GlySens system automatically measures glucose for a year or more using a fully implanted sensor that is expected to require only infrequent calibration checks. Wireless transmission to an external receiver provides for convenient display, recording and alerts regarding glucose excursions.

Key factors for success: Continuous focus on end-user needs. Uses rigorous, analytical and evidence-based engineering/science approach for its product development.

Commercialization of an implantable glucose monitoring system for diabetics is looking more viable as Sorrento Mesa-based GlySens Inc. reports positive results from testing in humans and prepares for a larger scale study to begin late next year.

The GlySens implantable continuous glucose monitoring system incorporates a sensor that is located under the skin and transmits glucose measurements wirelessly to an external display device. The sensor continuously monitors the glucose levels in the subcutaneous tissue which are correlated to blood glucose levels. The accompanying display device indicates the current blood glucose level, shows a chart of the previous blood glucose values, provides adjustable automatic warnings of high and low blood glucose readings, and stores information for easy analysis by the user or physician, according to the GlySens website.

A Better Method

The implantable system, typically placed in the lower abdomen, is a leap forward from the conventional glucose monitoring method of a finger-stick, said GlySens President and CEO Joseph Y. Lucisano, and offers a longer term solution as compared with several continuous glucose monitoring products on the market that last a few days and have to be replaced.

GlySens is aiming for a one-year lifetime for its implantable system, which has been demonstrated to work for 18 months in animals. Lucisano said extensive animal testing has been done, primarily in pigs because they’re a good model for the human subcutaneous structure. The testing confirmed the device was safe, he said, and determined that the sensor is capable of operating for long periods without needing attention such as recalibration. Results have been reported in 2010 in the medical journal Science Translational Medicine.

Having transitioned to human studies, GlySens recently completed a six month pilot study with six people.

“We demonstrated that the device can operate for long periods of time without needing recalibration,” Lucisano said. “A primary goal is to deliver a product to people with diabetes that they won’t have to intervene with for maintenance. That’s a primary goal we’re very interested in satisfying.”

Lucisano said the full data set from the study is still being analyzed, but the company expects to report results — through publication or presentation within the next few months — showing the system operates similarly in humans as it does in animals.

A key to their efforts is producing a highly reliable, long-term implantable medical device, he said.

“Throughout all this time of developing a product we always tried to never lose sight of the user of the product — people with diabetes, their families and the caregivers,” said Lucisano, who cites estimates of 3 million people in the U.S. with type 1 diabetes and 4 million with type 2 diabetes. “We work very hard so that all of our science and engineering efforts are directed at meeting that need. We always keep that in the forefront and let that guide what needs to be done.”

The Next Trial

The next step is another human trial that will be conducted with several hundred subjects at multiple sites starting late next year. Results of this pivotal trial will be reported to the FDA with the aim of getting marketing clearance, although the process is expected to take several years.

Helping to shoulder the costs of developing a marketable product have been several organizations lending grant support, beginning with the National Institutes of Health’s Small Business Innovation Research grant. Others followed, including grants from the National Institute of Standards and Technology, the Juvenile Diabetes Research Foundation and the U.S. Army. Along with securing venture capital from such firms as Windham Venture Partners, GlySens recently obtained an undisclosed amount of funding from the West Health Investment Fund, a branch of locally based West Health that was seeded with $100 million from pioneering philanthropists Gary and Mary West.

Joseph Smith, chief medical and chief science officer of West Health, said GlySens offers a valuable core enabling technology that measures glucose all the time. Particularly for people with type 1 diabetes, he said one of the major concerns with insulin therapy is that they can develop hypoglycemia, or glucose levels that are too low, even while they’re asleep. With the GlySens continuous monitoring system, alarms could sound when the glucose reaches dangerously low levels and alert caregivers, he said.

Smith said GlySens’ system is a fit with West Health’s stated goal of lowering health care costs as it could potentially help avoid complications associated with managing glucose levels.

David Gough, UC San Diego bioengineering professor and co-founder of GlySens, said chronic complications of diabetes such as kidney failure, amputations, nerve damage and blindness can arise if blood glucose levels are too high, known as hyperglycemia. The condition can occur after eating a meal without adequate insulin. In the case of low blood glucose levels, or hypoglycemia, the brain is affected and people can become disoriented or pass out, which can lead to dangerous situations when driving or even cause death, he said.

Gough said researchers have taken an interest in developing a highly convenient glucose monitoring system for 40 years, and his involvement in the endeavor stretches back to the 1970s as a postdoctoral fellow at the Joslin Diabetes Center in Boston, a large diabetes clinic affiliated with Harvard Medical School.

Available options, such as sticking a finger several times a day to get a drop of blood on a strip sensitive to glucose that is measured by a small device, offers a random measurement that doesn’t convey the dynamic information of glucose fluctuations. The Hemoglobin A1C blood test measures average blood glucose values over several months, which offers clinicians a long-term picture of how well a person has controlled their blood glucose but doesn’t help on a day-to-day basis, he said.

“There are short-term disposable needlelike glucose sensors that are made by several companies and these devices are implanted subcutaneously under the skin with usually a wire or telemetry system to connect to an external display, which allows you to measure glucose that way,” Gough said. “Those devices have the obvious problem of having to insert a needle under the skin and that lasts three to seven days. It’s intended to be short-term and disposable. And you still have to finger-stick. It’s not an absolute for measuring glucose levels, it’s useful for measuring short-term trends, and you still finger-stick yourself to calibrate.”

Another approach that’s been researched is an optical method in which light shines on a body surface such as an earlobe or finger web, and using various optical methods the goal is to measure glucose without inserting anything under the skin. Although it’s an exciting alternative, Gough said it has not produced results, nor has any company made a sensor such as GlySens’ sensor.

“The target is to make a sensing method that can be used broadly by diabetics of all ages, and convenient and painless and acceptable, and that doesn’t require maintenance and doesn’t require finger-sticking to calibrate it frequently,” Gough said. “Patients wouldn’t have to be aware of the sensor. They just receive signals or receive information from their handheld device. They wouldn’t have to be involved in maintenance or recalibration related to the sensor.”

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