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Glucon
Announces New Clinical Study Results of Aprise™ in a Poster Presentation at
the American Diabetes Association’s 66th Scientific Sessions, in Washington,
D.C. |
Aprise is a non-invasive,
continuous blood glucose monitoring device.
Boulder, CO, June 12, 2006 --- Glucon
Inc., developer of innovative continual blood glucose monitoring devices,
announced the complete results of its recent clinical study of Aprise at the
American Diabetes Association’s 66th Scientific Sessions, in Washington, D.C.,
June 9-13, 06 The data are also published in the Scientific Sessions Abstract
Book, the June supplement to the journal Diabetes.
Dr. Ram Weiss presented Glucon’s poster, titled Non Invasive Continuous Glucose
Monitoring - Results from the First 62 Subjects. The presentation is part of the
Clinical Therapeutics/New Technology Glucose Monitoring and Sensing category,
number 408-P in the Poster Session in the Exhibit Hall. Dr. Weiss is a senior
pediatric endocrinologist at Hadassah - Hebrew University School of Medicine in
Jerusalem.
“Of the personal, non-invasive, continual blood glucose technologies currently
in development, Glucon’s Aprise is the most advanced in the clinical
investigation process,” noted Glucon’s CEO Dan Goldberger.
The analysis of the data generated by the 62 subjects included 979 pairs of
reference values and prospective, sensor derived glucose determinations. The
mean absolute relative difference (RAD) of the sample was 19.9% with a median
RAD of 13.2%. The mean and median differences were both around -5 -6 mg/dl
indicating a slight over estimation of the sensor. When all of the results were
plotted using the Clarke error grid (figure 1), 66.5%, 28.1%, 1%,4.4% and 0%
were within the A, B, C, D and E ranges respectively.
“When the three study protocols were analyzed separately, the mean RAD for the
oral glucose tolerance tests and the meal tolerance tests was superior to the
mean RAD of the glucose infusion studies (17% vs. 19% vs. 22% respectively).
Similarly, the prevalence of range D errors in the Clark error grid was smaller
in OGTTs vs. meal tolerance tests and glucose infusion studies (2.1% vs. 5% vs.
8.6% respectively),” said Dr. Weiss.
Aprise™ is intended for self monitoring diabetic patients. It is the only device
able to read blood glucose levels directly from a blood vessel, without
puncturing the skin, through the use of a novel Photoacoustic (optical and
sound-based) technology, proven to be superior to optics alone. The reading can
be updated every five minutes or faster, allowing patients to respond to real
time information. Aprise also signals when glucose levels rise or fall beyond
acceptable levels.
“The study data further supports earlier findings that Aprise performs favorably
in comparison to conventional finger stick glucose monitoring devices. We are
currently developing the next generation of Aprise, which will be even smaller,
lighter weight and comfortable to wear,” said Glucon President Ron Nagar.
About Glucon
Glucon (www.glucon.com) is developing a pipeline of automated, continual, blood
glucose (sugar) monitoring devices for home and clinical use. Glucon was founded
in 2000 by Israeli scientists including Company President Ron Nagar. The
company’s flagship product, Aprise, is currently undergoing extensive clinical
trials. Seed financing was provided by InnoMed Ventures. Additional investors
include Giza Venture Capital, Infinity Venture Capital Fund, Ascend Technology
Ventures, and several others.
Press Contact: Marjie Hadad, Media Liaison, Glucon, marjie@glucon.com or
+972-54-536-5220.
Glucon
Company Profile
May 2006
Glucon has developed two new products which will change the way blood glucose
levels are measured both at home and in the hospital: Aprise™ and OPTImus™.
Glucon’s well known consumer product in development, Aprise, is a non-invasive,
continual and real-time blood glucose monitoring device. Aprise employs a novel
Photoacoustic (optical and sound-based) technology protected by several granted
and pending patents. Aprise products will be small, light-weight and
conveniently wearable personal devices. Glucon has shown that Photoacoustics, a
unique combinatorial technology, is superior to optics alone. It provides
improved specificity (identification) and sensitivity (detection of level
changes) of the glucose measurement, by obtaining blood glucose measurements
directly from inside a peripheral blood vessel. The Company's desktop prototype
device is currently undergoing extensive clinical trials. Results to date show
accuracy levels that compare favorably to conventional invasive blood glucose
tests.
Glucon’s OPTImus is an automated, programmable, continual blood glucose
monitoring system for hospitalized patients. OPTImus will provide safer, more
efficient and cost effective blood glucose testing to support Tight Glycemic
Control (TGC) initiatives. Numerous clinical publications have shown that TGC
can significantly reduce mortality and morbidity amongst critical care patients.
The Society of Critical Care Medicine (SCCM) estimates that 28% of U.S.
hospitals have adopted TGC protocols and another 17% are in the process of doing
so.
OPTImus works with an existing vascular access point and automatically performs
a conventional blood glucose measurement. Hospital patients no longer need to
endure finger sticks and care givers no longer need to risk contact with blood
contaminated material. OPTImus can be programmed to deliver data at regular
intervals and without error. OPTImus is now being evaluated in an advanced,
international, multi-center clinical study.
Glucon was founded by Israeli scientists, led by Ron Nagar, MsC, and was
incorporated in Delaware in June 2000. The Company established a wholly owned
research and development subsidiary, Glucon Medical Ltd. in Israel in July 2000.
Company headquarters are in Boulder, CO USA.
About Diabetes
Nearly 21 million Americans and 200 million people worldwide have diabetes. One
in three people are unaware of their condition. It has also been reported that
diabetes is the only major disease with a death rate that is still rising, up 22
percent since 1990. Diabetes has additionally emerged as the leading cause of
kidney failure, blindness and non-traumatic amputation. It is also well
documented that many hospitalized patients (diabetic and non-diabetic) suffer
from stress-induced hyperglycemia. Uncontrolled high blood sugar in the hospital
can lead to an increased risk of infection, complications, length of hospital
stay, health care costs and mortality.
At present, hospitalized patients and diabetics at home utilize the conventional
finger stick blood glucose tests, which are painful, messy, and inconvenient.
Hospitalized patients treated with TGC should be tested hourly; diabetics at
home should be testing five times per day or more.
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