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[IP] DIABETES CARE STUDY SHOWS POSITIVE RESULTS FOR DETECTING HYPOGLYCEMIA WITH THE CYGNUS GLUCOWATCH? BIOGRAPHER



My brother sent this to me. I thought it would be of interest to the list.
Susan

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                  DIABETES CARE STUDY SHOWS POSITIVE
                  RESULTS FOR DETECTING HYPOGLYCEMIA
                  WITH THE CYGNUS GLUCOWATCH?
                  BIOGRAPHER

 Frequent, non-invasive and automatic nature of the new
 device allows for more effective detection of 
hypoglycemia
than that achieved with current testing practice

 Redwood City, CA, - April 26, 2001 - (Nasdaq: CYGN) The
May 2001 issue of Diabetes Care, a prestigious, 
peer-reviewed
 journal of clinical and applied research, includes the 
research
paper entitled "Detection of Hypoglycemia with the 
GlucoWatch?
Biographer." The data presented confirms that the 
GlucoWatch
Biographer provides an important improvement over current
medical practice in detecting hypoglycemic (low blood 
sugar)
events. The GlucoWatch Biographer is the first and only
monitoring system that provides glucose readings 
automatically
and non-invasively, up to three times an hour, day or 
night, and it
received FDA approval in March.

Authors of the article were Kenneth R. Pitzer D.V.M., 
Shashi
Desai B.S., Tim Dunn B.S., Steve Edelman M.D., Yalia
Jayalakshmi Ph.D., John Kennedy B.S., Janet A. Tamada 
Ph.D.,
and Russell O. Potts Ph.D. They presented results 
demonstrating
that the GlucoWatch Biographer, with an alarm that is 
sounded in
response to glucose readings below user-selected alert 
levels, can
 improve detection of hypoglycemia over existing medical 
practice.
This could potentially make intensive therapy safer and 
more
acceptable for people with diabetes.

"These results may represent a major step forward in the
management of diabetes," notes Gerard Reach, M.D., a 
leading
French diabetes researcher and author of an editorial 
article in the
same issue of Diabetes Care. "The landmark Diabetes 
Control and
Complications Trial (DCCT) showed that improvement of
glycemic control by intensive insulin therapy drastically 
reduced
 many complications of diabetes, but increased the risk of 
severe
hypoglycemia. Therefore, an optimal monitoring system 
would
provide continuous glucose level information to people 
with
diabetes, plus be able to detect and provide a clear 
warning of
hypoglycemia. The impact of this new technology must be
estimated in terms of the metabolic control opportunities 
it
provides, along with the ability to detect severe 
hypoglycemia, and
ultimately the improved quality of life of people with 
diabetes."

Hypoglycemia causes the body to release adrenaline to 
restore
and maintain blood glucose levels by converting glycogen 
and fat
 into glucose. The conversion process may cause symptoms 
of
nervous system stimulation, such as anxiety, sweating, 
tremor,
palpitations, nausea, and pallor. Hypoglycemia can be 
brought on
by taking too much medication, missing or delaying a 
meal, eating
too little food for the amount of insulin taken, drinking 
too much
alcohol, exercising too strenuously, or any combination 
of these
factors. Hypoglycemia starves the brain of glucose energy 
and this lack of energy can cause symptoms ranging from headache 
and mild confusion to loss of consciousness, seizure, and coma.
Because many people with diabetes are familiar with the
 symptoms, they can often recognize them and treat 
hypoglycemia quickly by eating or drinking something with sugar in it. 
But a person suffering a severe hypoglycemic episode may need
emergency medical attention or have to be admitted to a 
hospital to stabilize their blood sugar level. In its most extreme 
circumstance, hypoglycemia can cause death.

Over time, many people with diabetes become insensitive 
to the warning signs of hypoglycemia and develop what is known 
as "hypoglycemia unawareness." When this occurs they have 
difficulty recognizing the symptoms of low blood sugar. This can 
create potentially dangerous situations, as the person may 
become disoriented, lose consciousness or have a seizure while 
driving or operating machinery. People with diabetes may also suffer 
from  "nocturnal hypoglycemia," a condition where they 
experience a severe hypoglycemic episode while sleeping and lapse into 
a coma if treatment is not administered quickly. Ironically, 
people who have tight control of their diabetes are more at risk for 
hypoglycemia.

 "For some people with diabetes, particularly those on 
intensive insulin regimens or prone to hypoglycemia unawareness, it 
may be appropriate to use the GlucoWatch Biographer on a routine 
daily basis," advises study co-author Steven Edelman, M.D., 
Associate  Professor of Medicine, Division of Diabetes and 
Metabolism, University of California San Diego School of Medicine and
 Veterans Affairs Medical Center, and founder of the 
non-profit  organization Taking Control of Your Diabetes?. "In other
 situations, the GlucoWatch Biographer may be most useful 
on particularly busy days when a normal routine is 
disrupted. This type of periodic use may be especially appropriate during 
travel or  changes in work shift, which can result in unpredictable 
glucose  patterns." The GlucoWatch Biographer can also be used
                  frequently during transitions in therapy, such as a new 
insulin
                  regimen and then periodically for detailed profiles.

                  "Medical experts have always told Cygnus that the value 
of
                  frequent, automatic glucose monitoring is compromised 
without an
                  effective way to detect and warn of hypoglycemia," noted 
John C
                  Hodgman, Chairman, CEO and President of Cygnus, Inc. 
"This
                  key capability of the GlucoWatch Biographer may encourage
                  more patients to work with their caregivers to embark 
upon the
                  intensive treatment regimens that have been proven to 
reduce the
                  debilitating and expensive consequences of diabetes. We 
look
                  forward to continuing our pilot marketing program and 
finalizing
                  our high capacity manufacturing capabilities that will 
ultimately lead
                  to the product's availability here in the U.S."

                  The published article reports that results from four 
clinical trials
                  were assessed to determine the effectiveness of the 
GlucoWatch
                  Biographer in detecting hypoglycemic events. The 
researchers
                  analyzed the performance of the GlucoWatch Biographer low
                  glucose alarm relative to hypoglycemia as defined by 
blood
                  glucose (BG) of less than or equal to 3.9 mmol/L (70 
mg/dL). The
                  analysis was based on 1,091 total GlucoWatch Biographer 
uses,
                  which generated 14,487 paired (GlucoWatch Biographer and 
BG)
                  readings. Results showed that the number of true positive 
(alarm
                  sounds and BG less than or equal to 3.9 mmol/L) and false
                  positive (alarm sounds but BG greater than 3.9 mmol/L) 
increased
                  as the low-glucose alert level of the GlucoWatch 
Biographer was
                  increased. However, setting the alert level from 1.1 to 
1.7 mmol/L
                  (20 to 30 mg/dL) above the level of concern helped to 
optimize
                  the trade-off between true positives and false positives 
for the
                  user. Researchers found that the same BG data analyzed 
for
                  typical monitoring practices detected fewer hypoglycemic 
events
                  than with the GlucoWatch Biographer. The results show 
that with
                  the alert threshold set at 1.1 mmol/L (20 mg/dL) above 
the target
                  level (3.9 mmol/L or 70 mg/dL), 62% of all hypoglycemic 
events
                  were detected, with only 6% false alerts. By contrast, 
only 14% of
                  hypoglycemic events were detected with the standard 
practice of
                  two finger stick measurements per day. They concluded 
that the
                  GlucoWatch Biographer's frequent and automatic readings 
allow
                  for more effective detection of hypoglycemia that that 
achieved
                  with current medical practice.

                  The innovative GlucoWatch Biographer differs from 
conventional
                  blood glucose testing devices in several ways. Worn like 
a watch,
                  it calculates, displays and stores glucose readings. It 
automatically
                  and non-invasively measures glucose collected through the 
skin,
                  not from blood, and displays glucose levels as often as 
every
                  twenty minutes, for up to twelve hours. It also creates 
an
                  "electronic diary," storing up to 4,000 values that can 
be reviewed
                  at the touch of a button, helping to detect trends and 
track patterns
                  in glucose levels. In addition, users can set personal 
glucose alert
                  levels so that an alarm sounds if readings are too high 
or too low,
                  or if readings decline rapidly. The system consists of 
two
                  integrated parts, the Biographer and the AutoSensor. The
                  Biographer is worn like a watch and calculates, displays 
and
                  stores glucose readings. The AutoSensor is a single-use
                  component that first collects and then measures the 
glucose
                  sample. The AutoSensor snaps into the back of the 
Biographer
                  and adheres to the skin, providing up to twelve hours of 
automatic
                  readings.

                  Experts agree that many people with diabetes should test 
their
                  glucose levels as often as four to seven times a day. 
However, due
                  to the pain and inconvenience of current testing methods, 
many
                  perform just a few tests each day; for example, right 
before meals,
                  possibly missing revealing information about glucose 
levels at other
                  important times, such as after meals or during sleep. The
                  GlucoWatch Biographer allows people with diabetes access 
to
                  information for potentially better-informed decisions 
about diet,
                  medication and physical activities, possibly leading to a 
better
                  quality of life and lower health care costs. The 
GlucoWatch
                  Biographer is not intended to replace the common 
"finger-stick"
                  testing method, but is indicated as an adjunctive device 
to
                  supplement blood glucose testing to provide more compl  
ete,
                  ongoing information about glucose levels.

                  Diabetes is a chronic disease characterized by the body's 
inability
                  to produce or properly use insulin, a hormone that is 
needed to
                  convert sugar, starches and other food into the energy 
needed for
                  daily life. When left untreated, diabetes can lead to 
heart disease,
                  blindness, amputation, kidney disease, dental disease, 
nerve
                  damage, sexual dysfunction and pregnancy complications. 
The
                  World Health Organization estimates there are 125 million 
people
                  worldwide with diabetes. This number has increased 15% in 
the
                  last ten years and is expected to double by 2005. In the 
U.S.,
                  approximately ten million Americans have been diagnosed 
with
                  diabetes. Diabetes is a leading cause of death in the 
U.S., and the
                  complications of uncontrolled diabetes result in an 
estimated $100
                  billion in medical costs annually. The current worldwide 
market for
                  glucose measuring products is estimated at between $3 and 
$4
                  billion, and it is expected to exceed $4.7 billion by 
2002. The U.S.
                  is estimated to account for 50-60% of all sales, while 
Western
                  Europe accounts for approximately 30%. Cygnus, Inc.,
                  headquartered in Redwood City, California, develops and
                  manufactures non-invasive diagnostic medical devices, 
utilizing
                  proprietary biosensor technologies to satisfy unmet 
medical needs
cost-effectively. The Company's current efforts are 
focused on the
 GlucoWatch Biographer and enhancements thereto.

This news release contains forward-looking statements
regarding future events and the future performance of the
Company that involve risks and uncertainties that may 
cause
the Company's actual results to differ materially. Such 
factors
include government approvals, commercial introduction and
market acceptance of the GlucoWatch system. Further, 
there
can be no assurance that the approvable letter from the 
FDA
will result in approval from the FDA for the GlucoWatch
Biographer. There can be no assurance that the Company 
will
be able to enter into a commercialization alliance or 
alliances
or that the Company will be able to outsource certain
commercialization capabilities for launch without a
worldwide commercialization alliance in place. There also 
can
be no assurance that, if the Company receives marketing
approval from the FDA and signs commercialization
agreements, the product can be successfully manufactured 
or
marketed. The Company refers you to the documents the
Company files from time to time with the Securities and
                  Exchange Commission, including the Company's Annual
Report on Form 10-K, Quarterly Reports on Form 10-Q and
Current Reports on Form 8-K, which contain descriptions 
of
certain factors that could cause the Company's actual 
results
to differ from the Company's current expectations and any
forward-looking statements contained in this news 
release.

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