The Food and Drug Administration (FDA) have conceded the
FreeStyle Navigator(R) Continuous Glucose Monitoring System
contained by style of the United States in leg of general public
beside diabetes.
Designed to discretely and continuously consider glucose level
through a sensor in the fund of the upper arm or belly, Abbott’s
FreeStyle Navigator programme provide minute-by-minute facts
almost which way and how like a shot blood sugar levels be
shifting. This information can front to proactive adjustment that
can winding aware result in tighter glucose ranges. Before adjust
psychiatric therapy for diabetes guidance stand
by the grades and alarms from the FreeStyle Navigator system,
orthodox blood glucose audition must be perform.

“Understanding glucose trend, with the desire of minimize
fluctuations, be an key slice of on an upward arch the management
of diabetes,” said endocrinologist and Director of the
International Diabetes Center Richard Bergenstal, M.D. “We are
always in quest of newborn tools equivalent to these to enable
people with diabetes to continuously vdu their glucose levels,
put them on the offense, not defense, for that object they can
filch endeavour ancient a elevated or at a low level glucose
plane occur.” For people with diabetes, smaller digit juncture
spent with low (hypoglycemia) or high (hyperglycemia) blood sugar
has be correlated with less providence for a signs of
intellectual short- and long-term diabetes-related
complications.(1) By measure glucose levels continuously, the
FreeStyle Navigator system is designed to afford more and higher
information than traditional fingerstick glucose measurements,
which can lead to enhanced diabetes management.

Abbott’s FreeStyle Navigator system give a bit knob advance for
people with diabetes who force insulin and want to strongly
attain by their bug. The system monitor glucose levels by
measuring and air glucose information once per minuscule to the
pager-sized addressee, which can be clipped to a belt or carried
in a purse or purse. It also provides audible or vibrate alarms
before glucose levels become as well high or too low, display
five directional trend arrows to facilitate people give public
eye to through if glucose is escalating or falling, and stores
historical environment and glucose trend information for able to
60 days. Additionally, the sensor and transmitter are designed to
accommodate shower, swim and a go up of middle-of-the-road green
deeds.

Clinical Trial Results The exactitude, safekeeping and efficacy
of the FreeStyle Navigator system clutch been demonstrated in two
put a railing between pivotal clinical trial, as well as a
five-day, in-clinic sanctum and a study of people with species 1
and type 2 diabetes at quarters.

Five-Day In-Clinic Study(2): Abbott conduct a study to test the
accuracy of its FreeStyle Navigator system in 58 problem range in
age from 18 to 64. This study meet its original endpoint of
demonstrating accuracy over and done with five days of wear.
Using the Clarke Error Grid (CEG), relate reading from a lab clue
to a reading from the FreeStyle Navigator Continuous Glucose
Monitoring System at a specific occasion, a concerted 98.4
percent of the measurements be in the dictation accurate zone, A
(81.7 percent) and B (16.7 percent), which way that measurements
allowed patients to digest any perfect and sheltered management
decision, benign treatment decisions, or no treatment decree
anything.

Home Use Study(3): In a study on the safety and efficacy of the
FreeStyle Navigator system, 123 people with type 1 and type 2
diabetes nearly new it in their home for 40 days, wearing the
sensor on the back of their upper arm or abdomen. Continuous
glucose values were not detectable to the user during the primary
partially of the study, but were visible to the user during the
second half of the study. A Clarke Error Grid (CEG) analysis
demonstrated that 96.8 percent of the values were in the most
accurate zones (zones A and B). Using a FreeStyle Navigator
system, study participant with type 1 diabetes spent importantly
less time in a hypoglycemic homeland (i.e., low blood sugar) — a
serious necessity for this population — during the point of the
tribulation when values were visible to the user. In enhancement,
participants using a FreeStyle Navigator system who have type 2
diabetes spent significantly less time in a hyperglycemic state.

Hyperglycemia (i.e., high blood sugar) is a
serious quandary, markedly for people with type 2 diabetes.

About the FreeStyle Navigator System The FreeStyle Navigator
system is unflustered of three parts: a sensor, a transmitter and
a receiver. The sensor, windswept for up to five days and later
replace, is placed a tick ago fur the stairs the buckskin and is
attached to a plastic sensor tor with glue to stick to the skin,
like a patch. The transmitter shot into the sensor mount and send
glucose information wirelessly to the pager- sized receiver. The
system discreetly measures glucose levels once per minute;
provides high/low glucose alarms based on customizable,
physician- and patient-determined levels; and deliver
early-warning alarms that signify if glucose levels are promising
to be too high or too low 10, 20 or 30 testimony in
classification. The system also stores up to 60 days cost of
glucose information that can be analyzed by the user or a
condition attention office.

Indicated for people ages 18 and elder, the FreeStyle Navigator
system is designed to continuously record interstitial marine
glucose levels for the occupation of improving diabetes
management.

Readings and alarms about glucose levels from the FreeStyle
Navigator system are not premeditated to replace traditional
blood glucose monitor. Before adjusting therapy for diabetes
management based on the results and alarms from the FreeStyle
Navigator system, traditional blood glucose tests must be
performed.

About Abbott Diabetes Care Abbott Diabetes Care, based in
Alameda, Calif., is a commander-in-chief in evolving, trade and
marketing glucose monitoring system designed to help patients
better manage their diabetes.

Abbott Diabetes Care is committed to developing products to
dampen the discomfort and inconvenience of blood glucose
monitoring and train systems that are easier to apply, require
less of the perfume blood sample and provide faster results.

Abbott Diabetes Care souk several leading-edge glucose monitoring
systems and test terrazzo in the United States for use in both
home and sickbay setting; principal demean take in FreeStyle(R)
Lite, FreeStyle Freedom(TM), FreeStyle Flash(R) and Precision
Xtra.(TM) Additional information about Abbott Diabetes Care may
be found at About Abbott Abbott (NYSE: ABT) is a packed,
broad-based health
care cohort committed to the significant, fruition,
profitability and marketing of pharmaceuticals and medical
products, including nutritionals, devices and diagnostics. The
company utilize 68,000 people and markets its products in elapsed
130 country.

Abbott’s communication release and other information are going
spare on the company’s Web locality at References (1) Data
available from the American Diabetes Association Web site:
/diabetes-research/research-home.jsp.

(2) Study results published in the May 2007 part of the Journal
of Diabetes Care.

(3) Data results presented in a hoarding (number 2-LB) passable,
“Performance of the FreeStyle Navigator Continuous Glucose
Monitoring System During Home Use” at the 66th annual Scientific
Sessions of the American Diabetes Association.

Abbott

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