Press Release
FDA Approves Abbott's FreeStyle Navigator® Continuous Glucose Monitoring System
New Tool Uniquely Provides Minute-by-Minute and Trend Information That Can
Lead to Proactive Diabetes Management
March 13, 2008
Abbott Park, Illinois (NYSE: ABT)
— The Food and Drug Administration (FDA) has approved the FreeStyle Navigator® Continuous
Glucose Monitoring System in the United States for people with diabetes.
Designed to discretely and continuously measure glucose levels through a sensor
in the back of the upper arm or abdomen, Abbott's FreeStyle Navigator system
provides minute-by-minute information about which way and how quickly blood
sugar levels are changing. This information can lead to proactive adjustments
that can result in tighter glucose ranges. Before adjusting therapy for
diabetes management based on the results and alarms from the FreeStyle
Navigator system, traditional blood glucose tests must be performed.
The FreeStyle Navigator system will be available in the second quarter of
2008 by prescription only. It received CE Mark in June 2007 and has been
available outside the United States since September 2007.
"Understanding glucose trends, with the goal of minimizing fluctuations,
is an important part of improving the management of diabetes," said
endocrinologist and Director of the International Diabetes Center Richard
Bergenstal, M.D. "We are always looking for new tools like these to enable
people with diabetes to continuously monitor their glucose levels, putting them
on the offense, not defense, so they can take action before a high or low
glucose level occurs."
For people with diabetes, less time spent with low (hypoglycemia) or high
(hyperglycemia) blood sugar has been correlated with less risk for a number of
serious short- and long-term diabetes-related complications.1 By
measuring glucose levels continuously, the FreeStyle Navigator system is
designed to provide more and better information than traditional fingerstick
glucose measurements, which can lead to improved diabetes management.
Abbott's FreeStyle Navigator system offers a number of key advances for
people with diabetes who require insulin and want to tightly manage their
disease. The system monitors glucose levels by measuring and transmitting
glucose information once per minute to the pager-sized receiver, which can be
clipped to a belt or carried in a pocket or purse. It also provides audible or
vibrating alarms before glucose levels become too high or too low, displays
five directional trend arrows to help people understand if glucose is rising or
falling, and stores historical data and glucose trend information for up to 60
days. Additionally, the sensor and transmitter are designed to accommodate
showering, swimming and a range of normal physical activities.
Clinical Trial Results
The accuracy, safety and efficacy of the FreeStyle Navigator system have
been demonstrated in two separate pivotal clinical trials, including a
five-day, in-clinic study and a study of people with type 1 and type 2
diabetes at home.
Five-Day In-Clinic Study2: Abbott conducted a study to
test the accuracy of its FreeStyle Navigator system in 58 subjects ranging in
age from 18 to 64. This study met its primary endpoint of demonstrating
accuracy over five days of wear. Using the Clarke Error Grid (CEG), comparing
readings from a lab reference to a reading from the FreeStyle Navigator
Continuous Glucose Monitoring System at a specific point in time, a combined
98.4 percent of the measurements were in the most
accurate zones, A (81.7 percent) and B (16.7 percent), which means that measurements allowed
patients to make either correct and safe treatment decisions, benign treatment
decisions, or no treatment decision at all.
Home Use Study3: In a study on the safety and efficacy of
the FreeStyle Navigator system, 123 people with type
1 and type 2 diabetes used it in their
homes for 40 days, wearing the sensor on the back of their upper arm or
abdomen. Continuous glucose values were not visible to the user during the
first half 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 participants with type 1
diabetes spent significantly less time in a hypoglycemic state (i.e., low blood
sugar) – a serious condition for this population – during the phase of the
trial when values were visible to the user. In addition, participants using a
FreeStyle Navigator system who had type 2
diabetes spent significantly less time in a hyperglycemic state. Hyperglycemia
(i.e., high blood sugar) is a serious problem, particularly for people with
type 2 diabetes.
About the FreeStyle Navigator System
The FreeStyle Navigator system is composed of three parts: a sensor, a
transmitter and a receiver. The sensor, worn for up to five days and then
replaced, is placed just under the skin and is attached to a plastic sensor
mount with adhesive to adhere to the skin, like a patch. The transmitter snaps
into the sensor mount and sends 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 delivers early-warning alarms that indicate if
glucose levels are likely to be too high or too low 10, 20 or 30 minutes in
advance. The system also stores up to 60 days worth of glucose information that
can be analyzed by the user or a health care professional.
Indicated for people ages 18 and older, the FreeStyle Navigator system is
designed to continually record interstitial fluid glucose levels for the
purpose of improving diabetes management. Readings and alarms about glucose
levels from the FreeStyle Navigator system are not intended to replace
traditional blood glucose monitoring. Before adjusting therapy for diabetes
management based on the results and alarms from the FreeStyle Navigator system,
traditional blood glucose tests must be performed.
Additional information about the FreeStyle Navigator system is available at
www.continuousmonitor.com.
About Abbott Diabetes Care
Abbott Diabetes Care, based in Alameda, California, is a leader in
developing, manufacturing and marketing glucose monitoring systems designed to
help patients better manage their diabetes. Abbott Diabetes Care is committed
to developing products to reduce the discomfort and inconvenience of blood
glucose monitoring and introducing systems that are easier to use, require
smaller blood samples and provide faster results.
Abbott Diabetes Care markets several leading-edge glucose monitoring systems
and test strips in the United States for use in both home and hospital
settings; leading brands include FreeStyle® Lite, FreeStyle Freedom™, FreeStyle
Flash® and Precision Xtra™. Additional information about Abbott Diabetes Care
may be found at www.abbottdiabetescare.com.
About Abbott
Abbott (NYSE: ABT)
is a global, broad-based health care company devoted to the discovery,
development, manufacture and marketing of pharmaceuticals and medical products,
including nutritionals, devices and diagnostics. The company employs 68,000
people and markets its products in more than 130 countries.
| 1 |
Data available from the American Diabetes Association Web
site: http://diabetes.org/diabetes-research/research-home.jsp. |
| 2 |
Study results published in the May 2007 issue of the Journal
of Diabetes Care. |
| 3 |
Data results presented in a poster (number 2-LB) entitled,
"Performance of the FreeStyle Navigator Continuous Glucose Monitoring
System During Home Use" at the 66th annual Scientific Sessions of the
American Diabetes Association. |
Media:
Catherine Bryan |
(847) 936-6722 |
Financial:
Tina Ventura |
(847) 935-9390 |
