Healthcare Industry News:  blood glucose monitoring 

Devices Monitoring Endocrinology Regulatory

 News Release - June 6, 2007

Abbott Receives European CE Mark Approval for FreeStyle Navigator(R) Continuous Glucose Monitoring System

ABBOTT PARK, Ill., June 6 (HSMN NewsFeed) -- Abbott (NYSE: ABT ) announced today that it received European CE Mark (Conformite Europeene) approval for the FreeStyle Navigator® Continuous Glucose Monitoring System for people with diabetes.

The World Health Organization (WHO) estimates that 180 million people worldwide have diabetes, and this number is likely to double by 2030. Diabetes is a chronic disease that occurs when the pancreas does not produce enough insulin, or when the body cannot effectively use the insulin it produces. For millions of people with diabetes, checking their blood glucose on a regular basis is a fact of life. Most people with diabetes who use insulin check their glucose level a minimum of four times per day, often more frequently.

The FreeStyle Navigator System is designed to discreetly measure glucose levels once per minute without the recurring pain and hassle that can accompany conventional blood glucose testing. With early warning alarms that alert the patient to potential highs and lows, and by providing glucose information once per minute (equivalent to 1440 times per day), the FreeStyle Navigator system provides a more complete picture of where the person's glucose level is, and where it is going -- up or down. For people with diabetes, less time spent in either a hypoglycemic (low blood sugar) or hyperglycemic (high blood sugar) state has been correlated with better diabetes management and reduced risk for a number of serious short- and long-term diabetes-related complications(1).

Abbott's FreeStyle Navigator System offers a number of key advances for people with diabetes. 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 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. The FreeStyle Navigator System features a disposable sensor that is worn for up to five days, then replaced; a transmitter with a 10 foot (3 meter) range; and a wireless receiver with a built-in FreeStyle® blood glucose meter.

"Early feedback about Abbott's new continuous glucose monitoring system is very promising," said Thomas Danne, M.D., Ph.D, professor at Bult Diabetes Center in Hanover, Germany. "This new system for people with diabetes has significant potential to meet the critical needs of diabetes patients by giving them early warnings for highs and lows along with frequent information about their glucose levels," Danne added.

"The FreeStyle Navigator System provides people with diabetes with a tremendous amount of new information that is designed to help them act in advance rather than react -- this represents an important new advance in diabetes management," said Chip Hance, senior vice president, Diabetes Care Operations, Abbott. "This technology exemplifies Abbott's innovative approach to glucose testing and our commitment to making diabetes-related technology easier to use."

The FreeStyle Navigator Continuous Glucose Monitoring System is indicated for adults with diabetes, age 18 and older. The system may be used to continually measure glucose levels, however, to confirm hypoglycemia or pending hypoglycemia, or prior to injecting insulin, a confirming blood glucose test (fingerstick measurement) should be done.

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 Study(2): 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 demonstrated accuracy and stability 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, 98.3 percent of measurements were in the most accurate zones (zones A and B).

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 used the product in their homes for a total of 40 days, wearing the sensor on the back of their upper arm or abdomen. Continuous glucose values were not visible to the user (masked phase) during the first half of the study, then glucose values were visible during the second half of the study (unmasked phase). A Clarke Error Grid (CEG) analysis demonstrated that 96.8 percent of the values were in the most accurate zones. Patients in the study with type 1 diabetes spent significantly less time in a hypoglycemic state during the unmasked phase of the trial.

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 five days and then replaced, is placed just under the skin and is attached to 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 healthcare professional.

About Diabetes

The World Health Organization (WHO) estimates that 180 million people worldwide have diabetes, a chronic disease that occurs when the pancreas does not produce enough insulin, or, when the body cannot effectively use the insulin it produces. Insulin is a hormone that regulates blood sugar. Hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) is a common effect of uncontrolled diabetes and over time can lead to serious complications and cause damage to the body's systems, including the heart, blood vessels, eyes, kidneys, and nerves.(4)

About Abbott Diabetes Care

Abbott Diabetes Care 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 that reduce the discomfort and inconvenience of blood glucose monitoring and to introducing innovative 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 worldwide for use in both home and hospital settings. Additional information about Abbott Diabetes Care may be found at http://www.abbottdiabetescare.com and http://www.abbottdiabetescare.co.uk.

About Abbott

Abbott 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 65,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com.

(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.

(4) World Health Organization (WHO) Web site: http://www.who.int/mediacentre/factsheets/fs312/en/index.html


Source: Abbott

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