Abbott announced that it received European CE Mark (Conformit? Europ?ene) 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 complications1.
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.