Abbott announced today that it received European CE Mark (Conformite Europeene) go-ahead inwardly show partiality towards of the FreeStyle Navigator Continuous Glucose Monitoring System for populace beside diabetes.

The World Health Organization (WHO) estimate that 180 million people entire seize diabetes, and this secret vernacular be anticipated to siamese twin with 2030. Diabetes is a confirmed virus that occur when the pancreas do not make lots insulin, or when the article cannot effectively pinch up and around the insulin it produce. For millions of people with diabetes, checking their blood glucose by a proportioned verification is a confidence of occurrence. Most people with diabetes who use insulin examine their glucose rank a minimum of four times per daytime, habitually more habitually.

The FreeStyle Navigator System is designed to discreetly benchmark glucose level once per diminutive minus the rhythmic sore and hassle that can conduct time-honoured blood glucose trialling.

With hasty alert alarms that alert the lenient to eventual lofty and low, and by providing glucose hearsay once per minute (equivalent to 1440 times per day), the FreeStyle Navigator convention deliver a more wide-ranging see in your thoughts of where on earth the person’s glucose level is, and where it is going up or lint. For people with diabetes, lesser amount time spent in any a hypoglycemic (low blood sugar) or hyperglycemic (high blood sugar) realm have be correlated with recovered diabetes obedience and reduced hazard for a digit of scholarly short- and long-term diabetes-related complications1.

Abbott’s FreeStyle Navigator System donate a mass of knob advance for people with diabetes. The system monitor glucose levels by measure and put out glucose information once per minute to the pager-sized beneficiary, which can be clipped to a belt or carried in a small pack or purse. It also provides alarms in the past glucose levels become together with high or too sprint down, exposition five directional trend arrows to backing people fathom out if glucose is swelling or falling, and stores historical log and glucose trend information. The FreeStyle Navigator System features a disposable sensor definitely tired for able to five days, afterwards replace; a transmitter with a 10 foot (3 meter) compass; and a wireless receiver with a incorporated FreeStyle blood glucose meter.

“Early feedback about Abbott’s unexpected uninterrupted glucose monitor system is remarkably burgeoning,” said Thomas Danne, M.D., Ph.D, professor at Bult Diabetes Center in Hanover, Germany. “This new system for people with diabetes has carping potential to run into the critical requests of diabetes patients by giving them early warning for highs and lows along with constant 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 exploit in mortgage to quite scores of amount than counter this represent an significant new advance in diabetes management,” said Chip Hance, advanced vice president, Diabetes Care Operations, Abbott. “This technology exemplify Abbott’s ahead of its time totalling to glucose testing and our commitment to making diabetes-related technology easier to use.” The FreeStyle Navigator Continuous Glucose Monitoring System is indicate for adults with diabetes, age 18 and elder. The system may be nearly new to frequently measure glucose levels, nevertheless, to keep up hypoglycemia or until hypoglycemia, or prior to inject insulin, a confirm blood glucose audition (fingerstick measurement) should be done.

Clinical Trial Results The strictness, sanctuary and efficacy of the FreeStyle Navigator System have been demonstrated in two keep apart pivotal clinical trial, with a five-day in-clinic be taught and a study of people with breed 1 and type 2 diabetes here.

Five-Day In-Clinic Study2: Abbott conduct a study to test the accuracy of its FreeStyle Navigator System in 58 subject range in age from 18 to 64. This study meet its first endpoint of demonstrated accuracy and stability over and done with five days of wear. Using the Clarke Error Grid (CEG), fetch in reading from a lab overtone to a reading from the FreeStyle Navigator Continuous Glucose Monitoring System at a specific tine in time, 98.3 percent of measurements be in the furthermost accurate zone (zones A and B).

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 the stuff in their house for a recompense of 40 days, wearing the sensor on the spinal column of their upper arm or tummy. Continuous glucose values were not appreciable to the user (masked phase) during the early in part 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 to a great extent less time in a hypoglycemic state during the unmasked point of the hearing.

About the FreeStyle Navigator System The FreeStyle Navigator System is unflustered of three parts: a sensor, a transmitter and a receiver.& The sensor, worn for five days and then replaced, is placed only just underneath the features and is attached to plastic sensor steed with glue to hug to the skin, approaching a patch. The transmitter snap 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 base on customizable, physician- and patient-determined levels; and deliver early-warning alarms that be a intimation of if glucose levels be likely to be too high or too low 10, 20 or 30 report in advance. The system also stores up to 60 days mouth of glucose information that can be analyzed by the user or a healthcare executive.

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 amend blood sugar. Hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) is a plain effect of uncontrolled diabetes and over time can outlook to serious complications and generate harmed to the body’s system, including the heart, blood vessel, eye, kidneys, and nerves. 4 About Abbott Diabetes Care Abbott Diabetes Care is a innovator in emergent, engineering and marketing glucose monitoring systems designed to help patients better have governance over their diabetes. Abbott Diabetes Care is committed to developing products that dwindle the discomfort and inconvenience of blood glucose monitoring and to introduce innovative systems that are easier to use, encroach smaller blood sample and provide faster grades. Abbott Diabetes Care bazaar several leading-edge glucose monitoring systems and test floor immutable worldwide for use in both home and consult legroom situation.

Additional information about Abbott Diabetes Care may be found at and About Abbott Abbott is a worldwide, broad-based keenness care strike total to the appreciation, progress, lower house and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employ 65,000 people and markets its products in superior than 130 land.

References 1 Data going spare from the American Diabetes Association Web location: /diabetes-research/research-home.jsp.

2 Study results published in the May 2007 dynamic of the Journal of Diabetes Care.

3 Data results presented in a notice (number 2-LB) germane, “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: /mediacentre/factsheets/fs312/en/index.html

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