FDA approves Dexcom G5 Mobile CGM System that can be used to make daily diabetes treatment decisions without finger pricking. DExcom Inc.

Dexcom, Inc. announced that the FDA has approved its G5 Mobile Continuous Glucose Monitoring (CGM) system as the first and only continuous glucose monitoring system that can be used to make daily diabetes treatment decisions without finger pricking. The new �non-adjunctive� indication expands use of the Dexcom G5 Mobile CGM system as a replacement to finger stick glucose testing for diabetes treatment decisions, positioning the device as the new standard of care in glucose monitoring for diabetes management. With the new label indication, the Dexcom G5 CGM System only requires two finger pricks per day for calibration.

In July, an FDA selected panel of experts determined that the Dexcom G5 Mobile CGM system is safe, effective and the benefits outweigh the risks with the proposed indications for use. The FDA has followed the expert recommendation and made the Dexcom G5 Mobile CGM system the first and only CGM system in the U.S. to have a non-adjunctive designation. Dexcom�s CGM system is widely recognized as the most accurate and most popular CGM in the world.

Comment:Because the body�s ability to control blood sugar levels is impaired in people with diabetes, patients must regularly test and monitor their blood sugar. This is traditionally done multiple times per day by taking a blood sample from the fingertip (known as a "fingerstick" sample) and testing it with a blood glucose meter. Results indicate if glucose levels are too high (hyperglycemia) or too low (hypoglycemia), helping patients and their health care providers make appropriate diabetes management decisions. The G5 Mobile Continuous Glucose Monitoring System uses a small sensor wire inserted just below the skin that continuously measures and monitors glucose levels. Real-time results are sent wirelessly every five minutes to a dedicated receiver and a compatible mobile device (e.g., smart phone or tablet) running a mobile app. Alarms and alerts indicate glucose levels above or below user-set thresholds. The system measures glucose in fluid under the skin and must be calibrated at least two times per day using blood obtained from fingerstick tests. However, additional daily fingerstick blood tests are generally no longer necessary because unlike other continuous glucose monitoring systems, results from this device can now be used directly by patients to make diabetes treatment decisions without confirmation from a traditional fingerstick test.