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Dexcom G5® Mobile Continuous Glucose Monitoring System Receives CE Mark

September 14, 2015
The Dexcom G5® Mobile Continuous Glucose Monitoring (CGM) System has received CE Mark (Conformite Europeenne) and will be available in several European countries in the coming weeks. This revolutionary new system from Dexcom will be introduced to healthcare professionals and diabetes association delegates at the European Association for the Study of Diabetes (EASD) conference in Stockholm.
The new system is the first mobile-connected CGM in the EU and is indicated for adults and children as young as two years of age. The device offers wireless Bluetooth® technology housed in the device transmitter that allows glucose information to be displayed directly onto a smart phone^ freeing users from the need to carry a separate receiver for greater convenience and discretion. Users can still use the System Receiver as an alternate display if they so choose. Dexcom G5 Mobile CGM also features Share technology that lets users select up to five designated recipients, or "followers” who can remotely monitor the patient's glucose information and receive alert notifications from almost anywhere for an added circle of support.
In addition, the new Dexcom G5 Mobile CGM system does not require confirmatory finger sticks when making treatment decisions.* The added convenience and cost savings associated with no longer performing finger sticks to verify readings on the CGM will greatly enhance the appeal of this integrated diabetes management system . The new device approved for use without confirmatory finger sticks* will initially only be made available outside of the United States.
“The Dexcom G5 Mobile CGM System lets users see and treat their diabetes in a whole new way - right on a smart device^ and without the need to perform confirmatory finger sticks for treatment decisions* – it’s dynamic glucose information when you want it and where you want it,” said Kevin Sayer, President and Chief Executive Officer of Dexcom. “With an enhanced interface and fully mobile design, the device is changing the landscape of diabetes management, offering users greater convenience, flexibility and discretion than ever before.”
The Dexcom G5 Mobile CGM System features an exceptional performing glucose sensor while providing enhanced mobility and flexibility to view and share personal glucose data and trends. Data security and confidentiality are ensured by using an encrypted Bluetooth low energy communication link and an authentication pairing process. The Dexcom G5 Mobile comes with a 7-day sensor and offers customizable alerts and a built-in low glucose alarm to provide patients with advanced warning to help them avoid dangerous high and low glucose events. Data from the Dexcom G5 Mobile can be integrated with DIASEND, a communications platform that transfers and integrates CGM data and provides retrospective reports that help patients and caregivers with overall diabetes management.
Continuous glucose monitoring is considered the most significant breakthrough in diabetes management in the past 40 years.1 The traditional standard-of-care for glucose (blood sugar) monitoring has been a finger stick meter. With the Dexcom G5 Mobile CGM System, finger stick meters are needed to calibrate the CGM. The System can be used for guidance in making therapy and meal decisions. CGM is important because, in addition to providing the glucose level, it provides the direction and rate of glucose change with the push of a button and alerts users when glucose is too low or too high. Diabetes affects about 60 million people in Europe and is on the rise, according to the World Health Organization.2 With diabetes the body cannot produce or use the hormone insulin effectively, causing a buildup of glucose, or sugar, in the blood. Obesity, physical inactivity and poor diet are risk factors for the development of diabetes.2 People with diabetes who take insulin must monitor their blood glucose levels frequently. Uncontrolled glucose can cause health complications and even death.3,4
*If your glucose alerts and readings do not match your symptoms or expectations, you should obtain a finger stick. A minimum of two finger sticks a day is required for calibration.
^For a list of compatible devices, visit References
1. Clarke SF and Foster JR. A history of blood glucose meters and their role in self-monitoring of diabetes mellitus. Br J Biomed Sci. 2012;(3)2:83-93.
2. Data and Statistics, World Health Organization Web site, Available at: Hyperglycemia (High blood glucose). American Diabetes Association Web site. Updated August 5, 2013. Accessed December 3, 2013.
4. Hypoglycemia (Low blood glucose). American Diabetes Association Web site. Updated July 16, 2013. Accessed December 3, 2013.
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