{"id":38157,"date":"2015-08-25T11:59:14","date_gmt":"2015-08-25T15:59:14","guid":{"rendered":"http:\/\/asweetlife.org\/?post_type=news&#038;p=38157"},"modified":"2016-12-21T07:13:43","modified_gmt":"2016-12-21T12:13:43","slug":"fda-approves-dexcom-g5-mobile-continuous-glucose-monitoring-system","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=38157","title":{"rendered":"FDA Approves Dexcom G5 Mobile Continuous Glucose Monitoring System"},"content":{"rendered":"<p style=\"text-align: justify;\"><a href=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2015\/08\/Dexcom-home.jpg\" rel=\"mfp\"><img decoding=\"async\" class=\"alignleft wp-image-38158 size-medium lazyload\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2015\/08\/Dexcom-home-300x225.jpg\" alt=\"Dexcom\" width=\"300\" height=\"225\" data-sizes=\"auto\" data-srcset=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2015\/08\/Dexcom-home-300x225.jpg 300w, https:\/\/asweetlife.org\/wp-content\/uploads\/2015\/08\/Dexcom-home.jpg 400w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/a>The\u00a0U.S. Food and Drug Administration (FDA) has approved the\u00a0Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System. With wireless Bluetooth technology built into the device transmitter, the G5 Mobile CGM System is the first and only fully mobile CGM system approved by the FDA for both adults and children as young as 2 years of age that sends glucose data directly to a smartphone, freeing users from the need to carry a separate receiver. The new transmitter securely sends vital glucose information directly to an app on iOS-enabled devices for real-time diabetes management. Android applications will follow early next year. Like its predecessor, the G4 PLATINUM CGM with Share, users can also select up to five designated recipients, or &#8220;followers\u201d. These followers can remotely monitor a patient&#8217;s glucose information and receive alert notifications from almost anywhere.<\/p>\n<p style=\"text-align: justify;\">\u00a0<\/p>\n<p style=\"text-align: justify;\">https:\/\/youtu.be\/FCfpw47nygM<\/p>\n<p style=\"text-align: justify;\">\u00a0<\/p>\n<p style=\"text-align: justify;\">\u201cDexcom is rapidly advancing technology for continuous glucose monitoring devices to improve diabetes management. Since January, the company has introduced the G4 PLATINUM CGM with\u00a0<i>Share<\/i>, apps to enable the first CGM on the Apple Watch\u00a0and now the Dexcom G5 Mobile CGM. These advances are making diabetes management more convenient and flexible than ever before,\u201d stated Kevin Sayer, President and Chief Executive Officer of Dexcom. \u201cWe are excited for the promise this new technology holds for patients and caregivers.\u201d<\/p>\n<p style=\"text-align: justify;\"><strong>About the Dexcom U.S. G5 Mobile Launch<\/strong><\/p>\n<ul style=\"text-align: justify;\">\n<li>The G5 Mobile system is anticipated to begin shipping in late September 2015.<\/li>\n<li>All purchasers of a G4 Platinum with Share system from August 1, 2015, until the G5 Mobile system is shipped, will be eligible to receive a no-cost upgrade to the G5 Mobile system.<\/li>\n<li>There will be a\u00a0<a href=\"http:\/\/www.dexcom.com\/node\/7121\">low cost cash upgrade to the G5 Mobile system<\/a>\u00a0for those patients who are still under warranty with their existing system.<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">\u201cObviously there are a lot of moving parts to our commercial launch plans given this sooner-than-expected approval, and the financial ramifications, such as inventory adjustments and revenue recognition policies are being evaluated and will be discussed in detail on the Q3-2015 earnings call in early November,\u201d remarked Sayer.<\/p>\n<p style=\"text-align: justify;\"><b>Enhanced Mobility and Flexibility<\/b><\/p>\n<p style=\"text-align: justify;\"><a href=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2015\/08\/dexcom-g5-mobile-box1-1.png\" rel=\"mfp\"><img decoding=\"async\" class=\"alignright size-medium wp-image-38159 lazyload\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2015\/08\/dexcom-g5-mobile-box1-1-300x236.png\" alt=\"Dexcom G5\" width=\"300\" height=\"236\" data-sizes=\"auto\" data-srcset=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2015\/08\/dexcom-g5-mobile-box1-1-300x236.png 300w, https:\/\/asweetlife.org\/wp-content\/uploads\/2015\/08\/dexcom-g5-mobile-box1-1.png 521w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/a>Available by prescription, the Dexcom G5 Mobile CGM System features the most accurate glucose sensor on the market while providing enhanced mobility and flexibility to view and share personal glucose data and trends. The only CGM with single digit MARD (Mean Absolute Relative Difference), the Dexcom G5 Mobile comes with the longest-wear sensor on the market and features customizable alerts and a built-in low glucose alarm (55 mg\/dL alarm) to warn patients of highs and lows and how quickly they may be happening through a simplified mobile interface. Data from the Dexcom G5 Mobile can be integrated with Dexcom CLARITYTM, a Cloud-based reporting software, for personalized, easy-to-understand analysis of trends that may improve diabetes management.<\/p>\n<p style=\"text-align: justify;\">Continuous glucose monitoring is considered the most significant breakthrough in diabetes management in the past 40 years. The traditional standard-of-care for glucose (blood sugar) monitoring has been a finger stick meter. CGM augments the use of glucose meters for the management of diabetes. Meters are still required to calibrate CGMs and 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.<\/p>\n<p style=\"text-align: justify;\">Diabetes affects 29.1 million Americans and is the 7th leading cause of death in the United States.\u00a0With diabetes, the body cannot produce or use the hormone insulin effectively, causing a buildup of glucose, or sugar, in the blood. It is estimated that approximately 86 million Americans over the age of 20 years old are at risk for developing diabetes (primarily Type 2), largely due to obesity, physical inactivity and poor diet.\u00a0People with diabetes who take insulin must monitor their blood glucose levels frequently. Uncontrolled glucose can cause health complications and even death.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration (FDA) has approved the Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System. With wireless Bluetooth technology built into the device transmitter, the G5 Mobile CGM System is the first and only fully mobile CGM system approved by the FDA for both adults and children as young as 2 years of age that sends glucose data directly to a smartphone, freeing users from the need to carry a separate receiver.<\/p>\n","protected":false},"author":131,"featured_media":38158,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1437],"tags":[115,1075,1388],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v22.9 (Yoast SEO v22.9) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA Approves Dexcom G5 Mobile Continuous Glucose Monitoring System<\/title>\n<meta name=\"description\" content=\"The U.S. FDA has approved the Dexcom G5 Mobile CGM System. 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