Dexcom had put a bit of a Band-Aid on its mobile strategy--its prior smart device-compatible continuous glucose monitor required a separate worn transmitter and a dedicated handheld receiver.

But now the FDA has approved the first CGM system, dubbed G5, which connects an all-in-one adhesive sensor/transmitter combo directly to an app on a smart device.

The new system will launch in late September with initial compatibility with Apple's iOS; Android compatibility is slated for early next year. In the G5 iteration, there is no additional hardware to facilitate the wireless data transfer between the adhesive CGM and Dexcom's Share analytical and data sharing app, although the system can be used with a dedicated receiver instead of a smart device if the user opts to do so.

"Obviously 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," said Dexcom President and CEO Kevin Sayer in a statement.

The G5 system is a big leap forward in terms of simplicity and ease-of-use for diabetic patients. The FDA approved it for adults as well as children as young as two-years-old. Dexcom has always had an edge with younger patients, who are most receptive to cutting-edge technology and whose parents require a way to remotely monitor glucose levels. The G5, like its predecessor, the G4, enables the user to share blood glucose data with up to 5 recipients, which can include healthcare providers as well as parents and other relatives.

But CGMs typically still require twice-daily calibration via the traditional finger-stick method. Up next, Dexcom expects to start to untether its CGM from the finger stick--it expects the G6 version will require only one calibration finger stick daily and enable 10-day extended wear. It hopes to start pre-pivotal testing for that newest iteration later this year, with a pivotal study planned for shortly after and a launch planned for early 2017.

Dexcom is trying to encourage G5 adoption among its existing customers by offering a free upgrade to the G5 for those that have ordered the G4 Platinum with Share System since the start of August. In addition, it's offering a "low cost cash upgrade" to the G5 for all patients who remain under warranty for their existing Dexcom CGM system.


From FierceMedicalDevices

First and Only Fully Mobile CGM System Allows Adults and Children as young as 2 years old to Conveniently and Discreetly Monitor and Share Glucose Levels

SAN DIEGO--(BUSINESS WIRE)-- Dexcom, a leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that 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. 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 "followers." These followers can remotely monitor a patient's glucose information and receive alert notifications from almost anywhere.

"Dexcom is rapidly advancing technology for continuous glucose monitoring devices to improve diabetes management. Since January, the company has introduced the G4 PLATINUM CGM with Share, apps to enable the first CGM on the Apple WatchTM and now the Dexcom G5® Mobile CGM. These advances are making diabetes management more convenient and flexible than ever before," stated Kevin Sayer, President and Chief Executive Officer of Dexcom. "We are excited for the promise this new technology holds for patients and caregivers."

About the Dexcom U.S. G5 Mobile Launch
The G5 Mobile system is anticipated to begin shipping in late September 2015.
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.
There will be a low cost cash upgrade to the G5 Mobile system for those patients who are still under warranty with their existing system.
"Obviously 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," remarked Sayer.

Enhanced Mobility and Flexibility
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.

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.


From Nyhetsinfo

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