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Dexcom Gen 5 Approved Early by the FDA! Will Become Available in Late September

By Adam Brown and Alexander Wolf

Update (8/25/15): In the short time since we wrote the original story below, Dexcom has excitedly announced approval of the Gen 5 mobile CGM system! Things sure do move fast – just last week we were hoping for an approval by end of year! The Gen 5 system will begin shipping in late September (Apple iOS only for now, Android in development for early 2016). 

This system will bring CGM data straight into a paired iPhone phone app (Android version in development) via Bluetooth, eliminating the need to carry a receiver (though a receiver can still be used, if desired, since the new Gen 5 transmitter can pair with two devices). Excitingly, Dexcom disclosed that the Gen 5 will be launched for both kids and adults – a major win! 

Currently a Dexcom user? Upgrading to G5 will range from free to $299 if you own a Share receiver (depending on when it was purchased this year). If you have the prior G4 Platinum receiver without Share, you will need to go through insurance. Learn more about the G5 and upgrade pricing on Dexcom's product website here.

[Photo Credit: Dexcom, Inc.]

Original article:

While Dexcom shook up the diabetes world when it announced a notable partnership with Google, the company also shared several other very exciting future product updates in its quarterly update call – see below for our top patient highlights:

  • Dexcom is still hoping for FDA approval and launch of its Gen 5 CGM system later this year. This system will bring CGM data straight into a paired iPhone phone app (Android version in development) via Bluetooth, eliminating the need to carry a receiver (though a receiver can still be used, if desired, since the new Gen 5 transmitter can pair with two devices). Excitingly, Dexcom disclosed that the Gen 5 will be launched for both kids and adults – a major win! Already have a Dexcom G4? Don’t worry! Current G4 users (with Share) will only need to buy a new transmitter, have a remote software update of their Share receiver, and download the Apple app in order to transition to Gen 5. Those on the G4 without Share may need to get a new receiver too, though Dexcom has not announced finalized upgrade details on this front yet. The Gen 5 app has a totally redesigned look from Share, and Dexcom is making investments into new software to make CGM data even more useful.

  • Dexcom also plans to launch a “robust” new data platform by the end of the year. This platform has been developed by health data company SweetSpot, which Dexcom acquired in 2012. It’s not clear yet what this platform will look like, but Dexcom expressed that it hopes to “set a new standard” for visualization of CGM data. We hope it will include some new analysis features that make it easier to interpret CGM data, which can be overwhelming.

  • Notably, United Healthcare and Anthem are now processing CGM as a pharmacy benefit. This allows patients to pick up Dexcom sensors at retail outlets like CVS and Walgreens, just like picking up a drug prescription. In addition to convenience, this could also mean lower out-of-pocket expenses for many patients – just a co-pay (e.g., $30) instead of co-insurance (e.g., 50% of the cost). It’s possible other insurance companies may follow suit, and Dexcom hopes to have the “vast majority” of its services running through pharmacies in the future.

  • Dexcom plans to submit its Gen 6 sensor to the FDA in early 2016, potentially enabling a 2017 launch. In line with the company’s long-term goal to eliminate fingersticks, Gen 6 will likely launch with one required fingerstick calibration per day (down from the current two per day with G4). The company plans to further reduce these over time, though it is a matter of taking incremental steps with the FDA. Gen 6 will have an updated algorithm for improved accuracy/reliability.

To help keep track of all of these updates, we’ve made a table below highlighting Dexcom’s current pipeline – including other products such as its t:slim integration, Bionic Pancreas integration, and more!

Pipeline Product

Timeline

Tandem t:slim insulin pump with G4 Platinum CGM integration

 Approval announced September 9, 2015. Shipping in October.

Gen 5 system [Apple iOS Mobile app, Bluetooth transmitter, optional receiver, G4 Platinum sensor]

Approval announced August 25, 2015. Launch in late September, 2015.

Data Management platforms

- diasend

- Glooko

-SweetSpot

-Tidepool


diasend: available since 2014

Glooko: Launched in August, 2015.

SweetSpot: Launch by end of 2015.

Tidepool: Launch in coming months.

Gen 6 sensor

[New sensor with initial goal of one calibration per day]

 

FDA submission in early 2016. Potential launch in early 2017.

Insulet next-generation OmniPod with Gen 5 transmitter/smartphone app integration

2016 or beyond (following approval of next-generation PDM, which is slated to launch in 2016)

Tandem next-generation t:slim with G5 and G6 transmitter/smartphone app integration

Unknown

Bigfoot Biomedical artificial pancreas system with Gen 5 and Asante pump

Pivotal study by end of 2016.

Bionic Pancreas dual-chamber iLet with integrated Gen 5

Pivotal study 2017-2018.

Dexcom/Google “bandage” CGM

Potential launch in two to three years.

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