If you want your Dexcom G4 continuous glucose monitor (CGM) to talk to your smartphone and be able to share real-time data from anywhere, then this recent news from the FDA is something you'll definitely be interested in.

At the end of last week, the FDA approved Dexcom's new SHARE Direct system that allows users to do just that: share their CGM data directly via mobile app, without the need for any stationary device that keeps you tethered to one place. Dexcom followed up with a news release of their own, plus a Monday conference call offering more detail.

Starting in early March, the California company will begin shipping new receivers that have built-in Bluetooth, allowing for real-time sharing of diabetes data on Apple mobile devices including the iPhone and iPod Touch.

This photo was included in a Nov. 24, 2014 filing with the FCC, but it's not 100% certain to be the final design:Dexcom SHARE Direct

Interestingly, this new receiver comes on the heels of the first-gen Dexcom SHARE product, just approved by FDA in October. That was a first-of-its-kind docking station that is plugged into the wall, and when the G4 Receiver is inserted, it transmits CGM data into the cloud, where it can be accessed and shared with up to five iDevice users. Now you can sidestep the need for that docking station altogether and just enjoy CGM data-sharing directly to the respective iDevices.

It also appears to be a move on the part of FDA to create a legally sanctioned version of the open-source Dexcom-hacked solution Nightscout/CGM in the Cloud, even while making it clear that future mHealth solutions like Nightscout are welcome and won't face overly criticial regulatory review (more on that below).

Product Deets

If you're a Dexcom user now or soon to become one, here are some tidbits you'll want to know about the new SHARE Direct:

  • Dexcom says early March is when shipping starts for this new receiver; customer service reps have told us that you unfortunately can't pre-order
  • If you purchased a SHARE cradle at any point, you get a new SHARE receiver for free
  • Or if you have bought a new G4 CGM system since January 1, 2015, you get the new SHARE receiver for free
  • If you have a current G4 receiver that's still under warranty by the time this new SHARE receiver is shipped, you can get a "low-cost" upgrade; we've heard rumors of a $199 price point, but Dexcom hasn't confirmed yet
  • Starting when this is launched in early March, all new G4 receivers shipped out will be the new Bluetooth-enabled version
  • With the exception of adding Bluetooth Low-Energy, the new receiver will be the same as the current model; Dexcom won't be updating the microUSB port or sliding cover that some of us have reported as being fragile
  • Kiddos: Yes, the new receiver is for kids as young as 2. But remember Dexcom's updated algorithm that was approved last fall? That won't be in all of these new receivers, only those for adults at this point. (Dexcom is getting ready to ask the FDA for pediatric approval on the advanced algorithm)
  • As far as data sharing, the Dexcom SHARE Direct will operate pretty much the same way as the existing cradle does, and the Dexcom apps will remain free on the Apple store
  • Dexcom says it will take some additional battery power on your iPhone, but their testing shows it isn't a drastic drain on battery life
  • It is not yet Android-compatible, but that's on the way, within 2015
Notably, the new receiver will also be compatible with Dexcom’s upcoming Gen 5 Bluetooth transmitter and iPhone mobile app. As a reminder, the Gen 5 system will allow CGM data to go straight from the on-body transmitter to an iPhone app – entirely eliminating the need for a receiver for anyone with an iPhone! The G4 Platinum SHARE receiver would then serve as a backup display for those using the Dexcom mobile app, and as a primary display for those who don’t have an iPhone (until an Android version of Gen 5 is released). Dexcom’s Gen 5 system is slated for an FDA submission by March, meaning approval could come late this year or sometime in 2016 (it’s hard to predict how long the FDA will take to review it). - See more at: http://diatribe.org/sneak-peak-dexcoms-upcoming-pipeline-cgm-data-phone-touchscreen-receiver-and-new-inserter?utm_source=diaTribe&utm_campaign=b0c2ac7dc8-diaTribe_Issue_76&utm_medium=email&utm_term=0_75cdadd67f-b0c2ac7dc8-410687181#sthash.nL2gj8hb.dpuf

Wait, so why would Dexcom launch the SHARE cradle just a few months before something more advanced that would clearly render it obsolete? Well, no ShareDirectNoCradleone could have known how fast the FDA was going to approve this supplement to the Dexcom SHARE system.

The company points out that this regulatory clearance came in less than 120 days (!), much quicker than expected. However, there were some clues that FDA is moving faster in this realm: their approval in September 2013 of new mHealth guidelines, and the many conversations they've been having on open-source data, including meeting with Nightscout developers.

During the public call on Monday, Dexcom CEO Kevin Sayer said, "This has been the plan all along. We are right where we want to be."

Indeed, this phone-connected solution has been in the works since Dexcom first unveiled its mobile health plan 4+ years ago, and it's all part of the phased process of getting to the G5 system, which will eliminate the need for a receiver completely by allowing the CGM transmitter to talk directly to a smartphone.

Note that the new SHARE receiver is designed to be compatible with the future G5 transmitter, which the company expects to file with the FDA in the coming two months, and based on FDA's recent quick movements, many believe the G5 could be approved by year's end (!)

Also note that Dexcom says this doesn't impact any existing partnerships with pump companies like Animas and Tandem to develop integrated pump-CGM systems. The Animas Vibe is now being sold with G4 tech and the Tandem t:slim-G4 combo is expected later this year, but Dexcom says those have different wireless architectures and it will be up to those companies to modify their devices for Bluetooth LE transmissions.

Paving the Way 

The bigger picture here is an important one: with this FDA-Dexcom approval, the regulatory agency actually "down-classified" this mHealth system -- deeming this type of "secondary display" as "low-to-moderate risk," despite being "novel and not substantially equivalant to any legally-marketed device."

What this means is that these types of sensor-to-smartphone solutions will no longer require premarket filings that involve longer and more detailed reviews. Dexcom or other future developers will still have to comply some special rules in place, but the process will be much easier and quicker going forward.

This is huge! Some major kudos from investment expert Bradley Merrill Thompson at Epstein Becker Green was quoted in Mobile Health News recently:

“Dexcom had to undertake undoubtedly considerable expense to put together the de novo submission, and my hat is off to Dexcom for basically blazing the way for its direct competitors to follow... Unfortunately, not many companies are so willing to subsidize their competitors.”

Last fall, Medtronic announced its plan for Guardian Mobile, a pump-CGM that offers a response to the Dexcom SHARE. At the time, MedT appeared to be just starting clinical trials, and it seemed FDA approval was probably more than a year off. But with this new FDA "de novo" classification, things may move much faster. We reached out to Medtronic, and were not surprisingly given the following generic response: 

"At this time, we don’t have any updates on the timing of future products such as Guardian Mobile. The new de novo classification process is good news for the diabetes community and we look forward to commercializing new products under the new codes that provide people with diabetes and their caregivers’ convenient options to access their diabetes health information anytime, anywhere. Medtronic is working with both consumer organizations and data management service providers in the diabetes space to enable the entire diabetes community to transform diabetes care through access to meaningful data in a safe and secure way."

Cautioning Nightscout

In its news release, the FDA also made a pretty clear reference to the CGM in the Cloud Community in words that almost seem like finger-waving or even a warning:

"Devices like the Dexcom Share were previously available through open source efforts, but were not in compliance with regulatory requirements. The Dexcom SHARE system is the first of its kind to offer a legally marketed solution for real-time remote monitoring of a patient’s CGM data."

This seems a little discouraging in light of Nightscout's in-person talks with the FDA. We can only hope this is simply meant to encourage open-source folk to keep in touch with regulators on their efforts.

Dexcom's VP of Strategy & Communications Steve Pacelli says that open-source efforts like Nightscout did play a role in validating their long-term strategy to create a direct-to-iDevice solution. {CORRECTION: the original wording here implied that Nightscout came first.}

It was also encouraging to hear Dexcom's CEO say publicly that they're be willing to work with anyone else who might offer mHealth solutions, as long as they're following the rules and meeting an unmet patient need.

"If someone else can offer something on secondary display that we can't, and it's compliant with FDA rules, we'd consider working with them," Sayer said.

Also encouraging is that Pacelli tells us at this time, there is no plan to encrypt data or charge for subscription access to CGM data. Apparently there's also nothing more to report at this time on the SweetSpot data system that may very well be tied to the future Dexcom G5 launch.

Disclaimer: Content created by the Diabetes Mine team. For more details click here.

Disclaimer

This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community. The content is not medically reviewed and doesn't adhere to Healthline's editorial guidelines. For more information about Healthline's partnership with Diabetes Mine, please click here.