In the not-so-distant future, people with diabetes or parents caring for type 1 kids could have more peace of mind sleeping through the night thanks to a new device Dexcom's developing.
The California company that makes continuous glucose monitors (CGMs) is creating what it calls the Dexcom Share, a sort of docking station that would allow you to set your Dex G4 Platinum receiver inside a cradle overnight and have it send your diabetes data by Bluetooth to as many as five smartphones -- even in places far away! The data could be sent to the parent of a CWD who's sleeping over at a friend's house, to a spouse of a traveling adult PWD from a hotel room in another state, or even to a health care provider if desired.
It's basically Dexcom's answer to Medtronic's MySentry, only integrated with phones for a much more powerful sharing experience. While the Medtronic device is really aimed at displaying diabetes data, the Share is aimed specifically at communicating that D-Data to others who might want or need to know.
As someone who's often found himself dropping low in the middle of the night or early morning hours while all alone in a hotel room, the Share seems like it could offer much-needed peace of mind indeed! I have a routine with my wife when I'm traveling: if I don't text or answer my phone in the morning as planned, she knows my room number and can call the hotel. But having a device that lets her see my blood sugar data for proof of my well-being? Even better!
Word is that the Dexcom Share could be submitted to the FDA for regulatory review by the end of September (yes, this year!), and so the likelihood is that if approved anytime in the near future, it would be the first mobile health device communicating diabetes data openly.
We learned the first details about the Dexcom Share in February during the company's investor relations call, where CEO Terry Gregg offered updates on the company's financials and what's in the pipeline. There's been a good amount of chatter around the D-Community on this product (and everything else Dexcom might have in the works), including forum discussions and a video interview Gregg did recently on TuDiabetes. We also heard that at the ATTD (Advanced Technology & Treatments for Diabetes) conference in February, Dexcom showed a picture of a father on a business trip in a taxi, checking his phone with a sigh of relief that his daughter's CGM reading was 150 mg/dL and nothing to worry about.
But until now, we didn't know exactly how this Dexcom Share fit into the bigger technology puzzle. And no other photos or actual descriptions of the Share have been made public, so we're excited to actually see a visual for the first time!
Gregg says the Share won't display the data on an alarm-clock-like screen at all, but rather will have radio chips built into the cradle that will receive the G4 sensor data and then forward that to a "host" cell phone nearby using Bluetooth. Then the data goes to a web-based cloud (eventually to Dexcom Sweetspot), before being beamed to as many as five "followers" that can be other smartphones in other rooms, homes, cities or... well, pretty much anywhere! Gregg says eventually he hopes Share users could put a lithium battery into the cradle and put it into a child's backpack, allowing it to be carried to school or even into the professional world for adult PWDs.
So unlike the Medtronic MySentry system that just communicates between a pump-CGM and the monitor within 50-100 feet, the Dexcom Share allows much wider distribution of your data; it's not just a "glorified alarm clock" restricted to one place as many of us see the MySentry (opinions may vary, obviously).
We were lucky to get an image (see above) of this not-yet-approved device. Gregg says they'll have more visuals displayed at the American Diabetes Association's Scientific Sessions in June.
FDA on #mhealth, Not So Fast...
Of course, the regulatory review presents its own hurdles. The FDA isn't exactly moving quickly in the world of mobile health, and it's yet to release final guidelines for device makers and consumers. That's expected in the next year, but Gregg sees potential regulatory delays ahead on that front -- especially as it relates to the Dexcom Share as it would involve a medical app running in the background on a smartphone to make this data-sharing possible.
He says the federal agency wants to ensure that diabetes data wouldn't be "corrupted" in the process of being sent from a CGM transmitter to the docking station and smartphone. Questions include: If Apple updates its operating system, would that lead to any changes in data being transmitted or viewed by a patient? And could some newly installed smartphone app somehow damage the signal between the medical device and phone? Gregg says his team at Dexcom has been talking regularly with the FDA, intensely during the past month, about these issues.
"The last thing a handset manufacturer like Android or Apple wants to do is design a specific (phone) system that the FDA would consider to be a medical device," Gregg said. "Think of Apple having the FDA show up at their doorstep with a badge, saying 'We're here to inspect you as a Class III medical device.' Apple's not going to engage in that type of design, and that's not what we want."
Of course the regulatory process on mobile health might become more clear when the agency finally releases its guidelines, but whether that happens before Dexcom submits its Share platform for review remains to be seen.
"I don't know what the final solution will be, but maybe we'll know in the next year or two?" Gregg said.
This Dexcom Share fits into the company's overall plan to gradually release new devices every couple years that are like a continued string of progressively improving technologies, Gregg says.
The newest G4 Platinum just hit the U.S. market in October. Dexcom is planning its Gen-5 sensor, the one that would bypass a receiver altogether and allow for direct communication with a smartphone, to hit the market in late 2015. So, the Dexcom Share would be the stop-gap, hopefully being released sometime in 2014 or early 2015.
Originally, this Dexcom Share concept wasn't in the company's product portfolio. But Gregg says there were three key reasons why it made sense to make it:
- the need for CWD parents and adult PWDs to have this data-monitoring capability from a distance
- they could make it for 1/10 of the price that the MySentry costs (MySentry's runs as high as $3,500 for some!)
- it served the strategic mission of getting the FDA comfortable with the idea of CGM sensor-to-smartphone interaction, alleviating concerns they might have and setting the stage for direct-to-smartphone generations to follow
Of course, whatever the system, Gregg ensures the D-Community that anyone who wants a receiver is always able to get one if they choose.
Gregg says they're also simultaneously already working to develop their G6 sensor, which would be approved for 10-14 day wear rather than the existing seven-day FDA approval Dexcom has now (and IRL, it can be worn as long as three weeks). This would be so highly accurate that it would no longer require any finger-stick calibration (!) and the mean absolute relative difference (MARD - or margin of error) between results would be in the single digits. Can you say, WOW (!) for improved accuracy? That sensor is currently in feasibility trials and the tentative timeline is sometime in 2017, but Gregg says Dexcom is working with some unnamed external partners that could possibly accelerate the timeline by a year or two (meaning we could see it as soon as 2016)!
Is there a plan reaching beyond the next four or five years, we wondered?
Well, of course. Gregg says the company's strategy is to continue developing future generations of sensors as needed, and they're looking to expand open access to the senor data on a variety of platforms.
Where's Sleeping Beauty?
We also asked about their one-time plan to make a long-term implantable sensor internally referred to under the code name "Sleeping Beauty."
Several years ago, there was talk of Dexcom creating a CGM sensor could last as long as a year. We found an investment record from a 2006 filing with the SEC published online, and also a patient-oriented report about this long-term sensor that would last for a year under the skin in the abdomen, and could then be removed and replaced by a physician during a short outpatient procedure.
But Gregg tells us that years ago, the company decided it didn't have sufficient money or resources to develop "Sleeping Beauty" as originally planned. Dexcom still owns the intellectual property for the concept, but instead of developing it the company's working to improve CGM sensor technology with each generation.
"We determined that wasn't a long-term viable product for us, and so our focus in the next few years will be on the G6, G7, G8... whatever generation we might go up to," he said. "Just not the fully-implantable sensor. I still like getting updates on her, our Sleeping Beauty, we're just not actively moving forward with that project."
Even without the implantable sensor, the new Dexcom Share may very well earn the name "Sleeping Beauty" -- as it helps scores of PWDs and CWD parents sleep more peacefully through the night.
Keep your eyes peeled for updates from us on this product following the ADA conference coming up June 21-25 in Chicago.