Medtronic appears to be jumping on the D-Data in the Cloud bandwagon, having previewed its next-gen device -- a stand-alone CGM (continuous glucose monitor) that would communicate directly by Bluetooth with your smartphone -- at the always-flashy Health 2.0 conference in Santa Clara, CA, last week.Medtronic Guardian Mobile

The under-development product is called Guardian Mobile and it's getting ready to head into clinical trials next month -- so it'll be a while until this offering is FDA approved, and a lot could possibly change by then, we're told.

After watching Medtronic Global Marketing Program Manager Samantha Katz (a DiabetesMine Design Challenge alum) conduct an on-stage demo showing a logbook app, we were frankly confused about whether this is a whole new version of Medtronic's Guardian CGM, and whether it would be linked to their pump as is the current Medtronic 530G system.

Turns out the offering is really based around an app that will allow Medtronic's CGM sensor to communicate directly to a smartphone via Bluetooth Low Energy (iOS at first, and presumably Android later). The app will begin life as a simple data viewing and logbook tool, and evolve to become more sophisticated -- with features like data-sharing between platforms -- as it is further developed and FDA approved for new functionality, says Kevin Lee, Medtronic's senior director of CGM marketing.

"Our intention is to have a variety of offerings... For those who don't want a pump or are not ready for one, we can roll this out as a standalone product where you can use your phone as the data display, so it would ship with no receiver," Lee explains.

"There will be options in future iterations where you can use the phone as the display for both the pump and CGM. (The model) depends on what we're selling at the time of FDA approval. The current 530G system available now does not talk to a phone."

This will be the first Medtronic diabetes product to use Bluetooth LE wireless connectivity, designed to be quicker and drain less device battery.

The initial intent to bring this out as standalone offering seems almost ironic, since Medtronic has for the past year been pushing customers hard toward their integrated pump-CGM system. They're also hard at work to bring their new CGM-pump combo device with a single cannula to market in the U.S. And now, they're going after CGM users only? Mixed messaging?

Versus Dexcom SHARE

Obviously, this is a direct response to what Dexcom has already been working on with its FDA-pending Dexcom SHARE device, a docking station that will allow the Dexcom CGM to send data into the cloud and directly to five different mobile phones, anywhere in the world.

"SHARE has a receiver that goes into a dock. Those two pieces don't exist in our system. You have only the sensor and transmitter and phone. In our first-gen mobile product there's no ability to relay data to additional devices, but we plan to add a whole host of enhancements over time," says Karrie Hawbaker of Medtronic PR.

Lee clarifies by adding: "In the beginning, it will primarily be the user looking at their own data on the phone as a display. Over time as the app gets better, it will allow the data to be sent to a server in the cloud, where it can be accessed by lots of people with the right security set up. So you could see the data of a child or loved one, in 'real-time'; the data is sent in five-minute increments."

Regarding the FDA regulatory path, Lee reminded us that apps meant to purely display data have a much lower regulatory hurdle than those utilizing data in ways that could effect therapy directly.  Therefore, newer versions of the Medtronic app might require new FDA approval. Yikes! That sounds like a hindrance to getting new versions to market quickly.

Open Data Integration?

The initial version of this app is connected to Medtronic's CareLink software, making it easier to "zap" your data into CareLink. Naturally we asked about integration with Tidepool and other data platforms, and also with other health devices: Will this be an open system?

The company is in talks with Tidepool and others about data-sharing options, but no decisions have been made yet, according to Medtronic Global Product Manager Cary Talbot.

"We have a lot of things happening in the market with Dexcom SHARE and NightScout... that's all very important," Talbot said, adding that the Tidepool and NightScout/CGM in the Cloud efforts are huge, in that they're getting regulators' attention to more carefully consider mHealth.

 

"It's clear there's a very strong interest in moving toward standards on this and methods of sharing data, both for patients and clinicians. We are having specific discussions about participating. Even though we've had a pump device on the market for 30 years, this is the age of data and we have realigned ourselves to attack that."

 

-- Medtronic Global Product Manager Cary Talbot

 

Talbot tells us their "diabetes solutions" and business units are exploring new data-sharing methods and also how to make better use of their enormous four-terabyte customer database (containing info on 117 million patient days).

"We realize we're sitting on that gold mine, and we want to allow people to use that data to best serve patients," he said.

Ugh... the "gold mine" phrasing in this case brings to mind monetary exploitation. It's our patient data, and it makes us a little nauseous to think of it being sold or used for profit.

At the same time, Medtronic does seem to be finally catching on to current patient needs here. "One of the highest two needs we have heard is for people to personally view their own data, discreetly on a device they carry every day... There are opportunities to do other things with (that data), like sharing it with clinicians or other people. Anything's possible, but it's not locked down," Talbot said.

About the Guardian Mobile App

If you want to see the on-stage demo conducted by Samantha Katz at the Health 2.0 event, go to this link and scroll into the video to 58:30 (yes, the video includes the whole hour-plus session).

 

Guardian Mobile demo - Medtronic

 

Katz gives a quick run-through of the new app. In true iPhone form, you can use your finger to trace data lines, and expand or contract the view. You can use the stored CGM data as a logbook and enter "events" like food (carbs) and insulin dosing. Plus you can set low and high CGM alerts on the phone -- with a snooze function to quiet the alarm for 10 minutes like you can with an iPhone clock alarm.

Those are neat features, but I'm still not feeling the need to manually enter other data like exercise records, when monitors like the FitBit and Jawbone are so popular. Two words: data integration, please!! (OK, that was three words)

(I also thought it was odd that in the video, everyone on the panel keeps saying Medtronic's new tech "is very exciting," yet somehow they all look and sound pretty bored.)

When we asked Hawbaker and Lee about pricing -- will this be in the cost range of a typical iOS app? -- we were told it's "too soon to say."

Clinical trials of the new smartphone-enabled sensor will begin enrolling at various yet-unnamed sites around the U.S. in November. Medtronic says they will make a public announcement in advance so interested patients will have a chance to sign up.

"MySentry was our first product in this whole connected care arena, and this is the next step," Hawbaker says. "We know people want access to CGM data on mobile devices, and that's what we are doing."

 

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