This is a big deal, Folks! Asante Solutions, maker of the new Snap insulin pump, just signed an agreement to make its data protocols open and available via the new open-source Tidepool Platform. This means that for the first time ever, a pump maker is going straight to the cloud, committing to an open system that will allow users to combine their pump data with CGM data and other records, and view and share that data in any app they choose!
"This is the first great example of a device maker acknowledging that a closed proprietary system is not the right way to do it," says Howard Look, CEO of Tidepool, whose work we've reported on extensively.
As our readers know, we at the 'Mine have been advocating for open data and device interoperability for many years now, and are delighted to report that Asante and Tidepool made the connection for this groundbreaking collaboration at this year's DiabetesMine Innovation Summit, where Howard gave an incredible presentation on Tidepool's mission and the work of other diabetes data and device entrepreneurs who we brought together for the first-ever DiabetesMine D-data ExChange event at Stanford the day prior to the Summit.
I encourage you all to read Asante CEO David Thrower's blog post on this new agreement, titled "The Data Is Yours," in which he explains:
"Tidepool has more work to do before this is available, but we are very excited about the future. Once Snap users can get the data from the Snap Insulin Pump into the Tidepool platform, they can then use their data to fuel other apps and dashboards. Imagine an app that uses your CGM data and the data from your Snap Insulin Pump to recommend a change to your typical breakfast that could better keep your morning BG in control. Isn't that the kind of integration that will make the management of diabetes simpler? That is just one example of the hundreds of ways that we believe our partnership with Tidepool will help make your life a little easier. In the end, that is our promise to those that use our pump. It is also the commitment of Tidepool. After all, the data is yours..."
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We spoke with both organizations for more details on how and when this new open solution will become available to interested PWDs.
"The thesis that underlies Asante is driving to simplify management of diabetes for all parties -- consumers (PWDs), also endos and educators. One of the principals is Open Data. To the degree that you have a closed ecosystem doesn't serve anyone's best interest," Thrower tells us.
He lays out the steps Asante is taking: first, creating a pump that's simple and easy to use, with super-fast "snap" prefilled-insulin-cartridge change, and "half as many steps to get to a bolus as Tandem and other pumps." Then they offer a pay-as-you-go program (like Insulet's pay model with the OmniPod) and a free four-week trial, after which you can return the pump if you don't like it. They also offer a program that allows their customers to upgrade for just $99 at any time during a four-year period -- rather than being locked in to the pump model you originally got. This will be key when Tidepool's new open data solution is ready to roll out, Thrower said.
That is, roll out depends on two pieces: an upgrade of the existing Snap pump that will be BlueTooth LE enabled for wireless data capabilities (Asante is working on that now), and Tidepool's software layer, which is also under construction. Therefore the companies don't expect to actually launch this new data option to customers for at least six months, maybe longer, depending on Tidepool's progress (see details below).
Wait a minute, doesn't Asante offer any software solution to customers now? Actually, yes. Right now users can upload Snap data to DiaSend, "but that's really more of a clinical solution than a consumer solution," Thrower says. They've also partnered with Glooko for easy data sharing with fingerstick meters. So they're clearly committed to giving patients plenty of options.
According to the news release, "Tidepool is aggressively working to establish a master file with the FDA and will be developing connectivity between the Tidepool platform and diabetes devices in 2014."
Ironically, master files are usually meant to protect trade secrets of device makers. "The notion of a software platform existing as master file for others to build on is unique, I believe. We're not aware of any others," Howard tells me.
He explains that Tidepool is just about to start a pilot study at UCSF, and is "talking early and often with FDA about the best way to get this new platform and our apps approved." Meanwhile, in full support of an open system, they've made all their source code for the Tidepool Platform and applications available to the public at https://github.com/Tidepool-org, so other developers have the opportunity to work alongside them.
Tidepool is of course hoping that Asante's move will inspire the rest of the diabetes industry to get on board. "It's fair to say we've talked to every major device maker in the U.S. — and the conversations are ongoing," Howard says.
"The thing that's great about Asante is they're the first to literally hand us their documentation and source code to integrate with our platform. It's a model that other device makers will follow," he says confidently, while admitting that Medtronic for one has so far offered only a mixed reaction. "Some folks there are very supportive (of an open data model), while other folks are not quite sure what to make of us yet," he said.
We wondered how it was possible for these companies to talk about viewing Snap pump data and CGM data in one place when the CGM makers are not yet on board? Simple answer: Tidepool has "reverse engineered" the data protocols from both Medtronic's CareLink and the Dexcom system.
"We don't technically need their support since we can create data files and USB protocols. But it would better if they'd openly support our efforts," Howard says.
Indeed, Dexcom hasn't yet made a formal announcement, but has been "very open about their support" in industry circles. At a recent Diabetes Technology Society meeting, Howard Look was on a panel with Dexcom's CTO Jorge Valdez, who grabbed the microphone at one point and stated clearly in front of 600 people something along the lines of: "We totally support open data and efforts like Tidepool's." Howard reports that the two gave each other a double-high-five right on stage.
Meanwhile, Dexcom's strategic marketing head Steve Pacelli told us in a phone interview that he "has concerns" about companies infringing on each others' intellectual property without proper agreements in place. "We're not trying to hoard data, and I'm very much in favor of an open architecture strategy... as long as it's done appropriately and safely."
We also asked Asante if they had plans for direct CGM integration with the Snap pump, as combo systems (read: artificial pancreas) are clearly the future. CEO Thrower said he can't go into too much detail on what's in the pipeline, but he hinted at a modular approach in which patients would "not be locked in to an integrated pump and CGM sensor that's a generation behind."
"Tidepool will be an enabling factor — with the ability to interact with the cloud and have options," Thrower said, adding, "We'll be less cryptic as we make more advancements."