Continuous glucose monitoring leader Dexcom on Tuesday announced a major (some may even say historic!) advancement in enabling open, accelerated innovation in data-driven diabetes tools: the San Diego company became likely the first-ever major FDA-approved medical device provider to launch a public application programming interface (API) – as opposed to the proprietary, closed data platforms used by most med/tech companies. 

This essentially “breaks open” a path for collaborative innovation with the patient community, by making the API and Dexcom-certified CGM data available for thousands of third-party programmers to unleash their creativity on building a variety of new tools.

As of Tuesday, any and all developers in the U.S. can register at https://developer.dexcom.com – the collaborative hub that we’re proud to say was first unveiled at our very own Fall 2016 DiabetesMine D-Data ExChange event at UCSF’s Mission Bay biotech center.

The other exciting news is that Dexcom is launching with seven initial developer partners, each bringing new and improved mobile apps made far more powerful by their access to CGM data: App Practice, Evidation Health, Ensa, Nutrino, One Drop, Rimidi, and Tidepool.

Nutrino, for example, can now better help patients see the relationship between their diet and glucose behavior; Rimidi can offer “a new set of clinician capabilities”; and One Drop will be able to weave CGM data into its coaching offerings. App Practice will enable better conversations with CGM users and EHR integration; and Ensa is a brand new app co-launching this week that will combine fitness accelerometer data with CGM data, using Artificial Intelligence.

“The most important message is that there’s now a lot more choice in where people want their data to go,” Dexcom CEO Kevin Sayer tells us. “We realized we just can’t do everything better than everybody else. Some people have ideas for better solutions to expand capabilities combined with Dexcom data that will improve diabetes care. We think that’s really important.”

He also notes that patients will no longer need to wait on one team of developers to create a tool, as open access to Dexcom’s API for patient-approved CGM data retrieval allows “catalyzing innovation across many.”

 

Speaking of Not Waiting

A core rally cry of the #WeAreNotWaiting do-it-yourself diabetes tech movement from the beginning has been calling on industry players to PLEASE OPEN THEIR APIs... to allow access to the backend tech that enables anyone with developer skills to freely build on their platform (without having to spend time and energy hacking their way in). The folks in the Nightscout/CGM in the Cloud and OpenAPS communities should be toasting champagne right about now!

Seriously, even if you're not a self-proclaimed techie or active part of the #WeAreNotWaiting DIY community, you should be happy about this announcement. Here's why:

Along with last week's announcement that a Korean insulin pump company is the first to offer two-way communication capabilities built into its product to allow tech-savvy users to tinker with it, what we're experiencing is the dawn of A New Era of Industry Embracing Patient Innovation.

That means people living with this illness -- along with consumer companies and anyone with skills and a great idea -- are for the first time being invited to participate in the innovation process to create the kind of tools and features that we know we need in real life!

We've come a very long way from the early days of Nightscout/CGM in the Cloud, when Dexcom leaders initially bristled at the idea of users meddling with their technology and reverse-engineering the protocols to allow developer access. I remember personally getting on the phone with Kevin Sayer and reminding him that having such a passionate and active user base is a gift, that ought to be embraced and nurtured.

We have to give the company huge props for orchestrating a complete 180, eventually announcing last Fall at the #Ddata16 forum their goal to “create a developer ecosystem” around their user data, and broaden the range of data availability. Then-newly-hired Senior VP of Data Annika Jimenez said the company "pictures a near-future world where many third-party apps” will run off Dex data, and ended her talk by inviting anyone tech-savvy enough to build an app to come, “Make better lives with us.”

And now they've fully delivered on that promised sandbox!

 

The Nuts and Bolts

Here’s how it all works, in our own self-compiled Q&A, based on information provided by Sayer and Jimenez:

DM) Is this Dexcom developer platform open to the public?

Dexcom) Yes, we initially did a limited launch in beta form, and it’s now released publicly. We already have seven partners going live with full production data, that is of course all patient-authorized. We think it’s a pretty cool place to immerse yourself in all things Dexcom data.

Are there any constraints on the data being provided?

It’s all there with user permission, of course. Due to current FDA restraints, this is still limited to data that is at least three hours old -- not real-time – because that’s what they consider the threshold between ‘live display’ and retrospective data. The idea is that no one is going to make current therapy decisions on three-hour-old data. 

What exactly is FDA’s role in this? Did the open portal require approval?

This is considered a Class 1, 510K-exempt medical device. Therefore it was filed with FDA, but did not require submission and approval duration like with a Class 2 or 3 product.

That said, it is different from apps and APIs in the general wellness space, because as a medical device company, we’re heavily governed by the FDA quality process, requiring full documentation and adherence to compliance rules.

But the FDA did not cause a delay here; Courtney Lias and Stayce Beck have been nothing but supportive and enthusiastic.

We do think this will help pave the way for other companies that may want to go the same route, and of course for additional partners. We have a strong pipeline lined up, into Q4 and beyond – and are excited about adding more partners over time, which you’ll find in the developer portal gallery page.

Can anyone sign up to become a developer?

Anyone can apply. They would begin by signing a registered development agreement (on the portal) that lists their obligations to be HIPAA-compliant, build security into their apps, etc. Once signed up, they’ll get access to a limited amount of data, that patients have provided access to. Then they work on their app and submit it to us -- we review their app and if they pass muster, they become a data partner.

What about user datasets already being collected by Tidepool and others?

Tidepool has been a Dexcom partner since the G4 became available, and this just reaffirms that with broader access. What they are doing with their Data Donation Project is different because it’s collecting broad datasets and selling them for research purposes – whereas we’re opening up our core technology for partners to innovate on.

A core tenet of our partner agreements is Data Reciprocity, which Tidepool is in strong support of. This means they get access to patient-authorized CGM data by being our partner, and in turn we get access to any data they choose to send back to Dexcom as well.  

Does this in any way change the relationship with the Nightscout and OpenAPS communities, who’ve already been innovating based on Dexcom tech?

The message to them is that ‘we’re listening’… and we’ve evolved over time. They have motivated us to do better things, to think about doing more.

They can go to the developer portal too – we’d love to get their feedback. We’re excited about this unprecedented step to enable data to be leveraged in a variety of ways. 

But if their big push is for live data display, we can’t provide access to that now, given our current FDA constraints as a Class 3 medical device – which is our core business. Where this goes over time is going to be a function of how regulatory standards evolve.

Clearly this is a huge step on Dexcom’s part, but is it a ‘first’?

We believe we are the first public U.S.-based medical device company to launch a public API – so not just in diabetes, but a broader medtech first. We can’t 100% verify that, but we’re excited to be a trailblazer. 

We’re not only expanding patient choice and empowerment, but inviting programmers in with our developer portal, offering documentation and access to information on how to innovate on CGM data.

Remind us again -- what does this all mean for an average patient, who’s not an app developer?

It’s now all up to patients where they want to take their data, to get what they need in life to better manage diabetes. Dexcom is working to empower PWDs to choose what solutions best matches their lifestyle.

Some examples of what is possible now utilizing Dexcom CGM data include:

  • Clinicians can now view their diabetes patients’ glucose data on their smartphones, as part of their mobile practice patient care and billing workflows.
  • Patients are able to receive automated, personalized insights gained from combining data from their diabetes devices, medical records, and other apps and wearables.
  • Dexcom users can explore how their food choices impact their glucose control and connect with and learn from coaches and diabetes peers in a data-driven community.

OK, but is Dexcom not worried about a Customer Service crush if users of all these CGM-data-based apps start calling for troubleshooting help?

Well, that could happen in the beginning -- like when we moved to iPhone integration with the G4, we could never have anticipated the kind of calls we would get.  

But we don’t believe we’ll be overwhelmed with Customer Service needs – not like the blip we had in the past – mainly because these apps will not suddenly be used by our entire patient base all at once.

We do have a team of diabetes care specialists on board; they’ll have to make clear quickly that the support on nutrition advice or other functions lies with the app makers themselves. We will all have time to get established.

 

“Becoming a Consumer Company”

“We’re excited at everything this unlocks. We’re quickly becoming a consumer product rather than what we were 5 years ago,” CEO Sayer says.

CGM is not quite a mainstream product just yet – but getting there fast, if you consider the recent announcements that Dexcom data is connecting to the Apple Watch, and will be integrated with the new Fitbit Ionic smartwatch.

“There’s also Apple’s announcement about developing a next-gen watch with a cellular chip built in – imagine kids with diabetes being able to just wear a watch to school with no need for a receiver of any kind, and still being able to share their data in real-time,” Sayer says.

We pressed for details about Dexcom’s work with Google Verily developing a tiny, consumer-friendly CGM sensor, but Sayer would only say “the relationship is very good.”

In the meantime, he and Jimenez will be busy explaining the implications of this Open API and developer platform – “what it means for glycemic control and what that means for research capabilities.”

“This intersection of technology with medical/healthcare data is coming to reality in diabetes more than anywhere else – our field is leading the way.”  

No doubt to that, and we are thrilled to be along for the ride, witnessing the industry’s full embrace of the #WeAreNotWaiting mantra calling for open innovation!

 

*** UPDATE: With the launch of the new Dexcom G6 in June 2018, the company updated its Developer Portal and announced its Dexcom API Version 2 is now available. Take note, #WeAreNotWaiting friends!