In the past few years, there's been a lot of excitement about the opportunity for people with diabetes to create their own homemade do-it-yourself artificial pancreas systems. Thousands now use these worldwide, but the downsides have held many people back: the complex build-it-yourself process; having to rely on older, non-warranty devices; safety fears; and the lack of an established tech support infrastructure beyond the open source community. 

That's all about to change, thanks to open-data nonprofit Tidepool.

On Monday morning, Tidepool announced the kickoff of a project to officially support Loop, the currently DIY open source automated insulin delivery app for iPhone. Their goal is to deliver an officially supported, FDA-regulated product, broadly available via the iOS App Store.

This is BIG, because it marks the first time a crowdsourced DIY diabetes solution will morph into an "official" FDA-approved product, that can compete with offerings from established vendors. This move essentially takes DIY tech that's been largely a "use at your own risk" proposition into the mainstream, allowing for a product that's not only FDA cleared but also one that healthcare professionals may be more comfortable prescribing and discussing with their patients. Also, users would now be able to easily use the Tidepool Loop app with any supporting insulin pump device they may want -- no more scrounging for old, used Medtronic models (the only option so far).

Don't fret: Loop as it exists now isn't going away. The DIY versions of Loop and its components like RileyLink will still exist and continue to evolve as this new Tidepool Loop option materializes.

"The vision is about creating an ecosystem, where you get to choose what's right for you as a person with diabetes," says Tidepool founder and D-Dad Howard Look. "This doesn't get us all the way there, but it's a big step in the right direction. This pushes everyone forward, to thinking about interoperability and interchangeability, and that makes for a better world for people with diabetes."

To date, Palo Alto-based Tidepool has focused on building a cloud-based platform where people can collect and combine data from different meters, insulin pumps, and CGMs to be able to review all of their diabetes data in one spot. This continues the mission, but takes it to the next level, Look says.

 

A #WeAreNotWaiting Refresher

OK, since there's quite a bit of insider-baseball talk here, let's step back for a moment and offer a refresher (primer?) on the #WeAreNotWaiting movement and the many components mentioned:

#WeAreNotWaiting: hashtag #WeAreNotWaiting is the rally cry of folks in the diabetes community who are taking matters into their own hands by developing platforms, apps and cloud-based solutions, and reverse-engineering existing products when needed in order to help people with diabetes better utilize devices and health data for improved outcomes. The idea is, "We are not sitting back and waiting for the authorities to make these things happen for us." (Note the term was actually coined at our first-ever DiabetesMine D-Data ExChange gathering at Stanford University in 2013.)

The DIY movement began most notably with Nightscout, a tool for remote data-sharing via mobile app, website and smartwatches. That was before any manufacturers launched their own products with these capabilities. Interest in mHealth digital tools has exploded over the past five years, with burgeoning closed loop functionality at the center of that in the diabetes world.

iCGM: a new regulatory designation the FDA just established in March 2018, to indicate CGMs that are highly connected with other mHealth devices. Basically, it sets up a framework for future connective CGM devices (so far only Dexcom G6) to be interoperable with other devices and data platforms, and allows them to be approved via a simpler regulatory process. The end game is making it easier for us PWDs to choose between the various devices we want to use, knowing they'll be able to "talk to each other."

RileyLink: D-Dad Pete Schwamb from Minnesota is the main guy behind this little box that's become a critical part of many DIY AP systems. It handles communication between the insulin pump (those older models) and CGM. It's basically the radio bridge between the devices -- speaking the Bluetooth LE language of the iPhone and converting it to 900Mhz frequency that the older Medtronic pumps use. That allows for communication with mobile apps, like Loop, used to control the insulin-dosing functionality via a smartphone or mobile watch.

Loop: a DIY automated insulin delivery algorithm app that operates as the "brain" of this particular homemade closed loop system, containing the algorithm and user interface to control the insulin-dosing and AP functionality. To date, this solution has been completely open-source and non-commercial. It's estimated that 1,000-1,500 people globally are using Loop as their DIY closed loop tech. Loop is the name for the app (or so-called iController or iAlgorithm), while LoopDocs refers to a site with the documentation and instructions for DIY'ers to build systems using this diabetes tech.

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OpenAPS: the DIY closed loop system developed largely by Dana Lewis and Scott Leibrand that's one of the most visible examples of this homemade technology. T1 PWD Dana started creating it in 2013 and it's evolved with community input ever since. It uses algorithms to control the insulin functionality, though unlike Loop where the algorithm is based on the phone app, OpenAPS uses a separate Edison mini-computer or related item to act as the brains of the system.

AndroidAPS: Stemming from Europe, this is a Droid-focused version of the OpenAPS mentioned above. It works largely the same way, and is mainly led by D-Dad Milos Kozak in the development community.

Tidepool Loop: name of the new, Tidepool-supported official version of Loop that will be offered on the Apple Store and regulated by FDA. It won't rely on RileyLink or the outdated insulin pumps, according to Look.

FDA Digital Health Software PreCertification Program: In 2017, the federal agency launched a pilot program designed to speed up the regulatory process for health software by creating a "trusted network" system of developers. Tidepool was one of nine companies chosen to participate, and they now part of regular meetings to determine the best protocols that can be used when making new apps or software. As part of this FDA pilot, Tidepool is working with regulators -- and their new Tidepool Loop project is viewed as a potential "test case" that can be used for future DIY technology that may be brought into the regulated commercial space.

JDRF Open Protocols Initiative: launched in late 2017, the JDRF Open Protocols Initiative aims to encourage device manufacturers to build products that are interoperability-ready. JDRF's goal was really to set a baseline for "plug-and-play" diabetes tech, again pushing for a world in which PWDs can pick and choose the particular devices they might want to use, and know that they will function well together. While Tidepool Loop isn't directly tied to this Initiative, the efforts certainly overlap and the goals go hand-in-hand.

 

Overcoming Hurdles, Cracking Open Interoperability

In its announcement, Tidepool expresses excitement about helping the D-community "overcome several challenges that prevent widespread adoption of these incredible projects." In Tidepool's words:

  • For most people, their only option is to buy an old, used Medtronic pump. We think that’s just not right. People should be able to use officially supported and commercially available pumps. We shouldn't have to buy old, unsupported, out-of-warranty pumps on Craigslist, eBay, or Medwow to get great care.
  • Not everyone is comfortable building and maintaining their own DIY system.
  • Many people with diabetes are not comfortable using a system that isn’t FDA cleared or approved. And many doctors and Certified Diabetes Educators (CDEs) are not willing to recommend a product to their patients that is not FDA cleared or approved. The FDA would really love for there to be an entity that takes responsibility for support and tracking of safety and efficacy, including “post-market surveillance” (the fancy term for "gathering and analyzing data to make sure a pharmaceutical drug or medical device is safe and effective after it ships").
"Tidepool has come to the conclusion that we are in a unique position to help address all of these hurdles. Now imagine that insulin pumps were also interchangeable based on an 'iPump' designation. This kind of interoperability gives people living with diabetes more choice and speeds products to market. We support that. But don't stop there. Now imagine that there are different apps, or algorithms within apps, that you get to choose from, and that these 'iControllers' and 'iAlgorithms' would work interoperably with multiple pumps and CGMs. We support that, too."

Tidepool Loop is envisioned to lay the groundwork for all of this. And a notable aspect is how Tidepool is already sharing the discussion points with FDA and others on this, putting documentation and meeting minutes online for the world to follow along.

In its FAQ, Tidepool also explains the following and we've added in other aspects based on our interview with Look and our own reporting here at DMine:

What is the business model for Tidepool Loop?

Tidepool is engaging with several device manufacturers, and we are actively working to establish commercial agreements with them to support the work behind Tidepool Loop. After all, we think it will be good for the community ​and​ good for their business. As soon as we are able to share that information with you, we will.

Which partners?

As of now, Tidepool hasn't released that information and the org says it hasn't finalized agreements to be able to publicly share that. But we expect that Tandem is a likely candidate, especially given the company's Basal IQ partial closed loop already works with the Dexcom G6 as an iCGM device and the pump company is planning to submit its t:slim X2 to the FDA as a first "iPump" before long. We can also gather that the existing pump companies participating in the JDRF's Open Protocols Initiative -- Roche, Sooil, SFC Fluidics, and Ypsomed -- will also be primed for this Tidepool Loop connectivity.

How much will Tidepool Loop cost?

We are engaging with payers (health insurance providers) to establish a reimbursement pathway for Tidepool Loop. This will take some time. We don't yet know what the pricing model for Tidepool Loop will be, but we are keenly aware that asking end users to pay for it out of pocket would be a bad idea. We'll keep the community updated as this proceeds.

What about Android?

We're going to start with the iPhone version first, but we fully intend to address Android users in the future.

When will it be available?

 We don't know yet. We are just getting started. The current DIY Loop codebase is an incredible start, but it would be irresponsible and premature to predict how long it will take to do everything necessary to get a regulated version of Tidepool Loop into the App Store.

Tidepool is working with the Jaeb Center for Health Research on the clinical study component of all this, with a $1.5 million grant from the Helmsley Charitable Trust, to collect data showing the safety and effectiveness of those using these DIY closed loop system with this Loop app. They expect this observational study to include 150-300 current Loopers, collecting real-world data from those using these current DIY systems, and the hope is to start it by the end of 2018. To date, details on the clinical trial are not yet public, but Tidepool plans to share more once that's finalized.

For more, see Tidepool's blog post and full FAQ on this announcement.

 

Hiring from the Diabetes DIY Community

Notably, this move includes Tidepool's hiring of two high-profile members of the grassroots #WeAreNotWaiting community:

Minnesota D-Dad Pete Schwamb, whose daughter Riley, diagnosed at age 6, was the inspiration for him creating that  little box called RileyLink, which enables the connectivity between pump-CGM-smartphone app for controlling a DIY closed loop system.

Within months of his daughter's diagnosis and her starting on a Medtronic pump, Pete found himself frustrated by his inability to get D-Data off that device to share and monitor. This was especially problematic for Pete as a long-time engineer. He started building a separate device with a radio signal to reverse-engineer his own workaround, developing into the RileyLink box, which communicates with the pump.

Thousands of these little RileyLink boxes have gone out globally, designed by Pete and made by another DIY’er who has a sister with T1D, and shipped by yet another fellow type 1 peep.

To be clear, RileyLink will continue to exist outside of Tidepool; this move toward Tidepool Loop doesn’t bring that in-house, and Pete says he’ll continue developing that along with others in the community.

But he's super-excited about the Tidepool Loop project. “This is an amazing confluence of events and people coming together," he tells us.

California D-Mom Katie DiSimone, whose 12-year-old daughter Anna was diagnosed about four years ago and has since spent countless hours providing support for folks working to build their own home DIY systems. She is the force behind LoopDocs, an amazing set of easy-to-follow documentation and instructions that includes a number of 'how-to' videos and is aimed at bridging the gap between tech-savvy DIY'ers and those without any technical expertise.

After Katie's daughter was diagnosed in 2014, they started off on injections and fingersticks, and shortly after began using a Dexcom CGM. That's when Katie found an Instagram post of someone’s Pebble watch showing off glucose data -- “What magic is that?” Katie recalls thinking -- and from there she discovered CGM in the Cloud on Facebook and became a part of that DIY community.

Though their family watched the early development of this open-source closed loop technology, her daughter loved the OmniPod tubeless pump too much and didn’t want to carry around the early iterations of the DIY systems. That changed in mid-2016 when Anna started high school and warmed up to the idea of a tubed pump. Katie discovered the closed loop tech of Loop and RileyLink and helped he daughter begin using that, and with her engineering background, Katie eventually started creating the documentation and instructions to help the community better navigate these build-it-yourself devices, in a “soccer mom, I don’t do code” kind of way. That’s all been on a volunteer basis while Katie’s maintained a full-time job, and now she’ll join Tidepool where she can devote her work hours to these projects.

“I’m really excited to see where it can go,” she says. “By Tidepool and all of us putting our efforts together like this, we can get Loop as an iAlgorithm app through the FDA process and offer an incredible platform for pump and CGM manufacturers to be a part of this community -- to meet their customers where they’re asking to be met.”

Both Pete and Katie will begin working full-time for Tidepool, but they also plan to continue their DIY projects on LoopDocs and RileyLink, or anything else in the community they're passionate about -- much like other Tidepool folk already do, in the spirit of pay-it-forward.

 

Creating Synergy Between the DIY and Medical Communities

This is very early in the process, to be clear. Tidepool notes that most companies wouldn't normally talk publicly at this point and hype up future plans, largely because that "5 years away" status always brings eye-rolls. But with the high-profile DIY hires and nature of this Tidepool Loop announcement, keeping it a secret within the #WeAreNotWaiting just isn't realistic.

They just couldn't wait, you might say :)

“It will be a significant game-changer,” Katie says about the future potential of Tidepool Loop and the pathway it creates. “A patient will be able to just walk into a doctor’s office and have that understanding like they do now with traditional diabetes devices on the market. We'll be providing training and support for endos and educators, so they’ll have a comfort level with the algorithm and how it works, to support their patients on it. The more we can get the formal medical community to understand how the DIY community has grown and how it makes a difference for T1 management, the better for everyone.”

Katie also says pump and CGM companies can benefit from this, as it creates a channel of potential customers who’d be excited to be on that particular pump if it’s connected to the Loop algorithm. 

“The natural worry for people when hearing ‘commercial product’ and ‘FDA regulation’ is that this means the project’s dead, that it won’t be around in the way we’ve come to love it, but that’s not the case for this. I wouldn’t have joined otherwise," Katie says. "It’s such a step forward, and so innovative. People have been over-promised and under-delivered for so long in this community, and this is a real beacon of promise that has tremendous momentum going forward.”

Congrats to these innovators -- Tidepool, Loop and RileyLink creators and the whole DIY part of the D-Community for a big step forward in positive synergy for all!