This blog post is a little premature. Normally at Tidepool, we prefer not to talk about something like this until it’s closer to being ready; we’re not fans of oversetting expectations and never want to contribute to “Cure in five years!” syndrome. But since we are actively expanding the Tidepool team, including some well-known folks from the DIY diabetes community, and we want to hire even more, we think it’s better to talk openly about this now.
Here are the headlines:
- Tidepool has kicked off a project to officially support Loop, the currently do-it-yourself (DIY), open source automated insulin delivery app for iPhone. Our goal is to deliver an officially supported, FDA-regulated product, broadly available via the iOS App Store. For the sake of clarity, we will call this effort “Tidepool Loop” until we announce an official name.
- We’re working closely with grant-making organizations and commercial device makers who we expect will help with funding this effort. While the details of these funding programs are being worked out, we will keep their identities confidential (which isn’t easy for us — we like being open). To make this project happen, we will definitely need the generous support from donors, grant-making organizations and device makers. If you believe in this effort, we gratefully accept donations on our website.
- We expect the Tidepool Loop app to be compatible with at least one, and hopefully many more commercial, in-warranty insulin pumps. We are working closely with pump vendors on their “iPump” capabilities, analogous to the “iCGM” de novo designation released by the FDA in March 2018.
- Several members of the DIY community, including Loop project lead Pete Schwamb and online documentation and support hero Katie DiSimone have joined Tidepool full-time to help with this effort.
- Safety, efficacy, and quality are paramount for this program. We fully understand that people will be entrusting us with their (or their children’s) lives, and we will ensure our software operates safely and securely.
- We are partnering with the Jaeb Center for Health Research to conduct an observational study to show Loop safety and efficacy (more details on how current Loopers can participate will follow in the near future). This study has been generously funded by the Helmsley Charitable Trust.
- As a pilot participant in the FDA Digital Health Software Precertification Pilot Program, Tidepool and the FDA are working closely together to use this project as a test case for the program, benefitting future companies and projects as we go.
- As always, all code, designs and intellectual property that Tidepool produces will be released in the open.
This is a pretty big deal, so let’s dive right in:
As one of the earliest participants in the #WeAreNotWaiting movement, Tidepool and our employees have always been huge supporters of, and in some cases contributors to, projects like Nightscout, OpenAPS, and Loop. Nine of Tidepool’s current employees are personally using or have family members using Loop or OpenAPS.
There is no doubt in our minds that Loop and OpenAPS have transformed the conversation about what is possible when it comes to safe and effective care that also reduces the burden managing type 1 diabetes.
As much as we are fans of — and participants in — the DIY community, we also realize that there are several challenges that prevent widespread adoption of these incredible projects:
- 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.
Tidepool has kicked off a project to build and support an FDA-regulated version of Loop, to be available in the iOS App Store, intended to work with commercially available insulin pumps and CGMs.
What is Loop?
Loop is an automated insulin delivery app for iPhone that connects to an insulin pump and CGM using Bluetooth LE. It runs an algorithm every five minutes to adjust your basal rate for the next 30 minutes, helping you reduce or avoid high and low blood glucose. This functionality is also often called a hybrid closed loop or artificial pancreas.
Loop provides an interface to bolus from your iPhone, including for carb entries and blood glucose corrections. You can set the blood glucose targets in Loop so they best reflect your needs. Loop also provides you options to temporarily change the target for exercise or before a meal.
Loop comes with a companion Apple Watch app so you can enter carbs, bolus, and even set a temporary workout or pre-meal glucose target from your Watch. So if you have an Apple Watch, your pump and phone can stay in your pocket (or wherever you keep them).
We estimate that 1,000-1,500 people are using Loop as a do-it-yourself project today. You can read more about the open source, do-it-yourself Loop project here.
Supporting the JDRF Open Protocol Initiative and diabetes device interoperability with iCGM, iPump and iController
In August, 2017, JDRF launched the Open Protocol Initiative. The goal of this program is to help device companies over the regulatory, liability and technical hurdles of delivering products that can be interoperable, including pumps, CGMs, and controllers/algorithms.
Full, proud disclosure: We helped JDRF draft the Open Protocol Initiative, and we (Howard and Brandon, and Pete) were reviewers for some of the applications.
In March, 2018, the FDA announced a de novo iCGM (integrated CGM) designation. A de novo designation is the FDA process for creating new device classifications, in this case moving qualifying CGMs from Class-III, the highest FDA risk classification, to Class-II with Special Controls. The first CGM to get this designation is the Dexcom G6.
This was a very big deal, indicating the agency’s willingness to walk the walk in reducing regulatory hurdles for interoperable devices. In fact, with the introduction of the t:slim X2 with Basal-IQ, Tandem will be able to update the system beyond Dexcom G6 without making an additional FDA filing.
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.
We believe the Tidepool Loop project will lay the groundwork for all of this.
Open and transparent
Tidepool has always been, and always will be, a completely transparent organization. We’ve always felt that full transparency has the greatest positive impact on the diabetes community and industry. With Tidepool Loop, we will share everything we do openly, including all of interactions with the FDA, our quality system, our source code and our project plans. We hope that this will help other companies and projects going forward.
Redefining the software regulatory process with FDA PreCert
Historically, one of the things that slowed down traditional regulated product innovation is the regulatory process. Some of this was imposed by the FDA, and some of it was self-imposed by companies with overly burdensome processes and an aversion to trying new, more agile and iterative processes.
Tidepool is very proud of how we build software using modern, agile techniques and systems. We are also proud of how we’ve built our quality management system, and with our participation in the FDA Precertification Pilot Program, we can use Tidepool Loop as a pressure test for new regulatory evaluation processes that are being developed.
Let’s be super clear: The goal of the FDA Pre-Cert program is to come up with a better way to evaluate companies that are building regulated medical products. The program is still early and in development. Along with the other Pilot participants, we are helping to design and test the program. But the goal of the mission and goal of FDA has not changed: this program will (and must) ensure public health and safety.
With Tidepool Loop, we will continue to work closely with the FDA to help define the Pre-Cert Program in a way that benefits the entire diabetes community and broader healthcare industry.
How this all gets paid for
None of this will happen for free. While the existence of (the current DIY) Loop as an open source project has given us an incredible head start, Tidepool will be taking on official responsibility for maintaining, supporting, and continuing to develop Tidepool Loop, including receiving and reporting on adverse events, medical device reports, and complaints, as required by FDA regulations.
Initially, we expect these efforts will be generously supported by both public and private grant-making institutions, and well as by the generous support of donors to Tidepool. If you think this is a good idea too and have the ability to support our efforts with a donation, we’d be eternally grateful.
In addition, we will be entering into commercial agreements with the device makers whose devices will be supported by Tidepool Loop. While we can’t disclose the details of these agreements, these companies are planning to offer Tidepool’s Loop to their users, providing more choice in how their user community can manage their diabetes. As such, these companies are willing to compensate us for the work we do.
Over time, we believe that together with the community of Loopers, we will be able to show that using Loop is not only safer and more effective than traditional open loop therapy, but that it also improves quality of life by reducing much of the burden of managing diabetes. We believe that demonstrably improving quality of life will be impactful to health insurance payers.
We don’t usually like talking about things before they are nearly ready to ship. In this case we feel that there is great value to the community and industry in transparently sharing everything we do along the way. As we have more to share, you can follow along on our blog, and our Twitter and Facebook feeds.
Tidepool Loop is a project built upon on the shoulders of the do-it-yourself giants in the #WeAreNotWaiting community who laid the foundation for this incredible opportunity. I encourage you to read the original vision and history of Loop, written by Nate Racklyeft, the founding developer.
We are humbled by the countless contributions of the diabetes community to make this all possible, and welcome the exciting journey ahead to bring more choice to people with diabetes. To all of you who got us this far, thank you!
Still have questions?
Does this mean that the DIY version of Loop will no longer be available?
Open source projects often continue life of their own outside of officially supported versions. Tidepool will not support or maintain these projects, but others in the community may.
The Tidepool version of Loop in the App Store will be the only version that Tidepool supports and takes responsibility for. We hope that for a lot of people, the existence of an officially supported version of Loop will be an awesome alternative to the DIY version. But we also believe that some folks may wish to continue using their own DIY versions. (For what it’s worth, many of us at Tidepool use Loop, OpenAPS, Nightscout and many other DIY projects.)
Will Tidepool accept community contributions to the Tidepool Loop code?
Absolutely. While Tidepool will ultimately be responsible for code, we will definitely consider all community contributions, and will also make our code openly available.
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.
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.
Are Pete Schwamb and Katie DiSimone really joining Tidepool?
Yes, we’re super excited. As the creator of RileyLink and lead maintainer of the DIY Loop, Pete has had an incredible impact on the community. And Katie’s stellar work on LoopDocs.org show her dedication to the community. We’re thrilled to have them both join the Tidepool team.
Does that mean that Pete and Katie will no longer be contributing to DIY efforts?
No, it does not. Many Tidepool employees contribute to open source and DIY efforts outside of their Tidepool responsibilities.
What sort of conversations have you had with the FDA about Tidepool Loop?
From Tidepool’s beginning, we believe in engaging early and often with the FDA. Our commitment to openness and transparency means we will share our meeting minutes with the FDA with the Tidepool community on tidepool.org/documents as they are approved.
I’m a software developer, customer support person, quality assurance engineer, designer, program manager… and I love Loop… Can I work at Tidepool?
We’d love to hear from you! We are indeed hiring and growing the team. Please check out tidepool.org/jobs and get in touch.
What about Tidepool Web/Uploader/Mobile?
Tidepool’s mission is to make diabetes data more accessible, meaningful, and actionable. Tidepool Loop fits into the “actionable” part nicely, but there’s still plenty of work for us to improve and iterate upon the rest of our software. That work will not stop, if anything, we expect it to pick up as we add more people to the Tidepool team (PS. Did we mention we’re hiring? Check out our jobs page for more information!)
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, when, when?
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. We promise we will keep you updated as things progress.