Tidepool Loop development update

It’s been a little over a year since we publicly announced our intention to develop Tidepool Loop, a fully supported and FDA-cleared iPhone app that brings together an insulin pump, CGM, and automated insulin dosing algorithm that adjusts your basal rates as often as every five minutes and allows you to bolus from your phone. Thanks to support from JDRF and the Helmsley Charitable Trust, we've been able to grow our team significantly and make tremendous progress on this ambitious goal.

This post will cover everything about Tidepool Loop that we can cover, and there’s a lot.

To answer the biggest question upfront: we do not have a release date for Tidepool Loop to share at this time.

When we do, we’ll share it — via email, social media, smoke signals, semaphore, carrier pigeon, Morse code, interpretive dance, and any other method of communication we can get our hands on. We’re actively working on our FDA submission and as soon as we have more to share, you’ll be hearing from us. Promise.

We believe closed loop therapy should be the standard of care for people with diabetes who require insulin, and our whole team is working to make that happen.

FDA paving the way

Before we get into what we’ve done over the past year, let’s take a moment to make sure everyone is on the same page.

In the last few years, the FDA has laid out a vision for interoperable automated insulin dosing systems, where a CGM, insulin pump, and software controller work together to help manage blood glucose. Diabetes device makers, including our partners Dexcom, Insulet, and Medtronic are rising to the challenge, developing the interoperable CGM and insulin pump components of this system.

Recently, the FDA created an approval pathway for the third piece of this automated insulin dosing puzzle — the interoperable automated glycemic controller (iAGC). We now have a clear roadmap defining the expected steps for clearing a controller with the FDA and for the agency to be able to evaluate safety of a glucose control algorithm.

Tidepool Loop is designed to work with diabetes devices that have been cleared by FDA as interoperable — officially termed as “integrated CGMs” (iCGM) and “alternate controller enabled” (ACE) pumps. So far, FDA has granted these designations to one CGM (Dexcom G6) and two insulin pumps: Tandem’s t:slim X2 and Insulet’s Omnipod DASH. We look forward to seeing more devices receiving these designations in the future.

Setting the stage for Tidepool Loop

At Tidepool, we committed to fulfilling that vision by producing the final piece of the puzzle — an interoperable software controller. To do so, we’re building Tidepool Loop by taking the publicly available, open source do-it-yourself (DIY) Loop code base and putting it through our software engineering process and quality management system. At the end of those processes, our plan is to submit Tidepool Loop to the FDA for clearance.

As an automated insulin dosing app for iPhone, Tidepool Loop is being designed to connect to an insulin pump and CGM using Bluetooth LE wireless communication. The goal of Tidepool Loop is for you to have an app that takes a look at your insulin, glucose, and entered carbs and adjusts basal rates as often as every five minutes in an attempt to reduce or avoid high and low blood glucose. Since the DIY Loop code base has given us a tremendous head start already being written for iPhone, we are focused on iOS first, with Android support planned for future development.

Tidepool Loop is intended to be available by a prescription from your healthcare provider and downloaded via the App Store. When updates to Tidepool Loop are available, you’ll update it like any other app you download from the App Store. Tidepool Loop will be FDA regulated, and fully supported by Tidepool; when you have a problem with Tidepool Loop, we’ll be ready to help.

Our goal is to offer people with diabetes choice and interoperability — supporting multiple in-warranty pumps and CGMs, which fits in perfectly with our mission to make diabetes data more accessible, meaningful, and actionable. We help you access your data with Tidepool Uploader and Tidepool Mobile. Tidepool Web makes your data meaningful. And Tidepool Loop is how we plan to make your data actionable.

As we shared with you back in June, we’ve announced development partnerships with Insulet, Dexcom, and Medtronic. Our intent is to support a future version of Insulet’s Omnipod® insulin management system, a future Bluetooth-enabled MiniMed™ insulin pump system from Medtronic, Dexcom’s current Dexcom G6 continuous glucose monitoring system, and Medtronic’s Guardian Connect CGM system with Tidepool Loop.

It’s genuinely exciting to see all of these pieces come together.

Working with Insulet and Dexcom

In order to integrate with the devices that will be part of Tidepool Loop, we have to be able to test, and test, and test. Rather than use and throw away pods and CGM sensors, our partners have supported us with everything our software and QA engineers need to efficiently run those tests.

In addition, we also have a large (and ever growing suite) of both manual and automated tests to verify that the functionality of Tidepool Loop is working as intended.

So where are we in terms of device integration and testing of Tidepool Loop?

• The Tidepool Loop app intends to include the core functionality of our partners' respective device interfaces replacing the need for the user to run a separate app.
• We have test builds of Tidepool Loop that are accessible to our Quality Assurance (QA) team through Apple’s App Test platform, TestFlight, making delivery of updated development builds easy to distribute and download as needed.
• Throughout our development process, we’re in regular communication with our partners at Insulet and Dexcom to share progress and provide feedback to their respective engineering teams.For example, when Apple releases a new version of their iOS operating system, we may need updated resources from our partners to make sure Tidepool Loop stays current. Working through these processes now during initial development will help us tremendously once Tidepool Loop is widely available.

On the path to commercially supported

Here’s a small sample of the kinds of tasks our engineering, design, and QA teams are tackling.

More specifically, here are some key efforts on our to-do list:

Safety first

• We're currently working on design updates to improve the usability and accessibility of the Tidepool Loop app.
• We’ve gone line by line through the FDA’s special controls for an interoperable automated glycemic controller (iAGC) and are following that roadmap to prepare our FDA submission for Tidepool Loop through the 510(k) process. (We’ll share more about the regulatory journey soon.)

Support

• We're rapidly iterating on our approach for training and support interactions, and working to validate that users will be safely onboarded to Tidepool Loop.
• We’re also working to ensure healthcare providers will have the support and training materials they need to prescribe Tidepool Loop to people with diabetes and work with them to change their settings.

Our support system will need to seamlessly integrate with Dexcom and Insulet to enable us to hand off support issues.

Market access

• We're building out our online prescription process and platform, so healthcare providers will be able to enter Tidepool Loop settings in-clinic during an appointment.
• We're working on our marketing plan for Tidepool Loop — in collaboration with our partners at Insulet and Dexcom — to set Tidepool Loop up for the best possible success at launch and in the long-term. Content is being developed for prospective users of Tidepool Loop, and prospective health care teams prescribing Tidepool Loop. Our website, tidepool.org, will also expand to accommodate the wide range of Tidepool Loop content needs including training, onboarding, and provider-specific interactions.

Post market plan

• We are also working to define a roadmap for future updates. Which updates will require FDA review? What kinds of updates will we be able to release after our verification and validation testing is complete without FDA review? How will we conduct beta tests of new features with Tidepool Loop users? We are working to document our answers to these questions, and more.
• We’re defining our process for ongoing data collection on the safety and efficacy of Tidepool Loop. As always, Tidepool plans to be radically transparent with this safety and efficacy data (all aggregate and anonymized, of course). This data will help us make sure Tidepool Loop is and remains safe and effective, and we want you to be able to see that real-world data for yourself so you can make informed decisions about your diabetes management options.

We know that’s a very brief look at where we are and where we have left to go, and we hope you want to know more and will check back in with us. What’s exciting for everyone on the Tidepool team is seeing the amount of work we’ve already completed on this effort in the last year toward releasing Tidepool Loop. We have a lot of work to do as we finalize development, but every day is a step forward. Truly, it’s inspiring to see it all come together.

We’re in this together. For our lives and the lives of those we love — we have pancreas in the game and we are committed to bringing Tidepool Loop to life.

If you’re as excited about this as we are, be sure to fill out our Tidepool Loop Interest Form so we can keep you up to date on future developments.