We last updated you in February about the internal development work on Tidepool Loop, our automated insulin dosing project based on a do-it-yourself community innovation. We explained how both our industry and nonprofit partners have been incredibly supportive in our efforts to:
We described the work we were doing from a safety perspective, but also from a scalability standpoint. It’s our vision that the DIY Loop experience can be brought to a larger audience — with in-warranty best-in-class device components and with rigorous commitment to quality. We have announced partnerships with Dexcom, Insulet, and Medtronic in support of Tidepool Loop, and we have other development partnerships we hope to announce in the months to follow.
Since February, a lot has changed in our world, just as it has changed in yours. Though Tidepool already enjoyed a flexible, remotely distributed work culture pre-pandemic, our team members found themselves writing code, conducting tests, answering support tickets, and developing commercial strategy while also juggling work-from-home life with partners and children in our workspaces each day. But a world in turmoil has only strengthened our commitment to ship Tidepool Loop and be there for our community. As we all safely sheltered-in-place, we stood up a telemedicine hub (in the span of nine days) as we found thousands of people turning to Tidepool to upload diabetes device data from home.
A global health crisis notwithstanding, these last seven months have seen remarkable progress on Tidepool Loop, specifically in the realm of usability testing, or as it’s more commonly called in medical device, human factors testing. Let’s walk through some of what we’ve accomplished.
If you’re part of our community of testers, you may have been contacted by us in June through August to remotely meet with our team to explore the Tidepool Loop interface and give us feedback on our design proposals. The feedback you gave us was really valuable! We took what we learned from you to help us make the final decisions on particular workflows, like bolus delivery.
As you may know, we choose to maintain a close, collaborative relationship with FDA. Before beginning our human factors validation study, it’s standard practice to present your risk analysis data to the agency alongside your plan for a validation study protocol. In other words, you show FDA that you’ve tried to do the work to uncover all of the ways that a product might be confusing or dangerous to all the ways you’ve tried to account for it in advance, and how you plan to assess the usability of the device with representative users.
Tidepool celebrated our final Q-sub meeting with FDA in August 2020. It was a significant last communication milestone with FDA before our upcoming 510(k) submission.
At the end of August, the Tidepool team met virtually with FDA to hear their feedback on our study protocol, and for Tidepool to propose any changes to our proposed plan that might address their feedback. FDA sought to better understand if we would be recruiting a wide variety of individuals with insulin-requiring diabetes (we are), and how we would be able to adequately conduct human factors testing in a remote environment. If there’s one thing Tidepool understands, it’s how to be effective in a remotely connected world.
We believe our testing plan will have adequately addressed their concerns, and we look forward to conducting our human factors validation study. Having heard their feedback and accepted their recommendations, we marked it as the last time we’d be interfacing with the FDA team until our 510(k) submission is filed!
What follows now is to take the final version of Tidepool Loop that we intend to submit to the FDA through a rigorous study of usability with participants of different ages, genders, device experience, and length of time since diagnosis. We’re working alongside Core Human Factors, Inc., conducting three study arms to collect data from 45 or more individuals over the course of the next four weeks.
We are currently recruiting:
If you’re interested in becoming part of Tidepool’s community of testers, for this or other future studies, please fill out this screener! There is still time to enroll in this human factors study.
“We are down to the short strokes in submitting Tidepool Loop to FDA.”
— Howard Look, CEO
Our team works day in and day out to finish the regulatory documentation on the JAEB observational study data, the algorithm and insulin dosing features, product functional requirements, training materials, and risk analysis data that will accompany our 510(k) submission. We’re dividing and conquering and doubling-up on teams to see all of the work done, with all hands on deck to get the 510(k) submission out the door.
Meanwhile, many on our team will already be focused beyond the submission horizon, working toward what launch could look like. Our development team will be spending the next few months turning prototype builds of features that support launch, such as onboarding and support, into functional parts of the application, while our backend team continues to scale capacity to support more users, our frontend team builds out Tidepool Web to support Tidepool Loop integration, and our QA team tests each piece of the puzzle to ensure everything works as it should.
What can you do as a member of our community to see us cross the finish line? We’d like to humbly ask you to please consider a gift of support to Tidepool. We are the only 501(c)(3) nonprofit organization in diabetes with a commitment to bringing you continuous innovation.
We remain incredibly grateful to JDRF and to the Helmsley Charitable Trust for their ongoing support, belief, and partnership in bringing Tidepool Loop to reality, but as these organizations necessarily shift much-needed resources to support the burden of COVID-19 in our diabetes community, Tidepool must ask you to help us on these next steps.
We believe that our nonprofit status gives us the courage to do what we’re doing, but the truth is that we could not do this work we do for our community without your support. Our Human Factors work is a significant milestone for us. Can you help us reach the next mile marker?
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