Reflecting on Loop and Tidepool’s visionary impact on diabetes innovation

I’ve spent the past week reflecting on something that once felt audacious: Sequel Med Tech has officially launched the twiist AID System Powered by Tidepool. As Howard has always reminded us, to get to this milestone the Tidepool team stood on the shoulders of giants, bringing a community-led solution through the FDA’s regulatory process, and paved the way for Sequel Med Tech to bring it into the hands of people living with diabetes. 

This moment has been years in the making — from the early conversations during team onsites about truly interoperable automated insulin delivery, to the vision set by Howard Look and Brandon Arbiter in 2018, to countless meetings with the FDA.

That FDA clearance was hard-earned: hundreds of code reviews, thousands of tests, simulations, risk assessments, and, critically, the contributions of everyone who participated in the Loop Observational Study conducted by the JAEB Center for Health Research. Real-world evidence supported our FDA submission, becoming a cornerstone of the clearance Tidepool Loop received as a Class II Medical Device. You can read more at tidepool.org/documents.

But FDA clearance was just the beginning. It’s only meaningful if it reaches real people. Thanks to the dedication of the teams at DEKA and Sequel, the twiist pump came to market faster than many expected — though in truth, this was always the shared vision between Breakthrough T1D, the Helmsley Charitable Trust, the FDA, and all of us at Tidepool: companies focusing on what they do best, partnering to expand choice for the diabetes community.

The industry, as a whole, has taken a tremendous step forward over the years, embracing the regulatory pathways set forth by the FDA in the name of interoperability and patient choice. But the #wearenotwaiting movement was born out of a desire for more, and Howard and Brandon knew we were in a unique position to make Loop accessible for as many people with diabetes as possible.

We now live in a world where Sequel Med Tech has brought a brand-new insulin pump to market, based upon the Tidepool Loop algorithm. A world where people with diabetes have more choices in how they manage their care. Where emojis replace the math of extended boluses, an Apple Watch can manage your diabetes discreetly, and people can set glucose targets as low as 87 mg/dL.

That reality didn’t fully sink in until last week, standing alongside my colleagues at the Children with Diabetes Friends for Life Conference in Orlando. For years, I’ve talked about what Tidepool Loop could do. Now, I get to talk about what Tidepool Loop does. Present tense.

We’re here. And we’re just getting started. Our focus now shifts to the future of Loop: new features, shaped by our User Research Community, improving outcomes, extending partnerships. Thanks to leaders like Aaron Kowalski (Breakthrough T1D), David Panzirer (Helmsley Charitable Trust), and countless donors and supporters, we achieved FDA clearance for Tidepool Loop - and now, in partnership with Sequel, a Tidepool Loop based algorithm is available to people living with diabetes in twiist. 

We are beyond proud to put the “Tidepool” in twiist AID System Powered by Tidepool.

If you believe in what we’ve built and where we’re headed, I’d love to invite you to be part of it. Your support at tidepool.org/donate helps us continue this work: making sure the next audacious idea becomes real for more people living with diabetes.