Tidepool Loop Is FDA Cleared as an Automated Insulin Dosing App for Type 1 Diabetes

Tidepool Loop Is FDA Cleared as an Automated Insulin Dosing App for Type 1 Diabetes

Image of Tidepool Loop interface on iPhone and Apple Watch. Photo courtesy of Tidepool.

Around 1.45 million Americans are living with type 1 diabetes (T1D). The US Food and Drug Administration (FDA) has recently cleared for marketing an app called Tidepool Loop which can be used with compatible devices for automated insulin dosing (AID). This mobile app is intended to help manage T1D in individuals who are at least six years of age.

Tidepool Loop is the first iPhone-controlled interoperable automated glycemic controller intended for the management of T1D.

Tidepool has not yet announced a launch date for their Tidepool Loop app.

“We knew this day would come, but we couldn’t have achieved it without the support of the entire diabetes community, including the FDA,” said Howard Look, CEO, and co-founder of Tidepool, in the company’s press release. “I’d also like to personally acknowledge and celebrate the contributions of the DIY [do-it-yourself] community and participants in the Loop Observational Study conducted by the JAEB Center for Health Research, who made this milestone possible.”

People affected by diabetes, their caregivers and healthcare providers are the pillars of the non-profit organization Tidepool. They aim to ease the difficulties that patients with diabetes face in their daily routines.

RELATED: Dexcom G7 Continuous Glucose Monitor Cleared by FDA for All Types of Diabetes

How Does Tidepool Loop Work?

The Tidepool Loop app involves three integral parts: an integrated continuous glucose monitor (iCGM), a controller and an insulin pump. Data from iCGM readings and predicted glucose values are monitored and sent to the controller, which can efficiently activate the insulin pump to automatically increase, decrease or suspend insulin delivery.

With the user’s confirmation, Tidepool Loop can control the delivery of correction insulin amounts when glucose values are anticipated to exceed user configurable thresholds.

In addition, Tidepool Loop can serve as a predicate device for future interoperable AID submissions to the FDA. The innovation was supported by grants from the JDRF, The Helmsley Charitable Trust, the Tullman Foundation and individual funders.

“Tidepool Loop’s groundbreaking FDA clearance represents a pivotal step towards a world where people with T1D can choose the pump, CGM and algorithm that are best for them — and have all three work together,” said Aaron Kowalski, CEO of JDRF, in Tidepool’s press release.

“It’s also a testament to the innovation, commitment and spirit of the T1D community. We look forward to continuing to work with Tidepool to make open protocol a reality, and we anxiously await news on future AID systems that will utilize this tremendous platform,” added Kowalski.

Tidepool is currently finalizing agreements with device partners to make an easier experience for both patients using Tidepool Loop and physicians prescribing it. Tidepool did not announce its initial launch device partners, but it has a development partnership with Dexcom and other medical device companies who are yet to be named.

Tidepool is also committed to delivering Tidepool Loop to Android users, but has not given an estimate on when that work will be finished.