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Tidepool Announces Plans For New, FDA Regulated Mobile App

Tidepool, a nonprofit company focused on freeing data from diabetes devices, has announced a new project to build and support an FDA-regulated version of its app, Loop, to be available in the iOS App Store.

“Our goal is to deliver an officially supported, FDA-regulated product, broadly available via the iOS App Store,” states Tidepool’s team on their company website.

The app will be called the “Tidepool Loop” until the company comes up with an official name. The company expects the Tidepool Loop app to be compatible with at least one, and hopefully many more commercial, in-warranty insulin pumps.

The app is intended to work with commercially available insulin pumps and CGMs. In line with Tidepool’s mission, to make diabetes data more accessible, all code, designs and intellectual property that Tidepool produces with the Loop app will be released to the public.

The reasons for the shift from a purely DIY community, Tidepool explains, is that not everyone is comfortable building and maintaining their own DIY system.

Also, many people with diabetes are not comfortable using a system that isn’t FDA cleared or approved and many doctors and CDEs are not willing to recommend a product to their patients that is not FDA cleared or approved.

What’s The Existing Loop?

Tidepool’s existing 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 a person’s basal rate, helping to 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 the iPhone, including for carb entries and blood glucose corrections.

How Will The New App Differ?

Tidepool plans to officially support Loop, which is currently do-it-yourself (DIY), open source automated insulin delivery app for iPhone.

Tidepool plans to work with several device manufacturers, and is looking to establish commercial agreements with them to support the work behind Tidepool Loop.

The company is working with organizations and commercial device makers who they expect will help with funding this effort.

Tidepool expects 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,” they state.

The nonprofit will partner with the Jaeb Center for Health Research to conduct an observational study to show Loop safety and efficacy.

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