Tidepool Expands Closed Loop Access, Wins Clearance From FDA

The FDA cleared Tidepool Loop for people with type 1 diabetes ages six and up. Tidepool Loop is now the first “do-it-yourself” automated insulin delivery system on the market with clearance from the FDA.

The FDA cleared Tidepool Loop on Jan. 24, making it the first FDA-cleared “do-it-yourself,” or DIY automated insulin delivery (AID) system, on the market.

The software, developed by nonprofit Tidepool, connects three components: a continuous glucose monitor (CGM), an insulin pump, and the Tidepool Loop algorithm, which will be available on the app store on iOS or Apple smartphones.

 

Tidepool Loop Features

Tidepool Loop has several features that differ from other available AID systems.

First, the app has a “pre-meal preset” mode, which allows users to customize their desired glucose range around a meal, reducing the risk of low blood sugar that comes from insulin bolusing before meals.

The system enables users to proactively, or retroactively adjust the amount of insulin after a meal by entering the estimated amount of carbs into the app. This extended bolus feature allows for quick adjustments to the potentially unpredictable glucose changes that come from living with diabetes.

Tidepool uses different food emojis to indicate different amounts of carbohydrates. For instance, the user can tap a lollipop emoji for a small amount of fast-acting carbs for a 30-minute bolus of insulin, a taco for snacks and most meals for a 3-hour bolus, or a pizza for a larger meal with a longer extended 5-hour bolus.

Tidepool is also the first AID app that can be controlled directly from an Apple Watch, giving users more discretion and convenience when dosing insulin. The app will not be available on Android devices at launch; however, according to the Tidepool website, the company is working to expand compatibility to Android devices.

Perhaps the most significant feature of Tidepool Loop is the software’s ability to allow components from different insulin delivery systems to communicate in a coordinated way, without effort needed from the user. The Tidepool Loop system itself does not come with a CGM and insulin pump – it is its own AID algorithm that can operate a CGM and insulin pump through the mobile app. In other words, the CGM gets the necessary information, Tidepool Loop is the brains, and the pump administers insulin.

Tidepool has not yet announced which devices will be compatible with the system, but the company has existing partnerships with CGM manufacturer Dexcom and pump makers Medtronic and Insulet. Tidepool has said that it intends to support a future version of Insulet’s Omnipod insulin pump, a future Bluetooth-enabled MiniMed insulin pump from Medtronic, Dexcom’s CGM, and Medtronic’s Guardian Connect CGM with Tidepool Loop.

Unlike existing AID systems that work exclusively with one brand, Tidepool Loop’s interoperability may give users more flexibility to choose the compatible pump and CGM they prefer.

Access to DIY Looping

Although Tidepool Loop is the first DIY algorithm to be cleared by the FDA, a small number of people in the type 1 diabetes community already use DIY looping software. Past studies have indicated that people who use DIY looping experience improvements in time in range and overall quality of life.

Previously, DIY looping could only be accomplished if users were willing to “hack,” or jailbreak, their insulin pumps and install new software. In addition to requiring technical expertise, users assumed all responsibility for a pump malfunction – a risk that many chose to avoid. An FDA-cleared system like Tidepool may address these limitations and allow many more people with type 1 diabetes to access the benefits of this type of AID system.

Tidepool Loop Launch Timeline

Tidepool has not announced an expected timeline for the launch of the new AID system. The company is currently working to finalize partnerships with CGM and pump manufacturers to confirm compatibility with Tidepool Loop, as well as an official launch date. Once the system is launched, healthcare providers will be able to prescribe the system to their patients, who will then be able to set up the mobile app they obtain from the Apple App Store and connect a compatible insulin pump and CGM. Tidepool has not yet released pricing information about the system.

diaTribe will continue to follow this story as more information becomes available. Those who are interested can sign up to receive more updates directly from Tidepool.