FDA Clears Tandem’s Mobi Insulin Pump

Tandem’s new Mobi automated insulin delivery system has received FDA clearance, making it the world’s smallest insulin delivery system to be fully controlled by a smartphone.

Tandem announced that its forthcoming automated insulin delivery (AID) system, the Tandem Mobi, has been cleared by the FDA for people ages 6 and up with diabetes, making it the smallest durable insulin delivery system available in the U.S. that can be fully controlled by a mobile app.

The Mobi is less than half the size of the t:slim X2, Tandem’s current hybrid closed-loop system, and includes a 5-inch tubing option. Unlike the t:slim X2, it will not include a screen but instead, be fully controlled by an iPhone app. The Mobi has an on-pump button, providing another quick option for people to bolus insulin if they don’t want to do it from their phone.

The insulin pump holds a 200-unit insulin cartridge yet is small enough to fit in a coin pocket. It can also be clipped to clothing or worn with an armband or adhesive sleeve, giving users a wider range of less conspicuous wearability options. The pump is also water resistant, supports wireless charging, and can receive remote software updates.

FDA clearance of the Mobi positions Tandem to compete even more directly with Insulet’s Omnipod 5. Right now the Omnipod 5 AID system is controllable using either a remote Insulet controller or an Android app. Insulet has submitted its Omnipod 5 app for iPhone; the app is currently pending FDA clearance.

In addition to a continuous glucose monitor (CGM), infusion set, and insulin pump, some of the Mobi’s main features include:

Mobile app: Compatible with an iPhone, the Tandem Mobi can automatically administer insulin via a mobile app. This enables users full control from a smartphone, with the option to manually bolus if needed.

Control-IQ technology: This algorithm interprets CGM data to predict blood sugar levels. Designed to be used with an AID system, Control-IQ adjusts insulin delivery every five minutes in order to prevent highs and lows and spend more time in range.

Shorter tubing option: In addition to more than 30 existing infusion sites and tubing length options to choose from, users of the new Mobi will also have a shorter 5-inch tubing option.

Tandem anticipates a limited release of the product in fall 2023, with hopes for full FDA approval planned for 2024. Potential Mobi users can subscribe to get updates on the Mobi system’s availability on Tandem’s website.

Photo credit: Tandem Diabetes Care

Learn more about automated insulin delivery here:

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The Need for Automated Insulin Delivery Systems During Pregnancy in Women with Type 1 Diabetes