FDA Clears Tandem’s Mobi Insulin Pump for Ages 2+

Tandem’s new Mobi automated insulin delivery system has received FDA clearance, making it the world’s smallest insulin delivery system to be fully controllable by a smartphone for ages 2 and older.

Tandem Diabetes Care announced that its forthcoming hybrid closed-loop system, the Tandem Mobi, which had been cleared by the U.S. Food and Drug Administration (FDA) for people ages 6 and up, will now be available to children ages 2 and older with type 1 diabetes.

Both the Tandem Mobi, which comes out in 2024, and Tandem's existing insulin pump, the t:slim X2, utilize Control-IQ Technology, a prescription-only software that automates glucose levels using an algorithm that analyzes continuous glucose monitor (CGM) readings and determines how much insulin to deliver. Control-IQ, which had previously been cleared for ages 6 and above, has now been cleared by the FDA for children 2 years of age and older.

 The FDA's age expansion gives families and healthcare teams access to a useful new tool for pediatric diabetes, which can be especially hard to manage.

When it enters the market next year, the Tandem Mobi will also be the smallest durable automated insulin delivery system available in the U.S. that's fully controllable from a mobile app. It's less than half the size of the t:slim X2 insulin pump, Tandem’s current hybrid closed-loop system, and includes a 5-inch tubing option.

Unlike the t:slim X2, the Tandem Mobi will not include a screen but instead offer full iOS mobile control through an iPhone app. The Mobi has an on-pump button, providing another quick option for people to manually 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 Tandem Mobi insulin 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.

Tandem Mobi features

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 insulin if needed.

Control-IQ technology: This algorithm interprets CGM data to predict glucose 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 combinations to choose from, users of the new Tandem Mobi insulin pump will also have a shorter 5-inch tubing option.

Right now, Tandem's Control-IQ technology only works with a Dexcom CGM but the company is looking to incorporate Abbott's FreeStyle Libre.

Tandem Diabetes Care 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.

Learn more about Control-IQ and automated insulin delivery here:

Automated Insulin Delivery Improves Time in Range

Medtronic MiniMed 780G Now Available in the US, Covered by Medicare

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

Control-IQ: The Good, the Challenges, and Tips

Photo credit: Tandem Diabetes Care

Credited: [Author: Anna Brooks, Susannah Chen] Source: diaTribe Learn MAKING SENSE OF DIABETES