Tandem Mobi Becomes World’s Smallest Insulin Pump with FDA Clearance

The US Food and Drug Administration (FDA) has granted clearance to Tandem Diabetes Care, Inc.’s Tandem Mobi insulin pump for individuals six years of age and older with diabetes.

Tandem has dubbed The Mobi to be the world’s smallest insulin pump.

With a durable automated insulin delivery system, the Tandem Mobi can be completely controlled through a mobile app but also features an on-pump button as an alternative option to bolus insulin doses.

San Diego-based Tandem Diabetes introduced its t:slim pump around ten years ago and since then, the Mobi is “the first novel form factor launched in our space,” said Tandem CEO John Sheridan in a press release.

How small is the device? The Tandem Mobi is small enough to fit into the coin pocket of a pair of jeans and is less than half the size of the t:slim X2 pump. It can also be clipped to clothing or worn on the body using an adhesive sleeve that is sold separately.

The Tandem Mobi is designed for use as part of an automated insulin delivery (AID) system.

The Mobi can also automatically deliver correction insulin bolus doses (short-acting insulin taken at meals) if there is a risk that glucose levels may be falling too low. Users can also self-administer bolus insulin doses manually.

The World Health Organization (WHO) estimates that nearly nine percent of the world’s population has diabetes. In the US, 11.3 percent of the population has diabetes and of this, 23 percent are undiagnosed, according to the Centers for Disease Control and Prevention (CDC).

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The Mobi also features Control-IQ technology, which delivers insulin to users every five minutes to prevent glucose fluctuations by using compatible continuous glucose monitoring (CGM) sensor values to predict levels 30 minutes in advance.

While Control-IQ is only authorized for individuals with type 1 diabetes, Tandem presented results of a study last year that showed it could be useful for regulating blood sugar among type 2 diabetics as well.

The Tandem Mobi is expected to have its market launch towards the end of 2023 with full commercial availability planned for early 2024.

“Testing the limits of pump miniaturization, Tandem Mobi joins the t:slim X2 pump in our family of insulin delivery solutions bringing new options in wearability, the flexibility to disconnect and full phone control,” said Sheridan.

The pump’s cartridge holds 200 units of insulin and also features detachable infusion sets, which connect an insulin pump to a user’s body.

A detachable device allows users to disconnect from the pump temporarily for convenience and provides the flexibility of more than 30 mix-and-match infusion site and tubing length combinations, according to Tandem. This includes a five-inch tubing system designed specifically for the Tandem Mobi pump.

According to a GlobalData report, the North American insulin delivery market was valued at $5 billion in 2015 and is expected to reach nearly $8.5 billion in 2025.