Tandem's Mobi miniature insulin pump secures FDA clearance

Tandem Diabetes Care announced on Tuesday that the FDA has cleared its Tandem Mobi miniature insulin pump for patients with diabetes ages six and up. The company said the device, which is fully controllable from a mobile app, is the world's smallest durable automated insulin delivery (AID) system. Tandem's shares were up as much as 14% on the news.

"Testing the limits of pump miniaturisation, 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," CEO John Sheridan remarked.

Less than half the size of the t:slim X2 pump, Mobi is small enough to fit inside a coin pocket and can be clipped to clothing or worn with an adhesive sleeve. It features a 200-unit insulin cartridge with an on-pump button to provide an alternative to phone control for bolusing insulin. The pump can also be paired with Tandem's existing infusion sets, including a five-inch tubing option specifically designed for Mobi.

Meanwhile, the insulin pump features Tandem's Control-IQ technology, a hybrid closed-loop algorithm that uses compatible continuous glucose monitoring sensor values to predict glucose levels 30 minutes ahead. The technology adjusts insulin delivery every five minutes to help prevent highs and lows, while allowing the user to manually bolus for meals. Control-IQ also delivers automatic correction boluses – up to one an hour – to help prevent hyperglycaemia.

The FDA authorised Tandem's t:slim X2 with Control-IQ technology for automated insulin dosing in 2019, before later clearing the pump to deliver bolus insulin dosing using the t:connect mobile app in 2022. A limited release of the Mobi device is expected to start later this year, with full commercial availability planned for early 2024. 

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