Tandem Mobi Insulin Pump, Billed as World's Smallest Insulin Pump, Receives FDA Clearance

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has granted clearance to the Tandem Mobi insulin pump for use in people aged 6 years and older with diabetes.

Announced by Tandem Diabetes Care on July 11, 2023, the Tandem Mobi is billed as the world’s smallest durable automated insulin delivery device, with the device less than half the size of the t:slim X2 pump and able to fit in a coin pocket, be clipped to clothing, or worn on-body with an adhesive sleeve. The device also features a 200 unit insulin cartridge and is fully controllable from a mobile app or an on-pump button.¹

“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 John Sheridan, president and chief executive officer of Tandem Diabetes Care.¹ “Through this expansion, we are delivering on our commitment to bring greater choice, along with the proven benefits of Tandem’s technology, to more people living with diabetes.”

In their announcement, Tandem Diabetes Care highlighted multiple key features of the Tandem Mobi insulin pump, including detachable infusion sets, compatibility with other devices, and the ability for wireless software updates via a compatible smartphone. As it pertains to the detachable infusion sets, Tandem Diabetes Care pointed out the Tandem Mobi is compatible with all existing Tandem-branded infusion sets manufactured by the Convatec Group and the infusion sets allow users to temporarily disconnect from their pump for convenience and provide the flexibility of more than 30 mix-and-match infusion site and tubing length combinations.¹

As part of their highlighting Tandem Mobi’s compatibility with automated insulin delivery (AID) systems, Tandem Diabetes Care noted the pump is designed for use as part of an AID system and comes with Control-IQ technology.¹ On the Tandem Diabetes Care website, Control-IQ technology is described as being designed to help increase time in range using continuous glucose monitoring values to predict glucose levels 30 minutes ahead and adjust insulin delivery accordingly, including delivery of automatic correction boluses as needed.² In addition to the aforementioned features, Tandem also pointed out the Tandem Mobi allows for full iOS mobile control through a compatible iPhone.¹

According to the announcement from Tandem Diabetes Care, availability of the Tandem Mobi is expected to begin in late 2023 with full commercial availability planned in early 2024. Interested clinicians or consumers can sign up for notifications regarding availability at: TandemDiabetes.com/Mobi.¹

This clearance is just one of several clearances or approvals for Tandem Diabetes Care products in recent years. In December 2019, the FDA clearance of the t:slimX2 insulin pump made it the first device to receive the FDA’s interoperable automated glycemic controller designation.³ In February 2022, the company announced the FDA had granted clearance to the t:connect mobile app, which made it the first first-ever FDA-cleared smartphone application capable of initiating insulin delivery on both iOS and Android operating systems.⁴

References:

1. Tandem Diabetes Care. Tandem Mobi, World’s smallest durable insulin delivery system, receives FDA clearance. Tandem Diabetes Care. July 11, 2023. Accessed July 12, 2023. https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-mobi-worlds-smallest-durable-insulin-delivery-system.
2. Tandem Diabetes Care. Control-IQ hybrid closed-loop system for people with diabetes: Tandem diabetes care. Tandem Diabetes Care. Accessed July 12, 2023. https://www.tandemdiabetes.com/providers/products/control-iq.
3. Tandem Diabetes Care. Tandem Diabetes Care announces FDA clearance of the t:slim X2 insulin pump with Control-IQ advanced hybrid closed-loop technology. Tandem Diabetes Care. December 13, 2019. Accessed July 12, 2023. https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-care-announces-fda-clearance-tslim-x2-insulin.
4. Tandem Diabetes Care. Tandem Diabetes Care announces FDA clearance for the t:slim X2 insulin pump to bolus using the t:Connect Mobile app. Tandem Diabetes Care. February 16, 2022. Accessed July 12, 2023. https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-care-announces-fda-clearance-tslim-x2-insulin-0.