Tandem Diabetes Care Inc., an insulin delivery and diabetes technology company, announced U.S. Food and Drug Administration (FDA) clearance for the Tandem Mobi insulin pump for people with diabetes age 6 and up, expanding the company’s portfolio of products. The Tandem Mobi is fully controllable from a mobile app and is reportedly the world’s smallest durable automated insulin delivery system.
“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,” says John Sheridan, Tandem Diabetes Care president and chief executive officer. “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.”
Key Tandem Mobi System Features
The Tandem Mobi features a 200-unit insulin cartridge and an on-pump button that provides an alternative option to phone control for bolusing insulin. Additional features include:
- Multiple Wear Options – Less than half the size of the t:slim X2 pump, Tandem Mobi can fit in a coin pocket, be clipped to clothing, or worn on-body with an adhesive sleeve (sold separately).
- Detachable Infusion Sets – Compatible with all existing Tandem-branded infusion sets manufactured by the Convatec Group, including a new five-inch tubing option made just for Tandem Mobi. 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.
- AID Compatibility – Designed for use as part of an automated insulin delivery (AID) system, the Tandem Mobi features Control-IQ technology.
- Mobile App Control – Full iOS mobile control through a user’s compatible iPhone
- Modern Technology – Inductive charging and capable of wireless remote software updates via a compatible smartphone
A limited release of Tandem Mobi is expected to start in late 2023 with full commercial availability planned in early 2024.
About Control-IQ Advanced Hybrid Closed-Loop Technology
The Tandem Mobi will be offered with Control-IQ technology, a hybrid-closed loop algorithm for use by people with type 1 diabetes age 6 and up. Control-IQ technology uses compatible continuous glucose monitoring (CGM) sensor values to predict glucose levels 30 minutes ahead and adjust insulin delivery every 5 minutes to help prevent highs and lows, while still allowing the user to manually bolus for meals. It can also deliver automatic correction boluses (up to one an hour) to help prevent hyperglycemia. Real-world data shows immediate and sustained glycemic improvements — including more time in range and better sleep. Results from major studies of Control-IQ technology were published by the New England Journal of Medicine in October 2019, August 2020, and March 2023.