San Diego-based Tandem can now market the miniature, durable automated insulin delivery system with Control-IQ+ technology in Europe.
According to the filing, the company intends to pursue additional regulatory and pre-commercial activities now. That includes securing in-country registrations and reimbursement for Mobi in European markets. It then plans to begin its European commercial rollouts by the end of 2025.
Tandem launched Mobi, the world’s smallest, durable automated insulin delivery (AID) system in the U.S. last year. It initially received FDA clearance for people with diabetes ages six and up in July 2023. The system then received expanded clearance for pediatric indications last summer.
Mobi features a 200-unit insulin cartridge and an on-pump button to provide an alternative to phone control for insulin boluses. It comes in at less than half the size of the flagship Tandem pump system, the t:slim X2 pump. Mobi can fit in a coin pocket, clip to clothing or go on the body with an adhesive sleeve.
It now utilizes Tandem’s Control-IQ+ technology, an advanced hybrid closed-loop automated insulin delivery feature that predicts and helps prevent high and low blood sugar. Control-IQ leads to improved time in range throughout the day and night. Tandem unveiled the next-generation algorithm earlier this year.
The company built upon its established Control-IQ algorithm to add expanded weight and total daily insulin parameters. It also has enahnced extended bolus capabilities and enabled better meal management. The technology also features an AutoBolus option that calculates and delivers a correction bolus to help with missed meal boluses.
