Tandem crosses FDA finish line with nod for miniaturized insulin pump

The next big thing on Tandem Diabetes Care’s technology slate is actually a very small thing.

The Mobi insulin pump—which is the company's smallest device to date and, it claims, the smallest automated insulin delivery system in the world—has secured an FDA clearance, Tandem announced Tuesday while teeing up the U.S. launch of the technology for the coming months.

That rollout will start with a limited release near the end of this year, before opening up to full commercial availability in early 2024.

Tandem submitted the pump for FDA review last fall, when CEO John Sheridan described it as “the first novel form factor launched in our space since we introduced t:slim a decade ago.” The Mobi was cleared for use by people with diabetes ages six and older.

The pump, which holds 200 units of insulin, is about half the size of Tandem’s flagship t:slim devices. It’s meant to provide a more discreet, easy-to-wear option for users, since it can be clipped onto clothing, worn in an adhesive sleeve or even slipped into the small coin pocket of a pair of jeans. The device is water-resistant and can be charged wirelessly.

Users control insulin delivery and enter bolus doses either by using a button on the pump itself or through an app on their personal iPhone. The mobile app also serves as a vehicle to remotely and wirelessly deliver software updates to the pump.

The Mobi system can be used with all of Tandem’s existing infusion sets—which connect an insulin pump to a user’s body—including a five-inch tubing system specially designed for use with the Mobi pump.

Mobi pumps are also equipped with Tandem’s existing Control-IQ technology. The algorithm takes in blood sugar readings from a compatible continuous glucose monitor, then uses those data to predict how a user’s glucose levels may change as far as 30 minutes in advance.

Control-IQ makes adjustments to users’ insulin delivery every five minutes to help avoid highs and lows, and it can automatically deliver correction bolus doses of insulin if glucose levels are at risk of dropping too low—though users still must program their own mealtime boluses.

While the Mobi pump is cleared for use by anyone at least six years old who uses insulin to manage their diabetes, Control-IQ has been authorized only for people with Type 1 diabetes. But Tandem may be looking to change that: It presented results of a study late last year showing that it could improve blood sugar management for those with Type 2 diabetes, too.

After using the Control-IQ algorithm for six weeks, the 30 participants in the study saw their time in range improve by an average of 15%, adding about 3.6 hours’ worth of time spent at a healthy glucose level per day.