Tandem Diabetes Care received Food and Drug Administration clearance for its Control-IQ+ algorithm in Type 2 diabetes. The automated insulin delivery (AID) system can pull data from glucose monitors and integrate with Tandem’s insulin pumps, automatically calculating how much basal insulin patients should receive.
The expanded indication increases access for people with Type 2 diabetes who use Tandem’s t:slim X2 tubed pump and Tandem Mobi, a smaller form-factor pump.
CEO John Sheridan told investors in a Wednesday earnings call that the expanded indication covers all people with Type 2 diabetes who take insulin, more than doubling Tandem’s total addressable market in the U.S.
Tandem modified the Control-IQ algorithm, including expanding weight ranges and total daily insulin ranges. The company plans a pilot launch of the updated software beginning in March, said Chief Commercial Officer Mark Novara.
Tandem will also share results next month of a 300-person randomized, controlled trial that supported the FDA’s decision at the International Conference on Advanced Technologies & Treatments for Diabetes.
Tandem’s device is the second AID system cleared by the FDA for people with Type 2 diabetes, after Insulet’s Omnipod 5 received an expanded indication last summer.
Insulet CEO Jim Hollingshead told investors in a Feb. 20 call that as competitors emerge in the Type 2 market, “we are very confident in our position and think we have a clear right to win.”
Insulet executives expect Type 2 to be an important part of the company’s growth, with those users representing more than 30% of new customers in the fourth quarter. CFO Ana Maria Chadwick said the label expansion is expected to “contribute meaningfully to revenue in 2025,” but did not provide a specific breakdown. Insulet estimates that about 2.5 million people in the U.S. with Type 2 diabetes take multiple daily doses of insulin, and another 3 million people take basal insulin only.
Both companies have work ahead as AID devices in the past have typically been focused on Type 1 diabetes.
“It has not until now really been accepted to use … insulin pump therapy in the Type 2 patient population,” Hollingshead told investors. “And so we have to go out and drive awareness.”
Tandem’s Novara said the company will focus on expanding its pharmacy sales channel and establishing broader coverage under Medicare. Currently, many commercial insurance plans cover insulin pumps for Type 2 similarly as they do for Type 1 diabetes, said Tandem CFO Leigh Vosseller.
“From a Medicare perspective, there’s still some onerous requirements,” Vosseller said, adding that the company and its peers have sought to get a national coverage determination on the docket for review.
Tandem reported revenue of $940.2 million in 2024, representing year-over-year growth of 26%. For 2025, Tandem expects sales of from $997 million to $1 billion.
Insulet’s revenue grew year over year by 22% to $2.1 billion in 2024. The firm expects sales to grow between 16% and 20% in 2025.
