Tandem Diabetes Care, Inc. announced that its next-generation automated insulin delivery (AID) algorithm, Control-IQ+ technology, has received clearance from the United States Food and Drug Administration (FDA). This clearance permits its use by people with type 2 diabetes aged 18 and older. Control-IQ+ was already cleared for use by individuals with type 1 diabetes, and this expansion significantly broadens its addressable market.
The Control-IQ+ technology builds upon the existing Control-IQ algorithm and includes enhancements to accommodate expanded weight and total daily insulin ranges. This expanded label indication for type 2 diabetes is based on results from a recently completed pivotal trial involving over 300 people with type 2 diabetes, comparing the t:slim X2 pump with Control-IQ+ to existing multiple daily injection regimens, demonstrating positive outcomes.
Tandem expects Control-IQ+ to be available for new and existing customers in the United States in March 2025. This regulatory milestone allows Tandem to bring its proven AID technology to millions more people living with diabetes, particularly those with type 2 who rely on intensive insulin therapy and have historically had limited management options.
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