Tandem Diabetes Care (NSDQ:TNDM) announced today that it won an expanded pediatric indication from the FDA for its t:slim X2 insulin pump.
The t:slim X2 with Control-IQ technology won FDA clearance for controlling Type 1 diabetes in December, which was followed by a commercial launch in the U.S. the next month. Tandem touts t:slim X2 with Control-IQ as the first and only system cleared to deliver automatic correction boluses in addition to adjusting insulin.
Control IQ is an advanced hybrid closed-loop feature designed to increase time in range (70-180 mg/dL) and simplify diabetes management by preventing highs and lows. It is integrated with the Dexcom (NSDQ:DXCM) G6 continuous glucose monitoring system and requires no fingersticks for calibration.
Previously, the system held approval for people ages 14 and older, but its latest indication from the FDA expands its availability to people ages six and older.
“Nearly 40,000 t:slim X2 users have updated their pump with our revolutionary Control-IQ technology,” Tandem president & CEO John Sheridan said in a news release. “The overwhelmingly positive benefits that people report experiencing can now be offered to a broader group of children with diabetes, which is particularly important as younger people often struggle with their glucose control.”