FDA Authorizes Tandem Diabetes Care Control-IQ Technology

FDA Approves Tandem’s  t:slim X2 Insulin Pump with Control-IQ for Children Age 6 and Up


The U.S. FDA has announced clearance of an expanded pediatric indication for the Tandem’s  t:slim X2™ insulin pump with Control-IQ™ technology to children age 6 and older. The product was previously approved for ages 14 and older. Control-IQ technology is an advanced hybrid closed-loop feature designed to increase time in range (70-180 mg/dL).

Control-IQ technology helps simplify diabetes management for younger patients by adjusting insulin delivery to help prevent highs and lows, automatically delivering correction boluses up to once per hour, and offering exercise and sleep-specific features. Integrated with Dexcom G6 continuous glucose monitoring (CGM), Control-IQ technology requires no fingersticks for calibration or diabetes treatment decisions.

In a recent six-month study of children age 6 to 13 using the t:slim X2 pump with Control-IQ technology, sensor time in range (TIR) increased to 67 percent from 53 percent compared to those in the control group using sensor-augmented pump (SAP) alone (p<0.001). Overnight, children using Control-IQ technology in the same study stayed in range an average of 80 percent of the time, compared to 54 percent in the control group. This data from the International Diabetes Closed Loop Protocol-5 (DCLP5) study, funded by the National Institutes of Health (NIH), was presented earlier this year at the 13th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) in Madrid, Spain.

Source: tandemdiabetes.com/news-releases



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