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

The U.S. Food and Drug Administration (FDA)  announced clearance of an expanded pediatric indication for the t:slim X2™ insulin pump with Control-IQ™ technology to children age six 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).1

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.2

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 a 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.3

Control-IQ technology uses CGM readings to predict glucose values 30 minutes ahead. If glucose values are predicted to drop below 112.5 mg/dL, basal insulin delivery is reduced, and when predicted to be below 70 mg/dL, basal insulin delivery is stopped. If glucose values are predicted to be above 160 mg/dL in the next 30 minutes, basal insulin will be increased to help keep glucose in range (70-180 mg/dL).1

If glucose values are predicted to be above 180 mg/dL, Control-IQ technology calculates a correction bolus with a target of 110 mg/dL and delivers 60 percent of that value. It will do this up to once an hour as needed.4

With Dexcom G6 CGM integration, the Control-IQ feature works with no fingersticks required for mealtime dosing or calibration.2 Other benefits of the Dexcom G6 CGM include an extended 10-day wear, acetaminophen blocking,5 and the ability to share real-time CGM data with up to 10 followers.6

 

For additional product and safety information, or to begin the order process, visit http://tandemdiabetes.com/controliq