On June 17, Tandem Diabetes announced FDA clearance of an expanded pediatric indication for the Tandem t:slim X2™ insulin pump with Control-IQ™ technology in children ages six and older. This device was initially only authorized for use in people 14 and older. Simply put: more people now have access to this life-changing technology.
“Today’s clearance by the U.S. Food and Drug Administration (FDA) extending the pediatric indication of the t:slim X2 Insulin Pump with Control-IQ Advanced Hybrid Closed-Loop Technology is another big win for the T1D community and especially for our youngest members,” said Sanjoy Dutta, Ph.D., Breakthrough T1D Vice President, Research. “With this technology now available to children ages six and above, families have an additional option to explore as they seek to find the system that best suits their needs.”
The data for the clearance came from the International Diabetes Closed Loop Protocol-5 (DCLP5), a six-month study of children ages 6-13. This study was funded by the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) with funds from the Special Diabetes Program (SDP), for which Breakthrough T1D is the primary advocate. The results are definitive: Control-IQ™ helps children with T1D do better.
Per Tandem’s announcement, children in the six-month trial experienced:
- Increased time in range overall (67% for those on Control-IQ™ compared to 53% in the control group)
- Increased time in range overnight (80% for those on Control-IQ™ compared to 54% in the control group)
Control-IQ™ first received FDA authorization for people 14 and older on December 13, 2019. Critically, at the time, it became the first algorithm authorized as an interoperable automated glycemic controller, meaning the algorithm could be a component of an open protocol, or interoperable, artificial pancreas system.
Breakthrough T1D has been a leader in the development of artificial pancreas systems since starting the Artificial Pancreas Project over 15 years ago. Through years of research funding, collaboration with regulatory agencies and leadership in the field, Breakthrough T1D has helped accelerate the development of transformative therapies that make life better for people living with T1D. Breakthrough T1D has also been a leading advocate for coverage, affordability and choice for diabetes technology and the insulin people need through our Coverage2Control campaign. People with T1D need options, which is why Breakthrough T1D continues to call upon United Healthcare to lift its restrictions on insulin pump coverage, and cover all FDA authorized devices.
Today is a big win for the T1D community that will help a lot of children (and their parents!) sleep better at night.
