In a report written for JDRF by Brian Herrick, Tandem Diabetes has gained FDA clearance of an expanded paediatric indication for the Tandem t:slim X2 insulin pump with Control-IQ technology in children ages six and older. The device was initially only authorized for use in people 14 and older. Simply put: more people now have access to this life-changing technology. 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 JDRF is the primary advocate. The results were definitive: Control-IQ helps children with T1D do better.
Children in the six-month trial experienced an increase in time in range overall (67% for those on Control-IQ compared to 53% in the control group), and increased time in range overnight (80% for those on Control-IQ™ compared to 54% in the control group). This will help a lot of children (and their parents) sleep better at night.
When Control-IQ first received FDA authorization for people 14 and older on December 2019 it was the first algorithm authorized as an interoperable automated glycaemic controller, meaning that the algorithm could be a component of an open protocol, or interoperable, artificial pancreas system.
JDRF has been a leader in the development of artificial pancreas systems since starting the Artificial Pancreas Project 15 years ago helping to accelerate the development of transformative therapies that make life better for people living with T1D.