FDA clears interoperable insulin pump for pediatric use
The FDA cleared an expanded pediatric indication for the t:slim X2 interoperable insulin pump, lowering its indicated age for use in children from age 14 years to age 6 years, according to a press release from Tandem.
The t:slim X2 pump can be used with the Control-IQ interoperable, automated insulin dosing algorithm, the first dosing controller that can be used with other interoperable diabetes devices, allowing people with diabetes to create a customizable automated insulin delivery system.
“Nearly 40,000 t:slim X2 users have updated their pump with our revolutionary Control-IQ technology,” John Sheridan, president and CEO of Tandem Diabetes Care, said in the 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.”
As Healio previously reported, the FDA in December first authorized marketing of the Control-IQ interoperable, automated insulin dosing algorithm, paving the way for integrated continuous glucose monitoring systems and alternate controller-enabled infusion pumps, or ACE insulin pumps, to be used with an interoperable automated glycemic controller as a complete automated insulin dosing system, also known as an artificial pancreas.
Control-IQ technology helps simplify diabetes management for younger patients by adjusting insulin delivery to help prevent hyperglycemia and hypoglycemia, automatically delivering correction boluses up to once per hour, and offering exercise and sleep-specific features, according to the release. The algorithm is integrated with the Dexcom G6 CGM and requires no finger sticks for calibration or diabetes treatment decisions.
In data from the International Diabetes Closed Loop Protocol-5 (DCLP5) study, funded by the NIH, children with type 1 diabetes aged 6 to 13 years using the t:slim X2 pump with Control-IQ technology experienced an increase in sensor time in range from 53% to 67% during 6 months compared with participants in the control group using a sensor-augmented pump alone (P < .001). Overnight, children using Control-IQ technology in the same study stayed in the recommended glucose range an average of 80% of the time vs. 54% for controls.
The data were presented at the International Conference on Advanced Technologies and Treatments for Diabetes in Madrid earlier this year.
In a statement, JDRF called the extended indication “another big win” for the type 1 diabetes community.
“With this technology now available to children ages 6 [years] and above, families have an additional option to explore as they seek to find the system that best suits their needs,” the organization said in the statement. “As part of our mission to improve the lives of those affected by type 1 diabetes, JDRF has been a leader in artificial pancreas research for more than 15 years and partnered with the FDA to establish regulatory pathways to ensure artificial pancreas technology gets into the hands of the type 1 diabetes community. ... Today’s announcement is yet another reason why health plans should cover all FDA authorized diabetes management tools to help people with type 1 diabetes manage this life-threatening disease.”