Officials in America have approved a system, called Control-IQ, for closed-loop insulin delivery for people with type 1 diabetes.
The Control-IQ technology by Tandem Diabetes Care can be used with different types of insulin pumps and glucose sensors.
It will be available to people with diabetes in American from January after the US Food and Drug Administration (FDA) authorised the marketing of the system.
The Control-IQ technology is the ‘controller’ in a closed loop system. It encompasses the computing and algorithms which determine how an insulin pump should respond to the changes in glucose levels measured by a continuous glucose monitor.
In the context of the system, the insulin pump is an alternate controller-enabled insulin pump (ACE pump) and the monitor is an integrated continuous glucose monitor (iCGM).
The Control-IQ is the first technology of its kind to be compatible with other devices, with the FDA approval paving the way for iCGMs and ACE pumps to be used with as part of computerised automated glycemic controller and automated insulin dosing (AID) systems. An AID system normally is made up of a pump and CGM as well as software to control the system and compatible devices.
Dr Tim Stenzel is the director of the Office of In Vitro Diagnostics and Radiological Health, which is part of FDA’s Center for Devices and Radiological Health.
He said: “Today’s action continues the agency’s ongoing efforts to work with the diabetes community to help ensure the safety and efficacy of innovative and customizable diabetes management systems that may help patients better tailor their treatments to their individual needs.
“The marketing authorization of this first stand-alone interoperable automated glycemic controller also allows substantially equivalent controller technologies that are developed for diabetes in the future to go through the 510(k) review process, helping to promote timely patient access to innovative technologies that can improve their care and quality of life.”
As part of the FDA approval, a clinical trial of the Control-IQ controller was reviewed. A total of 168 people with type 1 diabetes, with participants split into two groups, one using the Control-IQ controller installed on a Tandem t:slim X2 insulin pump and another where people used a CGM and insulin pump without Control-IQ.
The study demonstrated that the controller determines and commands safe and effective insulin delivery from a compatible ACE pump based on iCGM readings, with limited user intervention outside of mealtimes. The FDA also assessed the ability of the controller to communicate with all parts of the system with appropriate reliability, cybersecurity and fail-safe modes.
The FDA notes that technology is not without risks and such a system could result in errors including delay of insulin delivery or incorrect insulin delivery, leading to risks of hypoglycemia, hyperglycemia or diabetic ketoacidosis.
