Tandem’s Automated Glycemic Controller Gets FDA OK

The FDA authorized the marketing of Tandem Diabetes Care’s Control-IQ technology, an interoperable glycemic controller that makes automatic adjustments to insulin delivery.

The Control-IQ is the first stand-alone controller of its kind that can be used with other diabetes devices that are also designed to be integrated into a customizable diabetes management system for automated insulin delivery. It connects to a controller-enabled insulin pump and a continuous glucose monitor to provide an automated insulin dosing system.

The controller can be used by type 1 diabetes patients to automatically increase, decrease and suspend delivery of insulin based on the insulin delivery history, continuous glucose readings and predicted glucose values.

The marketing authorization “also allows substantially equivalent controller technologies that are developed for diabetes in the future to go through the 510(k) review process,” said Tim Stenzel, director of CDRH’s Office of In Vitro Diagnostics and Radiological Health.