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First Interoperable, Automated Insulin Dosing Controller Is Approved

FDA creates new regulatory classification with this approval

The FDA has approved Tandem Diabetes Care Inc. to market the Tandem Diabetes Care Control-IQ Technology, a device that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM). This is the first such controller 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.

Patients can use the Control-IQ Technology controller to automatically increase, decrease and suspend delivery of basal insulin based on their insulin delivery history, iCGM readings and predicted glucose values. The controller can also automatically deliver a specific amount of insulin when the glucose value is predicted to exceed a predefined amount.

The FDA reviewed data from a clinical trial of the Control-IQ Technology controller that included 168 participants with type 1 diabetes. Patients were randomized to use either the Control-IQ Technology controller installed on a Tandem t:slim X2 insulin pump, or a CGM and insulin pump without the Control-IQ Technology controller. 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.

With this authorization the FDA has created a new regulatory classification for this type of device, which means that subsequent devices of the same type with the same intended use may go through FDA's 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

Source: FDA, Dec. 13, 2019

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