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FDA Authorizes Marketing of Automated Insulin Dosing Controller

THURSDAY, Dec. 19, 2019 (HealthDay News) — The U.S. Food and Drug Administration recently approved marketing of an interoperable automated glycemic controller device, the Tandem Diabetes Care Control-IQ Technology, the agency announced last week.

The device automatically adjusts insulin delivery through connection to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM). According to the FDA, this controller is the first that can be used with other diabetes devices that are meant to be integrated into a diabetes management system for automated insulin delivery. With this marketing authorization, the FDA notes iCGMs and ACE pumps can be used with an interoperable automated glycemic controller as a complete automated insulin dosing (AID) system. Patients with type 1 diabetes can use the Control-IQ Technology controller with compatible iCGMs and ACE pumps to automatically increase, decrease, and suspend delivery of basal insulin based on insulin delivery history, iCGM readings, and predicted glucose values. The controller can also automatically deliver insulin when the glucose value is predicted to exceed a predefined number.

Approval was based on data from a clinical trial of 168 patients with type 1 diabetes randomly assigned to use 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. Data revealed the controller determined and commanded safe and effective insulin delivery from a compatible ACE pump based on iCGM readings. The controller was also assessed for its ability to communicate with the entire system with appropriate reliability, cybersecurity, and fail-safe modes. However, the FDA notes that despite these assessments, there is still a risk for delayed insulin delivery.

Other risks associated with the interoperable controller include incorrect insulin delivery due to loss of communication between connected devices or from cybersecurity issues.

Marketing authorization of the Control-IQ Technology controller was granted to Tandem Diabetes Care Inc.

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