The FDA Dec. 13 approved Tandem Diabetes Care's insulin device, designed to help diabetes patients tailor their treatments to their individual needs.
The device, called the Control-IQ Technology controller, automatically adjusts insulin delivery by connecting to a controller-enabled insulin pump and integrated continuous glucose monitor. It is the first such controller that can be used with other diabetes devices, according to the FDA.
Tandem's device is designed to help patients with Type 1 diabetes manage their insulin. It automatically increases, decreases or suspends delivery of insulin based on a patient's insulin delivery history.
The device was tested in a clinical trial of 168 patients with Type 1 diabetes and showed that the controller determines and commands safe and effective insulin delivery. However, incorrect insulin delivery is still a risk if the device malfunctions, the FDA warned.
Read the full news release here.