> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# De Novo Authorization for Glycemic Controller
- URL: https://www.fdaweb.com/de-novo-authorization-for-glycemic-controller/
- Published: 2019-12-13T12:00:00.000Z
- Updated: 2026-09-14T15:56:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145721

FDA has authorized the *de novo* marketing of Tandem Diabetes Care’s Control-IQ Technology, an interoperable automated glycemic controller device that adjusts insulin delivery by connecting to an alternate controller-enabled (ACE) insulin 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,” an [FDA release](https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-interoperable-automated-insulin-dosing-controller-designed-allow-more-choices?ref=fdaweb.com) says.  
  
“The Control-IQ Technology controller,” FDA continues, “is a new type of glycemic controller that when used as a system with compatible iCGMs and ACE pumps can be used by patients with Type 1 diabetes to automatically increase, decrease and suspend delivery of basal insulin to the patient based on 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 *de novo* authorization was based on data from a clinical trial of the Control-IQ Technology controller that included 168 participants with Type 1 diabetes. The study showed that the controller determined and commanded safe and effective insulin delivery from a compatible ACE pump based on iCGM readings, with limited user intervention outside of mealtimes. The agency says it also assessed the ability of the controller to communicate with all system parts with appropriate reliability, cybersecurity and fail-safe modes.

Additionally, FDA’ marketing authorization established special controls, which include requirements related to reliability, device interoperability, cybersecurity, and clinical relevance.