What's Happening?
Tandem Diabetes Care, Inc. has received clearance from the U.S. Food and Drug Administration (FDA) for its Control-IQ+ automated insulin delivery technology to be used during pregnancy in individuals with type 1 diabetes. This marks the first and only
commercially available automated insulin delivery (AID) system approved for such use in the United States. The technology, which powers the t:slim X2 and Tandem Mobi insulin pumps, is designed to automatically adjust insulin delivery based on continuous glucose monitor readings. The approval is based on the CIRCUIT trial, which demonstrated significant improvements in maintaining glucose levels within the target range during pregnancy. The trial showed that participants using the Control-IQ technology spent 12.6% more time in the target glucose range compared to those using standard insulin therapy.
Why It's Important?
The FDA's clearance of Control-IQ+ for use during pregnancy is a significant advancement in diabetes management, particularly for pregnant women with type 1 diabetes. Maintaining optimal glucose levels during pregnancy is crucial for the health of both the mother and the developing fetus. The technology's ability to automatically adjust insulin delivery can help achieve tighter glycemic control, potentially improving pregnancy outcomes. This development could lead to broader adoption of automated insulin delivery systems, reducing the burden of diabetes management for patients and healthcare providers. It also highlights the ongoing innovation in diabetes care technology, which aims to improve quality of life and health outcomes for individuals with diabetes.
What's Next?
Tandem Diabetes Care plans to conduct training events and webinars for healthcare providers to educate them on the use of Control-IQ+ technology in managing type 1 diabetes during pregnancy. The first of these events will take place at the American Diabetes Association 2026 Scientific Sessions in New Orleans. As healthcare providers become more familiar with this technology, it is expected that more patients will have access to this advanced diabetes management tool. Additionally, ongoing research and development in the field may lead to further enhancements in automated insulin delivery systems, potentially expanding their use to other patient populations.
