FDA Clears Tandem’s Control-IQ+ for Pregnancy in Type 1 Diabetes — Tandem Diabetes Care, Inc.

Event summary

FDA cleared Tandem’s Control-IQ+ for pregnancy in type 1 diabetes on April 27, 2026.
Clearance based on CIRCUIT trial results published in JAMA October 2025 showing 12.6% more time in target glucose range.
Control-IQ+ now powers both t:slim X2 and Tandem Mobi insulin delivery systems for pregnancy use.
Tandem to host training events, including a product theater at the American Diabetes Association 2026 Scientific Sessions.

The big picture

Tandem’s FDA clearance for Control-IQ+ in pregnancy represents a strategic milestone in automated insulin delivery, addressing a critical unmet need in type 1 diabetes management. The approval positions Tandem as a leader in advanced hybrid closed-loop technology, potentially driving higher adoption rates and revenue growth. This move aligns with broader industry trends toward personalized and automated healthcare solutions.

What we're watching

Market Expansion: How Tandem will leverage this clearance to expand its market share in diabetes management technology.
Clinical Adoption: The pace at which healthcare providers adopt Control-IQ+ for pregnancy management in type 1 diabetes.
Competitive Dynamics: Whether this approval will pressure competitors to accelerate their own pregnancy-specific diabetes technology developments.