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FDA OKs Insulin Pump for Pregnant Diabetics
28 Apr
Summary
- FDA approved Control-IQ+ for pregnant type 1 diabetics.
- Trial showed increased glucose control in pregnant users.
- Outcomes were favorable for Control-IQ system users.
The U.S. Food and Drug Administration (FDA) has granted approval for Tandem Diabetes Care's Control-IQ+ automated insulin delivery technology, enabling its use in pregnant individuals diagnosed with type 1 diabetes mellitus. This clearance extends to the t:slim X2 and Tandem Mobi insulin delivery systems, both powered by Control-IQ+.
The approval stems from findings within the CIRCUIT randomized controlled trial, published in JAMA in October 2025. Pregnant participants with type 1 diabetes were assigned to either the t:slim X2 pump with Control-IQ or their existing diabetes management regimen.
Results indicated that pregnant individuals using Control-IQ saw a 12.6% increase in time spent within the recommended 63mg/dL-140mg/dL glucose range. This translates to approximately three extra hours daily within target levels from week 16 of gestation through delivery.
While maternal and neonatal outcomes were generally similar between the Control-IQ group and the control group, researchers noted more favorable results among those utilizing the Control-IQ system. Dr. Jordan Pinsker highlighted that tighter glycemic goals during pregnancy can be better achieved with Control-IQ, potentially improving outcomes.
