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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.
