FDA Approves Control-IQ+ for Pregnancy

If you’re pregnant or thinking of becoming pregnant, here’s a big reason to celebrate: Control-IQ+ is now officially FDA-approved for use in pregnancy for people with existing T1D. 

On April 28, 2026, Tandem Diabetes Care announced that its Control-IQ+ automated insulin delivery (AID) system was FDA-approved for use in pregnancy for people with existing type 1 diabetes (T1D), making it the first AID system to be officially cleared for this population. 

Why is this important?

Until now, the use of AID systems in pregnancy for people with pre-existing insulin-dependent type 1 diabetes was often recommended “off-label.” 

Off-labeling is a practice that is common in the US. It happens when a healthcare provider prescribes a device or medication to treat a condition outside of its FDA approval. The practice is legal, with 1 in 5 prescriptions in the U.S. written for off-label use. Still, a lack of formal approval often creates hesitation for both healthcare providers and people living with T1D, especially when it comes to pregnancy, when you want to minimize risks.

What did Control-IQ+ receive FDA approval for?

Getting the green light from the FDA shows the power and safety of AID systems in some of our most vulnerable populations: pregnant people with T1D. 

This latest FDA approval is for t:slim X2 and Tandem Mobi AID systems, both of which are powered by Control-IQ+.

The FDA approval is based on clinical findings from the CIRCUIT trial, which was published in JAMA in October 2025. In the study, the group using the Control-IQ+ AID system experienced a 12.6% increase in time spent within pregnancy-specific glucose targets of between 63 mg/dL and 140 mg/dL—about three additional hours per day.

And it didn’t take long to see improvements in glucoselevels. Researchers noted that glucose levels improved in the first week of people using the Control-IQ+ system, and that improved glucose levels continued throughout the rest of their pregnancies. 

How does Control-IQ+ help pregnant people living with T1D?

Receiving FDA approval for an AID system use in pregnancy will help more healthcare providers adopt the view that automated insulin delivery systems are safe and effective for all populations. 

With more widespread use of the technology, pregnant people living with type 1 diabetes can have healthier pregnancies and births. Researchers reported comparable health outcomes for parents and babies, but Control-IQ+ users saw better results.

Tandem Diabetes Care chief medical officer Dr. Jordan Pinsker said, “Glycemic goals are tighter during pregnancy. The higher time in the pregnancy-specific glucose range seen with Control-IQ+ can help improve pregnancy outcomes.”

How does Control-IQ+ make pregnancy safer for people with T1D?

Type 1 diabetes in pregnancy may put people at higher risk for not only cesarean sections, but also pre-eclampsia, macrosomia, worsening retinopathy in people with the condition, higher fetal birth weight, premature birth and neonatal hypoglycemia. 

A T1D pregnancy requires extra fetal monitoring and close management of pre-existing diabetes. Having more access to technology, including the use of AID systems, is an incredible step forward in improving the health and well-being of pregnant people with T1D and their children. 

What to do next

If you’re pregnant or planning a pregnancy and are interested in using Control-IQ+, talk with your healthcare provider. Access to Tandem’s systems is already available, and this new approval may make it easier to explore whether it’s a good fit for your care plan.

Making pregnancy safer and healthier for people with T1D is a worthy goal. Although this FDA approval is a huge step forward, pregnant people with type 1 diabetes should have multiple AID system options to choose from. T1D makes for a high-risk pregnancy, and any steps to alleviate risk and harm through the use of technology are a win for the diabetes community. 

Help advance T1D pregnancy care

If you’re currently pregnant (or planning to be) and living with type 1 diabetes, the Jaeb Center for Health Research is enrolling participants for “T1D Pregnancy & Me,” an observational study exploring how tools like continuous glucose monitors and AID systems support diabetes management during pregnancy. The goal is to better understand how these technologies work in real life, and where they fall short, so healthcare providers can better manage diabetes during pregnancy and improve outcomes for both mothers and babies.