First and Only System in the U.S. Available for Use During Pregnancy with Type 1 Diabetes
In pregnancy-specific target range1
In pregnancy-specific target range1
mg/dL lower in mean glucose1
A Tandem Diabetes Care Specialist will help you get started.
Frequently Asked Questions
Can people with type 1 diabetes have a healthy pregnancy?
Yes. Many people with type 1 diabetes have healthy pregnancies and healthy babies. Pregnancy does require more intensive glucose management because blood glucose targets are lower and insulin needs can change throughout pregnancy. Working closely with your healthcare team and using diabetes technology can help you stay on track throughout your pregnancy journey.
Is Control-IQ+ cleared for use during pregnancy?
Yes. Control-IQ+ is cleared for use during pregnancy in people with type 1 diabetes when used with a compatible continuous glucose monitor (CGM)* that is indicated for pregnancy. It is the first and only commercially available automated insulin delivery (AID) system in the United States cleared for use during pregnancy. Control-IQ+ is available on both the t:slim X2 insulin pump and Tandem Mobi system.
How does Control-IQ+ help manage glucose levels during pregnancy?
Control-IQ+ uses glucose readings from a compatible CGM to help predict glucose levels and automatically adjust insulin delivery throughout the day and night. By increasing, decreasing, or stopping basal insulin delivery — and delivering an AutoBolus† when needed — Control-IQ+ can help support glucose management during pregnancy.
What clinical evidence supports the use of Control-IQ+ during pregnancy?
The Control-IQ+ pregnancy indication is supported by evidence from the CIRCUIT study, a randomized clinical trial evaluating the use of Control-IQ technology during pregnancy in women with type 1 diabetes.1 Study participants using Control-IQ technology spent more time in the pregnancy-specific target range while also reducing time above range, lowering average glucose levels, and decreasing glucose variability.
Should I adjust my pump settings during pregnancy?
Insulin needs can change significantly throughout pregnancy. Over time, your healthcare provider may recommend adjusting settings such as basal rate, insulin-to-carbohydrate ratio, and Correction Factor over time. Always consult your healthcare provider before making therapy changes.
How do I learn whether a Tandem insulin pump is right for me during pregnancy?
Talk with your healthcare provider about your diabetes management goals, lifestyle, and treatment preferences. Together, you can determine whether insulin pump therapy and Control-IQ+ are appropriate for your needs during pregnancy.
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Test drive the easy-to-use interfaces of either the Tandem Mobi system or t:slim X2 insulin pump, with no obligation.
* CGM sold separately.
† If glucose values are predicted to be above 180 mg/dL (or 10.0 mmol/L), Control-IQ+ technology calculates an AutoBolus using the Personal Profile settings and a target of 110 mg/dL (or 6.1 mmol/L) and delivers 60% of that value.
Reference
1. Donovan LE, et al. JAMA. 2025;334(24):2176-2185.
Important Safety Information
RX ONLY.
Indications for Use
Tandem Mobi system: The Tandem Mobi insulin pump with interoperable technology (the pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The pump is indicated for use in persons 2 years of age and greater.
t:slim X2 insulin pump: The t:slim X2 insulin pump with interoperable technology (the pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The pump is indicated for use in persons 2 years of age and greater.
Control-IQ+ technology: Control-IQ+ technology is intended for use with compatible integrated continuous glucose monitors (iCGM, sold separately) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. Control-IQ+ technology is intended for the management of type 1 diabetes mellitus in persons 2 years of age and greater and of type 2 diabetes mellitus in persons 18 years of age and greater.
Warning: Control-IQ+ technology should not be used in anyone under the age of 2 years old with type 1 diabetes or under the age of 18 years old with type 2 diabetes. It should also not be used in patients who require less than a total daily insulin dose of 5 units of insulin per day or who weigh less than 20 pounds (9 kilograms), as those are the required minimum values needed for Control-IQ+ to operate safely.
Users of the pump and Control-IQ+ must: use the insulin pump, iCGM, and all other system components in accordance with their respective instructions for use. Failure to follow these instructions for use could result in an over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events. Visit tandemdiabetes.com/safetyinfo for additional important safety information.