Tandem Diabetes Care’s Control-IQ+ Automated Insulin Delivery Technology Now FDA Cleared for Pregnancy in Type 1 Diabetes

Key Terms

automated insulin delivery medical

A system that links a glucose sensor, an insulin pump, and control software so insulin is adjusted automatically to keep blood sugar near a target range, similar to a smart thermostat that regulates room temperature. It matters to investors because it replaces manual dosing with continuous, data-driven care, which can drive device sales, recurring subscription software services, better health outcomes, and regulatory interest—factors that affect market growth and company valuation.

type 1 diabetes mellitus medical

An autoimmune condition in which the body’s immune system destroys insulin-producing cells in the pancreas, leaving the body unable to regulate blood sugar; think of insulin as a key that opens cells to allow sugar in, and type 1 diabetes removes that key. It matters to investors because it creates a lifelong need for treatments, devices and care, making therapies, insulin delivery technology and related regulatory approvals important drivers of long-term revenue and clinical risk in healthcare investments.

glycemic medical

Relating to blood sugar levels or the way foods and treatments affect those levels; often used to describe how quickly carbohydrates raise glucose in the bloodstream. Investors pay attention because products, drugs, or labels that change glycemic response can alter consumer demand, medical costs, and regulatory scrutiny—similar to how fuel quality affects engine performance, small shifts in blood-sugar control can reshape markets in food, pharmaceuticals, and healthcare.

randomized controlled trial medical

A randomized controlled trial is a research method that tests the effects of a new idea or treatment by randomly dividing participants into two groups: one that receives the treatment and one that does not. This approach helps ensure that the results are fair and unbiased, providing clear evidence about whether the treatment actually works. Investors value such trials because they offer reliable information that can influence decision-making and reduce uncertainty.

multiple daily insulin injections medical

A treatment regimen in which a person with diabetes gives themselves several insulin shots each day to control blood sugar, typically before meals and at bedtime. For investors, it signals a sustained demand for injectable insulin products, delivery devices and patient support services, and it can affect adherence, treatment costs and sales forecasts much like a recurring subscription model that drives steady revenue streams.

continuous glucose monitoring medical

Continuous glucose monitoring is a system that tracks blood sugar levels in real-time throughout the day and night. It provides constant updates, similar to a car's dashboard showing speed and fuel level at all times. For investors, advancements in this technology can signal progress in health monitoring devices, which may influence the growth and valuation of companies in the healthcare sector.

hbA1c medical

A1c (HbA1c) is a blood test that measures how much sugar has stuck to red blood cells over the past two to three months, giving a single number that reflects average blood glucose control—think of it as a running average score for blood sugar. Investors watch A1c because it’s a common clinical measure used to judge whether diabetes drugs, devices or care programs work, influence regulatory approvals, treatment guidelines and market demand.

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First and only commercially available AID technology for pregnancy use in the U.S.

SAN DIEGO--(BUSINESS WIRE)-- Tandem Diabetes Care, Inc. (Nasdaq: TNDM), a leading insulin delivery and diabetes technology company, today announced that the United States Food and Drug Administration (FDA) has cleared Control-IQ+ automated insulin delivery (AID) technology for use in pregnancy complicated by type 1 diabetes mellitus. Control-IQ+ powers both insulin delivery systems from Tandem – the t:slim X2 and Tandem Mobi, the first and only commercially available AID systems cleared for use during pregnancy in the United States.

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

This expanded label indication for use in type 1 diabetes during pregnancy¹ is based on results from the CIRCUIT trial published in Journal of the American Medical Association (JAMA) in October 2025.² Participants in this multi-center, randomized controlled trial were assigned to use a t:slim X2 insulin pump with Control-IQ technology or to continue their multiple daily insulin injections or insulin pump with continuous glucose monitoring. The Control-IQ group experienced 12.6% more time in the pregnancy glucose target range 63-140 mg/dL, approximately 3 hours more per day, compared to those using their standard therapy, from 16 weeks gestation to the end of pregnancy.¹ Maternal and neonatal outcomes were similar in both groups overall but favored those using Control-IQ.

“In the CIRCUIT trial, glycemic improvements were found across all sites and baseline HbA1c ranges, regardless of whether an insulin pump or multiple daily insulin injections were used at enrollment. Marked glycemic improvements occurred within the first week of initiation of Control-IQ that persisted for the duration of pregnancy,” said Dr. Lois Donovan, principal investigator of the CIRCUIT study and Clinical Professor at the University of Calgary.

Tandem Diabetes Care will be performing a series of training events and webinars for healthcare providers related to pregnancy and type 1 diabetes management. The first event will be the Tandem product theater at the American Diabetes Association 2026 Scientific Sessions meeting in New Orleans, Louisiana, in June, discussing the study results.

Results from major studies of Control-IQ technology, including those published by the New England Journal of Medicine in October 2019, August 2020, March 2023, and March 2025, show immediate and sustained glycemic improvements, including more time in range and improved sleep.

About Tandem Diabetes Care, Inc.

Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers. The Company’s pump portfolio features the Tandem Mobi system and the t:slim X2 insulin pump, both of which feature Control-IQ+ advanced hybrid closed-loop technology. Tandem Diabetes Care is based in San Diego, California. For more information, visit tandemdiabetes.com.

Follow @TandemDiabetesCare on TikTok and @TandemDiabetes on Facebook, Instagram, LinkedIn, and X.

©2026 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care, the Tandem logo, Control-IQ+, Tandem Mobi and t:slim X2 are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries. All third-party marks are the property of their respective owners.

Important Safety Information

RX ONLY. The Tandem Mobi system, the t:slim X2 pump with interoperable technology and Control-IQ+ technology are intended for single patient use. The pumps and Control-IQ+ are indicated for use with NovoLog or Humalog U-100 insulin. 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 intended for single patient, home use and requires a prescription. The pump is indicated for use in individuals 6 years of age and greater. t:slim X2 insulin pump: 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. Control-IQ+ technology is intended for use in pregnancy complicated by Type 1 diabetes mellitus, provided the linked CGM system is suitable for use in pregnancy. Control-IQ+ technology is intended for single patient use and requires a prescription.

WARNING: Control-IQ+ 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.

¹ Provided the linked continuous glucose monitoring system is suitable for pregnancy.
² Donovan LE, Lemieux P, Dunlop AD, et al. Closed-Loop Insulin Delivery in Type 1 Diabetes in Pregnancy: The CIRCUIT Randomized Clinical Trial. JAMA. 2025;334(24):2176-2185. doi:10.1001/jama.2025.19578

View source version on businesswire.com: https://www.businesswire.com/news/home/20260427815489/en/

Media Contact:
858-366-6900
media@tandemdiabetes.com

Investor Contact:
858-366-6900
IR@tandemdiabetes.com

Source: Tandem Diabetes Care, Inc.