Tandem Diabetes Care Automated Insulin Delivery Systems Receive CE Mark for Type 2 Diabetes and Type 1 Diabetes During Pregnancy

Key Terms

ce mark regulatory

A CE mark is a regulatory stamp placed on products to show they meet the European Union’s basic safety, health and environmental rules and can be sold in the European Economic Area. For investors it matters because the mark unlocks market access, affects how quickly a product can generate revenue, and signals regulatory risk and potential compliance costs—think of it as a passport that lets a product enter a large market.

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.

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.

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.

a1c medical

A1C is a blood test that reports average blood sugar over about three months by measuring how much glucose sticks to hemoglobin, a protein in red blood cells. For investors, A1C acts like a long-term scorecard for diabetes treatments, devices and diagnostics: meaningful changes in A1C in clinical studies can affect regulatory approval, insurance coverage and commercial prospects, and thus influence a company's market value.

diabetic ketoacidosis medical

Diabetic ketoacidosis is a serious, sudden complication of uncontrolled diabetes where the body, unable to use sugar for energy, breaks down fat and produces acidic chemicals called ketones, causing very high blood sugar, dehydration and a dangerous change in blood chemistry. It matters to investors because DKA drives hospital admissions, affects demand for diabetes medicines, devices and emergency care, and can influence clinical trial results, regulatory decisions and a company’s costs or liability exposure — like a sudden engine failure forcing expensive repairs.

hyperosmolar hyperglycemic syndrome medical

A serious, acute complication of diabetes where blood sugar rises extremely high and the body becomes severely dehydrated, often leading to confusion, organ stress, or coma if not treated quickly. Think of it like an engine overheating because the fuel is too concentrated and the cooling system has failed; for investors it matters because it drives hospital admissions, urgent care demand, drug and device use, and can influence healthcare costs, insurer payouts and clinical trial or product uptake.

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SAN DIEGO--(BUSINESS WIRE)-- Tandem Diabetes Care, Inc. (Nasdaq: TNDM), a leading insulin delivery and diabetes technology company, today announced receipt of CE mark for expanded indications of its automated insulin delivery (AID) systems in Europe. The t:slim X2 and Tandem Mobi insulin delivery systems running Control-IQ+ AID technology are now approved for use by people with type 1 diabetes during pregnancy and adults with type 2 diabetes.

“These expanded indications underscore the strength of our portfolio and our commitment to bringing innovative diabetes technology to more people worldwide,” said John Sheridan, president and chief executive officer. “By expanding access to our AID technology, we’re broadening our impact and advancing our mission to improve lives across the diabetes community.”

Pregnancy in Type 1 Diabetes

This expanded label indication for use in type 1 diabetes during pregnancy is based on results from the CIRCUIT trial published in Journal of the American Medical Association (JAMA) in October 2025.¹ 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 3.5-7.8 mmol/L (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.

Data from the CIRCUIT Trial will be presented this weekend during a product theater at the 2026 Scientific Sessions of the American Diabetes Association in New Orleans, Louisiana. The presentation takes place on Saturday, June 6 from 10:15 am to 11:00 am Central Time in Product Theater #1.

Adults with Type 2 Diabetes

“The benefits of Control-IQ+ technology were evident across an incredibly diverse population of people with type 2 diabetes, regardless of pre-study glycemic control or experience with diabetes technology,” said Jordan Pinsker, MD, chief medical officer.

This expanded label indication for adults with type 2 diabetes is based on strong clinical evidence from the first large-scale, randomized, controlled study of an automated insulin delivery system in type 2 diabetes (the 2IQP trial), completed in more than 300 people with type 2 diabetes, and published in the New England Journal of Medicine in March 2025.² The trial compared use of a t:slim X2 pump with Control-IQ+ technology to a control group who continued their existing insulin regimen. Both groups used a Dexcom G6 Continuous Glucose Monitoring (CGM) System for the duration of the study. In the pivotal study, people using Control-IQ+ achieved a 0.9% reduction in A1C, compared with 0.3% in the control group, with those entering the study at A1C levels of 9% or higher seeing a 2.3% reduction. The technology was shown to be safe, with low rates of hypoglycemia, no new safety signals identified, and no diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome events reported.

About Tandem Diabetes Care Automated Insulin Delivery Systems

Tandem Diabetes Care manufactures the t:slim X2, the all-in-one insulin delivery system for convenient diabetes management, and the Tandem Mobi, the world's smallest durable AID system. Both systems are powered by Control-IQ+ AID technology to provide proven, best-in-class outcomes. Results from major studies in type 1 and type 2 diabetes, including those published by the New England Journal of Medicine (October 2019, August 2020, March 2023, and March 2025), show immediate and sustained glycemic improvements, including more time in range and improved sleep.

The t:slim X2 insulin pump is currently available in several European countries. The Tandem Mobi system is expected to begin launching in select countries in the second half of 2026. For more information, visit tandemdiabetes.com.

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.

Forward-looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements relate to, among other things, Tandem’s expected timeline and ability to launch the Tandem Mobi system in select European countries. These and other risks are identified and described in greater detail under the “Risk Factors” heading of our most recent Annual Report on Form 10-K. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Actual results could differ materially from those anticipated or projected in the forward-looking statements. Tandem undertakes no obligation to update or review any forward-looking statement in this press release because of new information, future events, or other factors.

Important Safety Information

The t:slim X2 insulin 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. The pump is indicated for the management of Type 1 diabetes mellitus in persons 2 years of age and greater who require a total daily insulin dose of at least 5 units and who weigh at least 9 kilograms, and of Type 2 diabetes mellitus in persons 18 years of age and greater. The pump is intended for use in pregnancy complicated by Type 1 diabetes mellitus, provided the linked CGM system is suitable for use in pregnancy.

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. The pump is intended for single patient use. The pump is intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater who require a total daily insulin dose of at least 5 units and who weigh at least 9 kilograms, and of Type 2 diabetes mellitus in persons 18 years of age and greater. The pump 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 use with a compatible continuous glucose monitor (CGM) and a Tandem insulin pump to automatically increase, decrease, and suspend delivery of basal insulin based on CGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold.

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.

©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.

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¹ 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
² Kudva YC, Raghinaru D, Lum JW, et al. A Randomized Trial of Automated Insulin Delivery in Type 2 Diabetes. N Engl J Med. 2025; 393(6):617-618. doi: 10.1056/NEJMc2507995.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260605572579/en/

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

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

Source: Tandem Diabetes Care, Inc.