Control-IQ+ automated insulin delivery technology from Tandem Diabetes Care now available for people ages 2 years and older with type 1 diabetes and adults with type 2 diabetes
– Enhanced features extend automated insulin delivery (AID) to people ages 2 years and older with type 1 diabetes and adults with type 2 diabetes –
SAN DIEGO, March 18, 2025--(BUSINESS WIRE)--Tandem Diabetes Care, Inc. (Nasdaq: TNDM), a leading insulin delivery and diabetes technology company, today announced the United States commercial launch of Control-IQ+ technology, the latest generation of the company’s advanced hybrid closed-loop algorithm. Control-IQ+, compatible with both the t:slim X2 insulin pump and Tandem Mobi System, is now available for people with type 1 diabetes ages 2 years and older and adults with type 2 diabetes. Pumps pre-loaded with the updated software are now shipping to new customers, and all eligible, in-warranty Tandem customers will have access to the new features via remote software update free of charge.
"These new features allow for even greater levels of personalization and flexibility within our algorithm, while still receiving high marks for ease of use across a diverse population of users," said John Sheridan, president and chief executive officer. "We are proud to offer this life-changing technology to millions more people living with diabetes."
New features of the Control-IQ+ algorithm include:
Expanded weight (20-440 lbs.) and total daily insulin (5-200 units) parameters to accommodate a wider range of insulin requirements.
Enhanced extended bolus up to 8 hours with Control-IQ+ turned on, for better management for meals with delayed glucose rise or prolonged eating.
New Temp Basal Rate adjustments allowed when Control-IQ+ is active, to address short-term glucose needs, such as exercise, stress, or illness, while Control-IQ+ is turned on.
Control-IQ+ builds on the existing features of Tandem’s industry-leading Control-IQ algorithm, which in addition to adjusting insulin every 5 minutes based on predicted glucose values, also uses a unique AutoBolus™ feature that calculates and delivers a correction bolus to help with missed meal boluses. Control-IQ+ is also the only AID algorithm that allows users to program extended boluses of up to 8 hours while automation is active to better manage delayed glucose rises or prolonged eating.
"The benefits of AID are proven - better sleep, fewer adverse events and better glucose control - any one of these outcomes can be life changing for children living with diabetes and their families," said Dr. Paul Wadwa, director of the pediatric clinic at the Barbara Davis Center for Diabetes and professor of pediatrics at the University of Colorado School of Medicine. "Control-IQ+ is easy to start, use, and personalize. It’s exciting to see continued advancement in the field that allows this technology to impact even more lives."
All eligible, in-warranty Tandem users can access the software update for their pump by logging into their Tandem Source account: https://source.tandemdiabetes.com.
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 @TandemDiabetes on Facebook, Instagram, LinkedIn, TikTok, and X.
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, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. These forward-looking statements relate to, among other things, the anticipated timing for the commercial launch of the t:slim X2 pump and the Tandem Mobi system with Control-IQ+ technology and our ability to offer the Control-IQ+ software update for current Tandem pump users. These statements are subject to numerous risks and uncertainties, including our ability to commence commercial scale manufacturing of the Tandem pump with Control-IQ+ technology and the risk that we may encounter other challenges that may delay the commercial launch of Tandem pumps with Control-IQ+ technology, as well as other risks identified in our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and other documents that we file with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. 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
RX ONLY. The t:slim X2 pump with interoperable technology (the pump) and Control-IQ+ technology (Control-IQ+) are intended for single patient use. The pump and Control-IQ+ are indicated for use with NovoLog or Humalog U-100 insulin. 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.
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.
