Tandem Diabetes Care’s t:slim X2 insulin pump with Control-IQ+ automated insulin delivery (AID) technology has received multiple new indication approvals from Health Canada.
The regulatory clearance permits the device to be used by adults with type 2 diabetes and individuals with type 1 diabetes during pregnancy and for the AID technology’s integration with Abbott’s FreeStyle Libre 3 Plus sensor.
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Tandem Diabetes Care stated that commercial availability for the new indications and sensor integration is scheduled for Q2 2027.
Once compatible with FreeStyle Libre 3 Plus, which can be worn for up to 15 days, Tandem t:slim users will be able to review trend data through the the t:slim mobile application.
Tandem Diabetes’ president and CEO John Sheridan said: “These expanded indications for our Canadian customers underscore the strength of our portfolio and our commitment to bringing innovative diabetes technology to more people worldwide. By increasing access to our AID technology, we’re broadening our impact and advancing our mission to improve lives across the diabetes community.”
The expanded indication for adults with type 2 diabetes was supported by data from the 2IQP trial (NCT05785832), published in the New England Journal of Medicine in March 2025.
The randomised study assessed over 300 participants, comparing the t:slim X2 pump using Control-IQ+ against a control group on existing insulin therapy, with both cohorts using Dexcom’s G6 continuous glucose monitoring (CGM) system.
Patients using Control-IQ+ registered a 0.9% reduction in A1C compared to 0.3% in the control arm, while those with baseline A1C levels of 9% or higher experienced a 2.3% decrease.
The trial reported low hypoglycaemia rates, no diabetic ketoacidosis, no hyperosmolar hyperglycaemic syndrome, and no new safety signals.
Approval for use during pregnancy in type 1 diabetes was based on findings from the multi-centre, randomised controlled CIRCUIT trial (NCT04902378), published in the Journal of the American Medical Association (JAMA) in October 2025.
From 16 weeks of gestation through delivery, participants using the t:slim X2 with Control-IQ+ spent 12.6% more time within the target glucose range of 3.5–7.8mmol/L (63–140mg/dL). This represents an increase of around three hours each day, compared with those on standard therapies.
