T:SLIM X2 INSULIN PUMP #1 Prescribed Insulin Pump in Canada

* Individual symptoms, situations, circumstances and results may vary.^† Bolus defined as a large dose of a drug administered by rapid injection, as opposed to infusion. If glucose values are predicted to be above 10.0 mmol/L, Control-IQ technology calculates a correction bolus using the Personal Profile settings and a target of 6.1 mmol/L and delivers 60% of that value. ^‡ CGM sold separately.

References

1. Beck RW, et al. Diabetes Technol Ther. 2023;25(5):329-342.

2. Dexcom G7 CGM System User Guide, 2024.

3. Brown SA, et al. N Engl J Med. 2019;381(18):1701-1717.

4. Kudva YC, et al. Diabetes Technol Ther. 2021;23(10):673-683.

5. dQ&A Canada Patient Panel H2 2023

This product may not be right for you. Always read and follow the label.

Important Safety Information

The t:slim X2 insulin pump with Control-IQ technology (the System) consists of the t:slim X2 insulin pump, which contains Control-IQ technology, and a compatible continuous glucose monitor (CGM, sold separately). 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 people requiring insulin. The t:slim X2 insulin pump can be used solely for continuous insulin delivery and as part of the System. When used with a compatible CGM, the System can be used to automatically increase, decrease, and suspend delivery of basal insulin based on CGM sensor readings and predicted glucose values. The System can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. The pump and the System are indicated for use in individuals 6 years of age and greater. The pump and the System are intended for single user use. The pump and the System are indicated for use with NovoRapid, Admelog, Trurapi, or Humalog U-100 insulin. The System is intended for the management of Type 1 diabetes.

Warning: Control-IQ technology should not be used by anyone under the age of 6 years old. It should also not be used in users who require less than 10 units of insulin per day or who weigh less than 25 kilograms.

The System is not indicated for use in pregnant women, people on dialysis, or critically ill users. Do not use the System if using hydroxyurea.

Users of the pump and the System must: be willing and able to use the insulin pump, CGM, and all other system components in accordance with their respective instructions for use; test blood glucose levels as recommended by their healthcare provider; demonstrate adequate carb-counting skills; maintain sufficient diabetes self-care skills; see healthcare provider(s) regularly; and have adequate vision and/or hearing to recognize all functions of the pump, including alerts, alarms, and reminders. If your CGM readings do not match your symptoms or expectations, use a blood glucose meter to make diabetes management decisions. The t:slim X2 pump must be removed before MRI, CT, or diathermy treatment. Visit tandemdiabetes.com/safetyinfo for additional important safety information.