Clinical Evidence

Systems like the t:slim X2 insulin pump with Basal-IQ technology and the t:slim X2 insulin pump with Control-IQ technology are not substitutes for active diabetes management. For example, users still must bolus for meals. Basal-IQ technology is designed to predict and help prevent lows, but it cannot prevent all lows and Basal-IQ technology does not predict high glucose events. Control-IQ technology is designed to predict and help prevent low and high glucose events, but it cannot prevent all highs and lows, and Control-IQ requires that users accurately input information, such as meals and periods of sleep or exercise. The Basal-IQ and Control-IQ features rely on continuous CGM readings and will not be able to predict glucose levels and adjust insulin dosing if the CGM is not working properly or is unable to communicate with the pump. Users must be sure to always use their pump, cartridges, CGM, and infusion sets as instructed and check them regularly to make sure they are working properly. Users should always pay attention to their symptoms, actively monitor and manage glucose levels, and treat according to prescriber recommendations.

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

Important Safety Information

The pump and each System below is indicated for use in individuals 6 years of age and greater. The pump and each System is intended for single user use. The pump and each System is indicated for use with NovoRapid, Admelog, Trurapi, or Humalog U-100 insulin.

The t:slim X2 insulin pump with Basal-IQ technology (the Basal-IQ System) consists of the t:slim X2 insulin pump, which contains Basal-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 Basal-IQ System. When used with a compatible CGM, the t:slim X2 insulin pump with Basal-IQ technology can be used to suspend insulin delivery based on CGM sensor readings.

The t:slim X2 insulin pump with Control-IQ technology (the Control-IQ 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 Control-IQ System. When used with a compatible CGM, the t:slim X2 insulin pump with Control-IQ technology can be used to automatically increase, decrease, and suspend delivery of basal insulin based on CGM sensor readings and predicted glucose values. The t:slim X2 insulin pump with Control-IQ technology can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. The t:slim X2 insulin pump with Control-IQ technology 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.

Do not use the t:slim X2 insulin pump with Control-IQ technology if using hydroxyurea. Neither System is indicated for use in pregnant women, people on dialysis, or critically ill users. Users of the pump and either 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. The t:slim X2 pump must be removed before MRI, CT, or diathermy treatment. Visit www.tandemdiabetes.com/safetyinfo for additional important safety information.