Trusted Partners Tandem and FreeStyle Libre 2 Plus Sensor

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+ technology 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.

Tandem t:slim mobile app: The feature set available within the Tandem t:slim mobile app is dependent on the pump software version and the compatible smartphone’s model and operating system (OS).

• The Display and Data Upload feature set provides a secondary display of pump and continuous glucose monitoring (CGM) information, including display of your pump alerts and alarms, and enables wireless uploading of pump and CGM data to the Tandem cloud through an internet or wireless data connection. Standard carrier data rates may apply.
• The Bolus Delivery plus Display and Data Upload feature set additionally allows users to request, stop, and cancel a bolus on the pump from the Tandem t:slim mobile app. At least one smartphone security setting must be enabled to utilize the Bolus Delivery feature of the Tandem t:slim mobile app.
• WARNING: Always rely on your pump to make therapy decisions when using a smartphone that is incompatible with the Bolus Delivery feature.
• PRECAUTIONS: Always rely on your pump to make therapy decisions if using a smartphone that is incompatible, the smartphone is lost or damaged, or the smartphone loses Bluetooth® connectivity with your pump. Important pump alerts and alarms are only received as app notifications when enabled and the app is either active or running in the background.