Even with advanced systems such as Control-IQ technology, you are still responsible for actively managing your diabetes. Control-IQ technology does not prevent all high and low blood glucose events. The system is designed to help reduce glucose variability, but it requires your accurate input of information, such as meals and periods of sleep or exercise. Control-IQ technology will not function as intended unless you use all system components, including your CGM, infusion sets and pump cartridges, as instructed. Importantly, the system cannot adjust your insulin dosing if the pump is not receiving CGM readings. Because there are situations and emergencies that the system may not be capable of identifying or addressing, always pay attention to your symptoms and treat according to your healthcare provider’s recommendations.
* A Dexcom G6 transmitter can only be paired with one medical device (either a Dexcom receiver or t:slim X2 pump) and one consumer device (phone or tablet) at the same time. Internet connectivity required for data sharing. To view a list of compatible devices, visit dexcom.com/compatibility.
† CGM sold separately.
‡ Additional feature updates may not be currently available for the t:slim X2 insulin pump with Control-IQ technology. Control-IQ technology is available only to customers who reside in the United States or Canada, and other select geographies. Future updates for all or some of Tandem’s products may not be developed and may not be offered everywhere and would be subject to applicable regulatory approvals. Software updates are only available to customers who are in warranty at the time they update their pump. Additional training may be required to access certain future software updates. Charges may apply. Tandem may discontinue select software and features over time at its discretion.
Important Safety Information
RX ONLY. The t:slim X2 pump and Control-IQ technology are intended for single patient use. The t:slim X2 pump and Control-IQ technology are indicated for use with NovoLog or Humalog U-100 insulin. t:slim X2 insulin pump: The t:slim X2 insulin pump with interoperable technology is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in people 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 individuals 6 years of age and greater. Control-IQ technology: Control-IQ technology is intended for use with a 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 6 years of age and greater.
Warning: Control-IQ technology should not be used by anyone under the age of 6 years old. It should also not be used in patients who require less than 10 units of insulin per day or who weigh less than 55 pounds.
Control-IQ technology is not indicated for use in pregnant women, people on dialysis, or critically ill patients. Do not use Control-IQ technology if using hydroxyurea. Users of the t:slim X2 pump and Control-IQ technology must: 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. The t:slim X2 pump must be removed before MRI, CT, or diathermy treatment. Visit
tandemdiabetes.com/safetyinfo for additional important safety information.