* CGM sold separately.
† If glucose values are predicted to be above 180 mg/dL, Control-IQ technology calculates a correction bolus using the Personal Profile settings and a target of 110 mg/dL and delivers 60% of that value.
‡ Our mobile apps require acompatible smartphone model and operating system(sold separately). Only available to pump users who reside in the U.S.
§ Do not wear or place your pump more than 12 inches (30.5 cm) above your infusion site. Doing so may result in over delivery of insulin.
^ Tandem Mobi integration with Dexcom G7 is under development. The safety and effectiveness of Dexcom G7 with Tandem Mobi has not yet been established. Tandem Mobi is intended for use with Dexcom G6 CGM.
** Tested at 8 feet for 2 hours (IP28 rating).
†† Future updates for all or some Tandem 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 software updates. Charges may apply. Tandem may discontinue select software and features over time at its discretion.
References
1. Breton MD, Kovatchev BP. One year real-world use of the Control-IQ advanced hybrid closed-loop technology. Diabetes Technol Ther. 2021;23(9):601-608. doi: 10.1089/dia.2021.0097.
2. dQ&A US Diabetes Connections Patient Panel Report; Net Promoter Score; Jan. 2019-Sept. 2023: P.49, Sept. 2023.
Important Safety Information
RX ONLY.
Indications for Use
Tandem Mobi system: The Tandem Mobi insulin pump with interoperable technology (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 intended for single patient, home use and requires a prescription. The pump is indicated for use in individuals 6 years of age and greater.
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 intended for single patient use. The pump is indicated for use with NovoLog or Humalog U-100 insulin. 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 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. Control-IQ technology is intended for single patient use. Control-IQ technology is indicated for use with NovoLog or Humalog U-100 insulin.
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 a Tandem insulin 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 Tandem pump must be removed before MRI, CT, or diathermy treatment. Visittandemdiabetes.com/safetyinfofor additional important safety information.
TheTandem Sourceplatform is intended for use by individuals with diabetes mellitus who use Tandem Diabetes Care insulin pumps, their caregivers, and their healthcare providers in home and clinical settings. The Tandem Source platform supports diabetes management through the display and analysis of information uploaded from Tandem insulin pumps.
