Control-IQ TechnologyPredicts and helps prevent highs and lows

* 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. An Automatic Correction Bolus will not occur within 60 minutes of a bolus that has been delivered or cancelled.

‡ If glucose alerts and CGM readings do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions.

§ As measured by CGM.

^ Time in range is defined as 70-180 mg/dL.

** #1 rating claim based on dQ&A US Diabetes Connections Patient Panel Report, Q3 2023 (July-Sept. 2023). $0 out of pocket claim based on direct orders from Tandem customers with commercial insurance from 1/1/2022-12/31/2022. Data on file. Actual cost may vary and is subject to individual insurance coverage. Cost per month claim calculation reflects the average monthly out-of-pocket cost for pump and disposables necessary to utilize Tandem pump therapy over the life of the 48-month pump warranty. Assumes consumption of 10 infusion sets and cartridges per month.

†† Bolus delivery from the t:connect mobile app requires a compatible smartphone model and operating system, an app update, a remote software update on the t:slim X2 insulin pump and additional training. Only available to pump users who reside in the United States.

‡‡ 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.

References

1. Brown SA, Kovatchev BP, Raghinaru D, et al. Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes. N Eng J Med. 2019;381(18):1701-1717. doi: 10.1056/NEJMoa1907863.

2. Brown SA. Clinical acceptance of the artificial pancreas: Glycemia outcomes from a 6-month multicenter RCT. Poster presented at 79th Scientific Sessions of the American Diabetes Association; June 7-11, 2019; San Francisco, CA.

3. dQ&A US Diabetes Connections Patient Panel Report, Q3 2023 (July-Sept. 2023).

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.