Clinical Evidence

Clinical studies have demonstrated the safety, efficacy and ease of use of Control-IQ and Basal-IQ technologies on the t:slim X2 insulin pump.

Control-IQ Technology

Oct 2021 – Candidate Selection for Hybrid Closed Loop Systems
Jun 2021 – Real-World Use of a New Hybrid Closed Loop Improves Glycemic Control in Youth with Type 1 Diabetes
Dec 2020 – Automated Insulin Delivery: Easy Enough to Use in Primary Care?
Nov 2020 – Clinical Management and Pump Parameter Adjustment of the Control-IQ Closed-loop Control System
Nov 2020 – Closed-Loop Insulin Therapy Improves Glycemic Control in Adolescents and Young Adults: Outcomes from the International Diabetes Closed-Loop (iDCL) Trial
Nov 2020 – Significant Reduction in Time Below Range (Hypoglycemia) in People with Type 1 Diabetes Using an Advanced Hybrid Closed-Loop System
Sep 2020 – Psychosocial Impact of Control-IQ Technology in Pediatric Users with Type 1 Diabetes: Real-World Insights (View Abstract)
Mar 2021 – One Year Real-World Use of Control-IQ Advanced Hybrid Closed-Loop Technology
Feb 2021 – A Virtual Training Program for the Tandem t:slim X2 Insulin Pump: Implementation and Outcomes
Jan 2021 – Pediatric Diabetes “Initiating Hybrid Closed Loop…”
Aug 2020 – Significant Improvements in Time Above Range Using Control-IQ Technology: Real-World Insights (View Abstract)
Dec 2020 – Extended Use of the Control-IQ Closed-Loop Control System in Children With Type 1 Diabetes
Jun 2020 – Glycemic Outcomes for People with Type 1 and Type 2 Diabetes Using Control-IQ Technology: Real-World Data
Jun 2020 – Control-IQ Technology in the Real World: The First 30 Days
Jun 2020 – A Clinical Review of the t:slim X2 Insulin Pump

Basal-IQ Technology

Aug 2020 - Basal-IQ Technology in the Real-World: Satisfaction and Reduction of Diabetes Burden in Individuals With Type 1 Diabetes
Jul 2020 - Real-World Improvements in Hypoglycemia in an Insulin-Dependent Cohort Pre- and Post-Tandem Basal-IQ Technology Remote Software Update
Jun 2020 - A Clinical Review of the t:slim X2 Insulin Pump
May 2020 - Psychosocial Benefits of Using Basal-IQ Predictive Low Glucose Suspend Technology in a Real-World Setting: Results From Pediatric Patients With Type 1 Diabetes
Aug 2019 - Reducing Hypoglycemia in the Real World: A Retrospective Analysis of Predictive Low-Glucose Suspend Technology in an Ambulatory Insulin-Dependent Cohort
Oct. 2018 – Predictive Low Glucose Suspend Reduces Hypoglycemia in Adults, Adolescents, and Children With Type 1 Diabetes in an At-Home Randomized Crossover Study

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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.