Clinical Evidence

Clinical studies have demonstrated the safety, efficacy and ease of use of Control-IQ+ Technology

Control-IQ Technology

Apr 2023 – A Meta-Analysis of Randomized Trial Outcomes for the t:slim X2 Insulin Pump with Control-IQ Technology in Youth and Adults from Age 2 to 72
Feb 2023 – Connecting From Afar: Implementation of Remote Data-Sharing for Patients With Type 1 Diabetes on Insulin Pump Therapy
Nov 2022 - Biobehavioral Changes Following Transition to Automated Insulin Delivery: A Large Real-life Database Analysis
Jun 2022 - Evaluation of long-term glycemic outcomes by ethnicity in adults with type 1 diabetes using Control-IQ technology
Jun 2022 - Psychosocial Benefits of using Control-IQ technology: Long-term Outcomes from a Multi-ethnic Adult Cohort with Type 1 Diabetes
Jun 2022 - Long-term Glycemic Control in Adult Participants Using Control-IQ Technology: Real-World Evidence
Jun 2021 - Initiating hybrid closed loop: A program evaluation of an educator-led Control-IQ follow-up at a large pediatric clinic
Apr 2021 - Closed-Loop Insulin Therapy Improves Glycemic Control in Adolescents and Young Adults: Outcomes from the International Diabetes Closed-Loop Trial
Apr 2021 - Safety and Performance of the Tandem t:slim X2 with Control-IQ Automated Insulin Delivery System in Toddlers and Preschoolers
Mar 2021 - One Year Real-World Use of Control-IQ Advanced Hybrid Closed-Loop Technology
Aug 2020 - A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes
May 2020 - Glycemic Outcomes of Use of Closed-Loop Control vs PLGS on Type 1 Diabetes: A Randomized Controlled Trial
Oct 2019 - Six-Month Randomized, Multi-Center Trial of Closed-Loop Control in Type 1 Diabetes
May 2019 - Closed-Loop Control in Adolescents and Children During Winter Sports: Use of the Tandem Control-IQ Artificial Pancreas System
Apr 2019 - Successful At-Home Use of the Tandem Control-IQ Artificial Pancreas System in Young Children During a Randomized Controlled Trial
Feb 2019 - The International Diabetes Closed-Loop (IDCL) Study: Planned Pivotal Trials of Closed-Loop Control on an Embedded System and a Mobile System
Dec 2018 - First Look at Control-IQ: A New Generation Automated Insulin Delivery System
Aug 2017 - Closed-Loop Control During Intense Prolonged Outdoor Exercise in Adolescents With Type 1 Diabetes: The Artificial Pancreas Ski Study
Nov 2015 - Measures of Risk and Glucose Variability in Adults Versus Youths
May 2014 - Overnight Glucose Control With an Automated, Unified Safety System in Children and Adolescents With Type 1 Diabetes at Diabetes Camp
Jan 2014 - Confusion Regarding Duration of Insulin Action: A Potential Source for Major Insulin Dose Errors by Bolus Calculators

Basal-IQ Technology

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, Humalog, or Lyumjev 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.

Important Safety Information

RX ONLY. The t:slim X2 pump and Basal-IQ technology are intended for single patient use for the management of diabetes mellitus in persons 6 years of age and greater. The t:slim X2 pump and Basal- IQ technology are indicated for use with NovoLog or Humalog U-100 insulin.

Basal-IQ technology: Basal-IQ technology is intended for use with a compatible integrated continuous glucose monitor (iCGM, sold separately) and alternate controller enabled (ACE) pump to automatically suspend delivery of insulin based on iCGM readings and predicted glucose values. The bolus calculator is indicated for the management of diabetes by people with diabetes by calculating an insulin dose or carbohydrate intake based on user entered data. Users of the t:slim X2 pump and Basal-IQ technology must: be able and willing 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, 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.

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