Tandem t:slim X2 Insulin Pump with Control-IQ Technology

Quick Reference Guide

Introduction

This Quick Reference Sheet will teach you how to turn Control-IQ technology on. Control-IQ technology is an advanced feature of the t:slim X2 insulin pump designed to help manage diabetes by automatically adjusting insulin delivery based on continuous glucose monitoring (CGM) data.

Note: These instructions are provided as a reference tool for pump users and caregivers who are already familiar with the use of an insulin pump and with insulin therapy in general. Not all screens are shown. For more detailed information on the operation of the t:slim X2 pump, please refer to its user guide.

How it Works

The t:slim X2 insulin pump with Control-IQ technology uses continuous glucose monitoring (CGM) values to predict glucose levels 30 minutes ahead and automatically adjust insulin every 5 minutes. This powerful algorithm can decrease or stop basal insulin delivery to help prevent lows. It can also increase insulin delivery and deliver automatic correction boluses to help avoid highs.

Pump Tip: Automatic correction boluses will not be delivered while Sleep is enabled but can be delivered once per hour when the Exercise Activity is enabled.

Insulin Adjustments

Control-IQ technology can adjust insulin delivery in several ways:

[Basal Rate Delivery] from Personal Profile
[Increase Basal] insulin delivery
[Auto Correction Bolus] delivery
[Decrease Basal] insulin delivery
[Stop Basal] insulin delivery

Activity States

Control-IQ technology features two optional settings that adjust treatment ranges for more targeted control:

? Sleep Activity enabled: When enabled, the system narrows and lowers the range of treatment values to 6.25-6.7 mmol/L.
? Exercise Activity enabled: When enabled, a tighter and higher range of treatment values from 7.8-8.9 mmol/L is used.

Turning On Control-IQ Technology

Follow these steps to enable Control-IQ technology:

From the Home screen, tap [Options Button].
Tap [My Pump Button].
Tap [Control-IQ Button].
Toggle the Control-IQ switch to 'On' [Toggle Control-IQ Switch]. Note: User must have an active Personal Profile with CARBS turned on and an active CGM* session to turn Control-IQ technology on.
Enter the user's weight and average daily insulin use. Note: Total Daily Insulin should be an estimate of the total basal and bolus insulin the user requires in a 24-hour period.
Tap [Save Settings Button] to save the settings.
The pump will display that Control-IQ technology is on. [Control-IQ Status: On].

Glucose Management Overview

The Control-IQ technology system monitors predicted glucose levels and adjusts insulin delivery accordingly. The graph below illustrates how insulin delivery changes based on predicted glucose trends:

A graph displays predicted glucose levels over time, showing a target range (e.g., 3.9-10.0 mmol/L). Below the graph, a timeline illustrates insulin delivery adjustments: 'Decreases', 'Stops', 'Maintains', 'Delivers', and 'Increases' corresponding to predicted glucose levels. The graph shows a scenario where predicted glucose levels are high, leading to insulin delivery increases.

Important Safety Information

WARNING: Control-IQ technology should not be used by anyone under the age of six 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.

The t:slim X2 insulin pump with Control-IQ technology (the System) consists of the t:slim X2 insulin pump 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. When used with a compatible CGM, the System can be used to automatically increase, decrease, and suspend delivery of basal insulin based on CGM sensor readings and predicted glucose values. The System can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold.

The pump and the System are indicated for use in individuals six years of age and greater and are intended for single user use with U-100 insulin only.

The System is not indicated for use in pregnant women, people on dialysis, or critically ill users. Do not use the System if using hydroxyurea.

Users of the pump and the 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.
Have adequate vision and/or hearing to recognize all functions of the pump, including alerts, alarms, and reminders.

The t:slim X2 pump and the CGM transmitter and sensor must be removed before MRI, CT, or diathermy treatment.

For additional important safety information, visit tandemdiabetes.com/safetyinfo.

For more detailed information on the operation of the t:slim X2 pump, please refer to its user guide. For information on Control-IQ technology use, visit tandemdiabetes.com/tslimx2-use.

About Air Liquide Healthcare

Air Liquide Healthcare is a world leader in medical gases, home healthcare, hygiene products and healthcare specialty ingredients. It aims to provide customers in the continuum of care from hospital to home with medical products, specialty ingredients and services that contribute to protecting vulnerable lives.

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