Control-IQ Technology: Now cleared for ages six and up

 

Last December, we announced FDA clearance of Control-IQ™ technology for the t:slim X2™ insulin pump, our advanced hybrid closed-loop system that predicts and helps prevent highs and lows. Now we have more great news: Control-IQ technology has been cleared for ages six and up, providing kids with the same opportunity as adults to lessen the burden of managing their diabetes.

If you’re unfamiliar with how Control-IQ technology works, it is designed to help increase time in range (70-180 mg/dL)* using Dexcom G6 continuous glucose monitoring (CGM) values to predict glucose levels 30 minutes ahead and adjusting insulin delivery accordingly; including delivery of automatic correction boluses up to once per hour.

t:slim X2 insulin pump with Control-IQ technology

Like Basal-IQ® technology, Control-IQ technology for the t:slim X2 pump requires zero fingersticks – a bonus for any parent with kids who hate being poked and prodded.

Control-IQ technology also offers a number of other features that benefit young lifestyles, including automatic correction boluses that can help address the unpredictable and sometimes fluctuating needs kids face throughout the day, as well as optional Sleep and Exercise Activities that adjust treatment values for more targeted control.

You may be wondering, how did Control-IQ technology perform in clinical trials? In one specifically for users age 6-13, we found that on average, overnight time in range* was 80 percent.

Kids in the trial using Control-IQ technology also experienced fewer overnight lows than those not using Control-IQ technology.1 If you’re concerned about your child staying in range throughout the night, Control-IQ technology was designed to help.

So whether your kid is giving it their all during soccer practice or snoozing away after a long day of activities, Control-IQ technology has features designed to help keep them in range.

Control-IQ technology requires a prescription from your child’s healthcare provider. If you already have a t:slim X2 pump, you can request the software update in the customer portal by following these steps. The final step is downloading the software update to your t:slim X2 insulin pump, and enjoying all the features of our latest generation technology.

If you don’t have a t:slim X2 pump, and your healthcare provider is supportive, you can start the process online or call us at (877) 801-6901. After completing the order process and your one-on-one pump training with one of our pump trainers, you can begin using your t:slim X2 pump with Control-IQ technology.

If you’d like to explore the features of Control-IQ technology and how it can help your kid better manage their diabetes, please visit our website.

Responsible Use of Basal-IQ and Control-IQ Technologies

Systems like the t:slim X2 insulin pump with Basal-IQ technology and the t:slim X2 insulin pump with Control-IQ technology are not substitutes for active diabetes management. For example, users still must bolus for meals. Basal-IQ technology is designed to predict and help prevent lows, but it cannot prevent all lows and Basal-IQ technology does not predict high glucose events. Control-IQ technology is designed to predict and help prevent low and high glucose events, but it cannot prevent all highs and lows, and Control-IQ requires that users accurately input information, such as meals and periods of sleep or exercise. The Basal-IQ and Control-IQ features rely on continuous CGM readings and will not be able to predict glucose levels and adjust insulin dosing if your CGM is not working properly or is unable to communicate with your pump. Be sure to always use your pump, cartridges, CGM, and infusion sets as instructed and check them regularly to make sure they are working properly. Always pay attention to your symptoms, actively monitor your glucose levels, and treat according to your healthcare provider’s recommendations.

 
* As measured by CGM.
† 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.
‡ Zero fingersticks required when using the t:slim X2 pump with Dexcom G6 continuous glucose monitoring (CGM) integration. If glucose alerts and CGM readings do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions.

REFERENCES

1. Wadwa RP. Impact of Control-IQ on glycemic control for school age children with T1D. Industry Symposium. 13th International Conference on Advanced Technologies & Treatments for Diabetes, Madrid, Spain; February 20, 2020.

Important Safety Information

RX ONLY. The t:slim X2 pump, Basal-IQ technology, and Control-IQ technology are intended for single patient use. The t:slim X2 pump, Basal-IQ technology, 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 an alternate controller enabled (ACE) pump that 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 t:slim X2 pump is indicated for use in individuals six years of age and greater. Basal-IQ technology: Basal-IQ technology is intended for use with a compatible integrated continuous glucose monitor (iCGM, sold separately) and 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. Basal-IQ technology is intended for the management of diabetes mellitus in persons six years of age and greater. Control-IQ technology: Control-IQ technology is intended for use with a compatible iCGM (sold separately) and ACE pump 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 six years of age and greater.

WARNING: Control-IQ technology should not be used by anyone under the age of six 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 and Basal-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, Basal-IQ technology, and Control-IQ technology 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, alarms, and reminders. The t:slim X2 pump and the CGM transmitter and sensor must be removed before MRI, CT, or diathermy treatment. Visit tandemdiabetes.com/safetyinfo for additional important safety information.

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