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  3. Psychosocial Impact of Control-IQ Technology in Pediatric Users

Objective

To examine the impact of Control-IQ® technology on psychosocial outcomes including sleep quality in adolescents with type 1 diabetes (T1D).

Method

We analyzed psychosocial outcomes in 14- to 17-year-old T1D adolescents who had been using Control-IQ technology on the t:slim X2™ insulin pump in a real-world setting for at least three weeks.

Results

A positive correlation was observed between participants’ emotional well-being and quality of sleep. While device-related satisfaction (DS) and quality of sleep were positively correlated, diabetes-related impact (DI) and quality of sleep were negatively correlated. DI and DS independently predicted HbA1c.

Conclusion

Quality of sleep is an important factor determining both device‑related satisfaction and quality of life in T1D adolescents.

Control-IQ Technology

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Responsible Use of Control-IQ Technology

Even with advanced systems such as the t:slim X2 insulin pump with Control-IQ technology, patients are still responsible for actively managing their diabetes. Control-IQ technology does not prevent all high and low blood glucose events. The system is designed to help reduce glucose variability, but it requires that patients accurately input information, such as meals and periods of sleep or exercise. Control-IQ technology will not function as intended unless all system components, including CGM, infusion sets and pump cartridges, are used as instructed. Importantly, the system cannot adjust insulin dosing if the pump is not receiving CGM readings. Since there are situations and emergencies that the system may not be capable of identifying or addressing, patients should always pay attention to their symptoms and treat accordingly.

* As measured by CGM.

References
1. Farabi SS. Type 1 Diabetes and Sleep. Diabetes Spectr.2016;29(1):10-13. 2. Jaser SS, Forster NC, Nelson BA, et al. Sleep in children with type 1 diabetes
2. Jaser SS, Forster NC, Nelson BA, et al. Sleep in children with type 1 diabetes and their parents in the T1D Exchange. Sleep Med. 2017;39:108-115.
3. Perez KM, Hamburger ER, Lyttle M, et al. Sleep in Type 1 Diabetes: Implications for Glycemic Control and Diabetes Management. Curr Diab Rep. 2018;18(2):5.

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 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. Control-IQ technology: Control-IQ technology is intended for use with a compatible integrated continuous glucose monitor (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 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, transmitter, and sensor must be removed before MRI, CT, or diathermy treatment. Visit www.tandemdiabetes.com/safetyinfo for additional important safety information.