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.

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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, users 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 users 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, users 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

The t:slim X2 insulin pump with Control-IQ technology (the 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 System. 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. The pump and the System are intended for single user use. The pump and the System are indicated for use with NovoRapid, Admelog, or Humalog U-100 insulin. The System is intended for the management of Type 1 diabetes.

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 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; 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.