Basal-IQ Technology Real-World Psychosocial Outcomes

Objective

To better understand the formation of trust in automated insulin delivery (AID) systems by examining the relationship between trust and psychosocial outcomes and AID system usability.

Method

Individuals with diabetes responded to an online survey administered by dQ&A, which assessed variables of interest, trust, AID system perceived usability, psychosocial outcomes, basic demographics, and information on method of diabetes management.

Results

Hierarchical multiple regression analysis was used to ascertain the significance of ease of use (device level) and psychosocial (individual level) predictors of trust in AID systems. There were no issues with multicollinearity (all VIFs < 3). Ease of use accounted for 45% of variance in trust, F (3,382) = 106.74, p < .001. After psychosocial predictors were added variance accounted for was 64%, explaining an additional 19% of unique variance in trust, F (3,379) = 65.46, p < .001. Specifically the predictor variables (i.e., easy to use, too complicated, satisfaction, helps me have good BG control, and helps me sleep better at night) all significantly predict trust in AID systems.

Conclusion

Study findings suggest that both AID system perceived usability and psychosocial outcomes are distinctly informative and instrumental in the development of trust in AID systems.

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Hierachical Regression Results

Variance in Trust

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Product Training

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Responsible Use of Basal-IQ Technology

Systems like the t:slim X2 insulin pump with Basal-IQ technology are not substitutes for the active management of diabetes. There are common scenarios in which automated systems cannot prevent a hypoglycemic event. The Basal-IQ feature relies on current CGM sensor readings to function and will not be able to predict glucose levels and suspend insulin delivery if the user’s CGM is not functioning properly or his/her pump is unable to receive the CGM signal. It’s recommended the user always uses the components of the pump system (pump, cartridges, CGM, and infusion sets) according to the applicable instructions for use and checks them regularly to make sure they are functioning as expected. Users should always pay attention to their symptoms, actively monitor and manage glucose levels, and treat according to your recommendations.

* Tandem Diabetes Care, Inc. † dQ&A

Important Safety Information

The t:slim X2 insulin pump with Basal-IQ technology (the System) consists of the t:slim X2 insulin pump, which contains Basal-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 suspend insulin delivery based on CGM sensor readings. 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 not indicated for use in pregnant women, people on dialysis, or critically ill users. 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. 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.