Psychometric Properties of the Automated Insulin Delivery: Benefits and Burdens Scale for Adults with Type 1 Diabetes.

Abstract

Objective: To evaluate the psychometric properties of a patient-reported outcome measure, the Automated Insulin Delivery-Benefits and Burdens Scale (AID-BBS), which was designed to assess benefits and burdens of AID use in adults with type 1 diabetes (T1D). The measure was hypothesized to have validity, reliability, and clinical utility for predicting likelihood of continued use of an AID system. Research Design and Methods: A total of 217 adults with T1D (ages from 18 to 82 years) who were enrolled in an AID system research trial completed AID-BBS items at study midpoint (6 weeks) and at the end of the trial (13 weeks). Data were collected on pre-post glycemic outcomes. Participants completed other patient-reported psychosocial outcome measures (e.g., emotional well-being, diabetes distress, attitudes toward diabetes technology, diabetes treatment satisfaction) at Week 13. Likelihood of continued device use was assessed with three items at 13 weeks. Results: Exploratory factor analysis supported a one-factor structure for each subscale (15-item benefit and 9-item burden subscale) when evaluated separately. Convergent, discriminant, and predictive validity, internal consistency, and test-retest reliability were supported. Benefit and burden subscales at week 6 predicted usage intention above and beyond device impact on glycemic outcomes, also controlling for baseline glycemic outcomes. Conclusion: Findings support the AID-BBS as a psychometrically valid, reliable, and useful instrument for assessing burdens and benefits associated with AID system use in adults with T1D. The measure can be used to help health care providers set realistic expectations and proactively address modifiable burdens. Clinical Trial Registration Number: NCT04200313.