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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 842-850 |
| Number of pages | 9 |
| Journal | Diabetes Technology and Therapeutics |
| Volume | 26 |
| Issue number | 11 |
| DOIs | |
| State | Published - Nov 1 2024 |
Funding
Thank you to Steven Russell, MD, PhD, Ed Damiano, PhD, the Bionic Pancreas Research Group, and the JAEB Center For Health Research for providing the data for the present study, which were collected during the pivotal trial on the iLet bionic pancreas. The authors thank Lawrence Fisher PhD, ABPP, and William Polonsky, PhD, CDCES, for assisting with the development of initial measure content and item wording. Thank you to Juan Espinoza Salomon, MD, for supporting glucose summary metric analyses. The authors also thank the participants for their time and effort, the diabetes care providers who referred potential participants to the study staff, and the multicenter research study staff. This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (grant number 1UC4DK108612-01), by an Investigator-Initiated Study award from Novo Nordisk, and by Beta Bionics, Inc. Supplies were provided by Beta Bionics, Inc. (bionic pancreas), Novo Nordisk (fast-acting insulin aspart, insulin aspart), Eli Lilly (insulin lispro), Ascensia Diabetes Care (blood glucose meters and test strips), and Dexcom, Inc (continuous glucose monitor sensors and transmitters purchased at a discounted price). This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (grant number 1UC4DK108612\u201301 ), by an Investigator-Initiated Study award from Novo Nordisk , and by Beta Bionics, Inc. Supplies were provided by Beta Bionics, Inc. (bionic pancreas), Novo Nordisk (fast-acting insulin aspart, insulin aspart), Eli Lilly (insulin lispro), Ascensia Diabetes Care (blood glucose meters and test strips), and Dexcom, Inc (continuous glucose monitor sensors and transmitters purchased at a discounted price).
Keywords
- artificial pancreas
- automated insulin delivery
- bionic pancreas
- closed-loop systems
- patient reported outcomes
- psychosocial
- type 1 diabetes
ASJC Scopus subject areas
- Endocrinology, Diabetes and Metabolism
- Endocrinology
- Medical Laboratory Technology
