AI Article Synopsis
- State-of-the-art diabetes self-management tools, like Bolus Calculators, require ongoing evaluation for safety and effectiveness even after they hit the market, beyond what's possible in clinical trials.
- The study uses innovative methods such as human factor engineering and real-world data analysis to gather user-centric evidence to improve the bolus calculator.
- The results show a significant decrease in hypoglycemic events, higher patient satisfaction with diabetes treatment, and increased acceptance of bolus calculations, highlighting the need for continuous product improvement.
Article Abstract
Background: State-of-the-art diabetes self-management includes the usage of (software) tools, such as Bolus Calculators, to support patients with their therapeutic decisions. The development of such medical devices comes with strict obligations to ensure the safety and performance for the user; however, it is also necessary to continue to evaluate such aspects after the products are introduced into the market. In addition, such aspects cannot always be sufficiently validated by clinical trials; they need real-world evaluation to systematically improve such tools while they are on the market.
Methods: The approach described here uses innovative ways of generating user-centric evidence to improve the bolus calculator, including (1) human factor engineering, (2) analysis of glycemic real-world data, (3) patient-reported outcomes, and (4) machine-generated behavioral measurements.
Results: The combination of the diverse techniques to optimize the bolus calculator triggered changes in the user experience: a significant reduction in hypoglycemic events, -0.52% (±0.05), < .01, n=3480, an increased diabetes treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire [DTSQ] +9.90, < .01, n=217), as well as an increased acceptance rate of bolus calculations, +15.73 (±0.89), < .01, n=3436, were observed.
Conclusions: Altogether, human factor engineering and different forms of real-world data support fast and direct adaptations and improvements in products used for diabetes therapy.
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Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11572182 | PMC |
| http://dx.doi.org/10.1177/19322968241266204 | DOI Listing |
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