Systematic Improvement of a Bolus Calculator That Is on the Market: A User-Centric Approach.

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.