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.
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Eichinger et al. (2024) studied this question.
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