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About 30%-40% of Type 1 Diabetes (T1D) patients in the United States use insulin pumps. Current insulin infusion systems require users to manually input meal carb count and approve or modify the system-suggested meal insulin dose. Users can give correction insulin boluses at any time. Since meal carbohydrates and insulin are the two main driving forces of the glucose physiology, the user-specific...
We are considering the challenges that regulators face in approving modern medical devices, which are software intensive and increasingly network enabled. We then consider assurance cases, which offer the means of organizing the evidence into a coherent argument demonstrating the level of assurance provided by a system, and discuss research directions that promise to make construction and evaluation...
We discuss current trends in the development and use of high-confidence medical cyber-physical systems (MCPS). These trends, including increased reliance on software to deliver new functionality, wider use of network connectivity in MCPS, and demand for continuous patient monitoring, bring new challenges into the process of MCPS development and at the same time create new opportunities for research...
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