James S. Krinsley - Comment

See attached file(s) I am very excited to attend the upcoming meeting. We face a challenge that lab analyzers impose a considerable burden on nursing care as to not be useful, and, thus, the US standard of care is hand held glucose meters in hospital ICU's. Meters are not as accurate as we would like, and, though the easiest to use, nurses have a challenge of providing on time hourly measurements, which is a minimum for glycemic control. I'm hopeful that data such as that presented during the meeting plus background pre qualification data as the attached will enable FDA to approve a near continuous monitor rapidly. Safety questions aside, any clarification that FDA could provide on what is necessary for US approval will be highly welcome and needed!