Pivotal Data

Question 1

What was the insulin delivery method distribution in the pivotal study?

Answer 1

> 33% MDI, 31% insulin pump w/o automation, 35% insulin pump w/ automation

Question 2

What was the ethnic makeup of the Pivotal study?

Answer 2

74% white, 10% hispanic, 10% black, 6% mixed race

Question 3

What was the education background in the Pivotal trial?

Answer 3

35% < bachelor’s, 37% bachelors, 26% greater than bachelors

Question 4

What is the median time below 54 mg/dL for pt’s in the Pivotal trial (N=333)

<70%?

Answer 4

0.3%

1.8%

Question 5

What is the median time below 54 mg/dL for pt’s in post market study (N=2741)

<70%?

Answer 5

0.28%

1.6%