Tandem t:slim X2 User Manual page 311

DCLP3: Change in HbA1c Values from Randomization to 26 Weeks (N=168) (Continued)
Treatment
HbA1c ≥ 10%
Control
Treatment
Overall
Control
DCLP5: Change in HbA1c Values from Randomization to 16 Weeks (N=101)
Baseline Central Lab
HbA1c
Treatment
5% ≤ HbA1c < 6%
Control
Treatment
6% ≤ HbA1c < 7%
Control
Treatment
7% ≤ HbA1c < 8%
Control
CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies
Number of Subjects (% of Subjects) with Change in HbA1c
2 2 100% 0
0 0 0% 0
111 12 11% 69
55 0 0% 29
Number of Subjects (% of Subjects) with Change in HbA1c
Decrease Decrease
>1% 0 to 1%
n % n
n
3 0 0% 0
0 0 0% 0
18 0 0% 9
3 0 0% 1
28 3 11% 20
8 0 0% 5
0% 0 0% 0
0% 0 0% 0
62% 6 5% 23
53% 1 2% 22
Increase
No Change
0 to 1%
% n % n
0% 2 67% 1
0% 0 0% 0
50% 1 6% 8
33% 0 0% 2
71% 0 0% 5
63% 0 0% 2
0% 0 0%
0% 0 0%
21% 1 <1%
40% 3 5%
Increase
>1%
% n %
33% 0 0%
0% 0 %0
44% 0 0%
67% 0 0%
18% 0 0%
25% 1 13%
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