| |
Patients who remained insulin-naïve
|
Patients switched to insulin treatment
|
Patients who remained on insulin therapy
|
p between groups
|
|---|
|
HbA1c (%)
|
|
Baseline
|
8.3 (± 1.4)
|
9.1 (± 1.7)
|
8.6 (± 1.7)
|
.078
|
|
Endpoint
|
6.7 (± 0.8)
|
7.1 (± 1.1)
|
7.7 (± 1.2)
|
< .001c
|
|
Change
|
-1.6 (± 1.7)*
|
-1.8 (± 1.8)*
|
-0.9 (± 1.7)*
|
< .0011bc
|
|
BMI (kg/m2)
|
|
Baseline
|
32.9 (± 6.5)
|
32.4 (± 5.8)
|
35.7 (± 7.9)
|
.051
|
|
Endpoint
|
31.2 (± 6.6)
|
31.3 (± 5.2)
|
35.0 (± 7.9)
|
.010bc
|
|
Change
|
-1.7 (± 1.5)*
|
-1.1 (± 1.9)*
|
-0.7 (± 2.6)*
|
.0541
|
|
ITAS (total score)
|
|
Baseline
|
51.2 (± 12.2)
|
49.2 (± 9.8)
|
45.8 (± 8.3)
|
.040 c
|
|
Endpoint
|
53.6 (± 12.3)
|
46.2 (± 9.9)
|
44.5 (± 8.0)
|
< .001bc
|
|
Change
|
2.4 (± 14.8)ns
|
-3.0 (± 7.0)*
|
-1.3 (± 8.0) ns
|
.0031ac
|
|
Negative ITAS
|
|
Baseline
|
41.8 (± 12.2)
|
41.0 (± 9.1)
|
37.4 (± 10.4)
|
.063
|
|
Endpoint
|
43.4 (± 11.8)
|
37.9 (± 8.7)
|
35.7 (± 7.4)
|
.002bc
|
|
Change
|
1.6 (± 15.0) ns
|
-3.1 (± 6.5)*
|
-1.7 (± 7.3) ns
|
.0061ac
|
|
Positive ITAS
|
|
Baseline
|
10.4 (± 2.5)
|
9.5 (± 2.2)
|
9.4 (± 1.9)
|
.098
|
|
Endpoint
|
11.0 (± 2.8)
|
9.4 (± 2.2)
|
9.6 (± 2.0)
|
.008bc
|
|
Change
|
0.6 (± 3.0) ns
|
-0.1 (± 2.2) ns
|
0.2 (± 2.4) ns
|
.0421ac
|
|
PAID
|
|
Baseline
|
27.7 (± 17.8)
|
33.8 (± 18.4)
|
28.2 (± 14.1)
|
.166
|
|
Endpoint
|
21.8 (± 13.9)
|
26.5 (± 15.6)
|
24.6 (± 16.9)
|
.384
|
|
Change
|
-5.9 (± 15.8) ns
|
-7.3 (± 14.9) *
|
-3.6 (± 15.1) ns
|
.2851
|
|
WHO-5
|
|
Baseline
|
16.4 (± 6.0)
|
13.6 (± 6.3)
|
12.9 (± 6.4)
|
.056
|
|
Endpoint
|
16.7 (± 5.6)
|
15.6 (± 5.8)
|
13.9 (± 6.0)
|
.129
|
|
Change
|
0.3 (± 5.7) ns
|
2.0 (± 4.9) *
|
1.0 (± 5.7) ns
|
.3891
|
|
CES-D
|
|
Baseline
|
11.7 (± 8.2)
|
16.1 (± 10.2)
|
17.8 (± 10.9)
|
.039c
|
|
Endpoint
|
10.8 (± 7.9)
|
11.9 (± 9.8)
|
16.4 (± 9.8)
|
.019
|
|
Change
|
-0.9 (± 7.1) ns
|
-4.2 (± 6.0) *
|
-1.4 (± 8.5) ns
|
.0451b
|
|
Trait Anxiety
|
|
Baseline
|
37.7 (± 9.7)
|
41.3 (± 12.0)
|
41.6 (± 8.4)
|
.227
|
|
Endpoint
|
36.4 (± 8.3)
|
40.2 (± 10.6)
|
40.7 (± 9.9)
|
.138
|
|
Change
|
-1.3 (± 5.9) ns
|
-1.1 (± 8.2) ns
|
-0.9 (± 7.2) ns
|
.6221
|
- Values are means (± SD); 1 adjusted for baseline; a = p < .05 between "patients who remained insulin-naïve" and "patients switched to insulin treatment"; b = p < .05 between "patients switched to insulin treatment" and "patients who remained on insulin therapy"; c = p < .05 between "patients who remained insulin-naïve" and "patients who remained on insulin therapy"; * significant within comparison (p < .05), ns non-significant within comparison (p > .05)
