Background
Methods
Study design
Clinical endpoints
HRQoL measurement
Statistical analyses
Results
Demographics and characteristics of respondents
Insulin experienced N = 1966 | Insulin naïve N = 6612 | Total cohort N = 8578 | ||
---|---|---|---|---|
Gender | Male, % | 1104 (56.2) | 3786 (57.3) | 4890 (57.0) |
Age | Years, mean (sd) | 56.7 (15.2) | 54.3 (14.2) | 54.9 (14.4) |
Weight | Kg, mean (sd) | 68.2 (11.2) | 68.1 (11.6) | 68.1 (11.5) |
BMI | Kg/m2, mean (sd) | 24.8 (3.3) | 24.6 (3.3) | 24.7 (3.3) |
Duration of diabetes | Years, mean (sd) | 9.3 (6.8) | 5.0 (5.4) | 6.0 (6.0) |
Clinical endpoints
Insulin-experienced, N = 1,966 | Insulin-naïve, N = 6,612 | Total cohort, N = 8,578 | ||
---|---|---|---|---|
HbA1c (%) | N | 1056 | 3386 | 4442 |
Baseline | 9.1 (2.3) | 9.6 (2.2) | 9.5 (2.3) | |
Week 24 | 7.0 (1.1) | 7.0 (1.0) | 7.0 (1.0) | |
Change | -2.0 (2.2) | -2.7 (2.2) | -2.5 (2.2) | |
P value | <0.001 | <0.001 | <0.001 | |
Body weight (kg) | N | 1459 | 4600 | 6059 |
Baseline | 68.7 (11.2) | 68.5 (11.3) | 68.5 (11.3) | |
Week 24 | 69.2 (10.9) | 68.8 (10.8) | 68.9 (10.8) | |
Change | 0.5 (3.0) | 0.3 (3.1) | 0.3 (3.1) | |
P value | <0.001 | <0.001 | <0.001 | |
Overall hypoglycaemia (events/patient year) | N | 1966 | 6612 | 8578 |
Baseline | 6.12 | 1.2 | 2.32 | |
Week 24 | 2.14 | 1.37 | 1.54 | |
Nocturnal hypoglycaemia (events/patient year) | N | 1966 | 6612 | 8578 |
Baseline | 1.65 | 0.26 | 0.58 | |
Week 24 | 0.42 | 0.24 | 0.28 | |
Major hypoglycaemia (events/patient year) | N | 1966 | 6612 | 8578 |
Baseline | 0.37 | 0.09 | 0.15 | |
Week 24 | 0.00 | 0.00 | 0.00 | |
Minor hypoglycaemia (events/patient year) | N | 1966 | 6612 | 8578 |
Baseline | 5.75 | 1.10 | 2.17 | |
Week 24 | 2.14 | 1.37 | 1.54 |
Quality of life
Quality of life in the total cohort
Insulin-experienced, N = 1,966 | Insulin-naïve, N = 6,612 | Total cohort, N = 8,578 | ||
---|---|---|---|---|
EQ-5D VAS (Scale 0-100) | N | 1390 | 4713 | 6103 |
Baseline | 75.3 (14.1) | 75.9 (13.4) | 75.8 (13.6) | |
Week 24 | 82.0 (11.3) | 82.0 (10.3) | 82.0 (10.6) | |
Change | 6.7 (15.8) | 6.1 (14.4) | 6.2 (14.7) | |
P value | <0.001 | <0.001 | <0.001 | |
QoL UK (Scale 0-1) | N | 1406 | 4814 | 6220 |
Baseline | 0.851 (0.190) | 0.882 (0.176) | 0.875 (0.179) | |
Week 24 | 0.886 (0.170) | 0.896 (0.157) | 0.893 (0.160) | |
Change | 0.035 (0.228) | 0.014 (0.218) | 0.018 (0.221) | |
P value | <0.001 | <0.001 | <0.001 | |
Mobility dimension | N | 1416 | 4843 | 6259 |
No problems with walking (%) | Baseline | 1197 (84.5) | 4333 (89.5) | 5530 (88.4) |
Week 24 | 1289 (91.0) | 4433 (91.5) | 5722 (91.4) | |
P value | <0.0001 | 0.0005 | <0.0001 | |
Self-care dimension | N | 1415 | 4845 | 6260 |
No problems with self-care (%) | Baseline | 1301 (91.9) | 4475 (92.4) | 5776 (92.3) |
Week 24 | 1280 (90.5) | 4483 (92.5) | 5763 (92.1) | |
P value | 0.1635 | 0.7584 | 0.6655 | |
Usual activities dimension | N | 1415 | 4841 | 6256 |
No problems with performing usual activities (%) | Baseline | 1222 (86.4) | 4316 (89.2) | 5538 (88.5) |
Week 24 | 1236 (87.3) | 4272 (88.2) | 5508 (88.0) | |
P value | 0.4361 | 0.1578 | 0.4043 | |
Pain/discomfort dimension | N | 1411 | 4832 | 6243 |
No pain or discomfort (%) | Baseline | 1007 (71.4) | 3820 (79.1) | 4827 (77.3) |
Week 24 | 1138 (80.7) | 4031 (83.4) | 5169 (82.8) | |
P value | <0.0001 | <0.0001 | <0.0001 | |
Anxiety/depression dimension | N | 1413 | 4837 | 6250 |
Not anxious or depressed (%) | Baseline | 1014 (71.8) | 3624 (74.9) | 4638 (74.2) |
Week 24 | 1067 (75.5) | 3749 (77.5) | 4816 (77.1) | |
P value | 0.0236 | 0.0028 | 0.0002 |
Quality of life for prior insulin-experienced and insulin-naïve subgroups
Linear OLS regression for the change in EQ-5D score
Variables | Coefficient | P-value |
---|---|---|
Intercept | 5.4377 | 0.1041 |
Macro-complications (yes = 1, no = 0) | -0.6064 | 0.3188 |
Micro-complications (yes = 1, no = 0) | 1.4226 | 0.0067 |
Duration of diabetes | 0.02993 | 0.5239 |
Age | 0.02403 | 0.2699 |
Male | -0.839 | 0.0944 |
BMI at baseline | -0.1454 | 0.0554 |
Pre_study treatment (Insulin naïve = 1, insulin users = 0) | -0.5474 | 0.3547 |
HbA1c at baseline | 0.3459 | 0.0013 |
SBP at baseline | 0.0208 | 0.1661 |
Total cholesterol at baseline | 0.4528 | 0.0817 |
HDL at baseline | -2.3537 | <.001 |
LDL at baseline | -0.7543 | 0.0138 |
Total hypoglycaemia at baseline (yes = 1, no = 0) | 0.01457 | 0.9628 |
Major hypoglycaemia at baseline (yes = 1, no = 0) | 6.957 | <.001 |