Table 1.
Demographics of the study population and changes in clinical outcomes and QoL during the period of study
| Demographics | Baseline | 3 months | 6 months |
|---|---|---|---|
| N | 911 | ||
| Gender | |||
| Men | 479 (52.5%) | ||
| Women | 432 (47.5%) | ||
| Age (years) | 62.15 ± 10.92 | ||
| Level of education | |||
| Low | 626 (68.7%) | ||
| Average | 188 (20.7%) | ||
| High | 97 (10.7%) | ||
| Diabetes duration (years) | 6.00 (3.00–9.00) | ||
| HbA1c (mmol/mol)a | |||
| Mean ± SD | 72 ± 17 | 61 ± 11 | 57 ± 11 |
| Median (25th–75th) | 67 (61–77) | 60 (53–67) | 56 (50–63) |
| HbA1c (%)a | |||
| Mean ± SD | 8.7 ± 1.5 | 7.7 ± 1.0 | 7.4 ± 1.0 |
| Median (25th–75th) | 8.3 (7.7–9.2) | 7.6 (7.0–8.3) | 7.3 (6.7–7.9) |
| Symptomatic hypoglycaemiab | |||
| 0 episodes | 572 (62.8%) | 524 (57.6%) | 514 (56.5%) |
| 1, 2 or 3 episodes | 163 (17.9%) | 211 (23.2%) | 232 (25.4%) |
| 4 or more episodes | 176 (19.3%) | 176 (19.3%) | 165 (18.1%) |
| Nocturnal hypoglycaemiab | |||
| 0 episodes | 783 (86.0%) | 781 (85.8%) | 745 (81.8%) |
| 1 or 2 episodes | 62 (6.8%) | 85 (9.4%) | 110 (12.1%) |
| 3 or more episodes | 66 (7.2%) | 45 (4.9%) | 56 (6.1%) |
| Severe hypoglycaemiab | |||
| 0 episodes | 882 (96.8%) | 872 (95.7%) | 860 (94.3%) |
| 1 episode | 14 (1.5%) | 28 (3.1%) | 27 (3.0%) |
| 2 episodes | 15 (1.6%) | 11 (1.2%) | 24 (2.6%) |
| Previous treatmentc | |||
| SU-derivate | 697 | ||
| Other | 743 | ||
| Body mass index (BMI) | 30.09 ± 5.85 | 30.17 ± 5.80 | 30.51 ± 5.76 |
| Complications | |||
| 0 | 648 (71.1%) | ||
| 1 or more | 263 (28.9%) | ||
| Complicationsd | |||
| Nephropathy | 21 (2.3%) | ||
| Neuropathy | 86 (9.4%) | ||
| Retinopathy | 42 (4.6%) | ||
| Macroalbuminuria | 26 (2.9%) | ||
| Macroangiopathy | 64 (7.0%) | ||
| Microalbuminuria | 110 (12.1%) | ||
| WHO-5e | 56.71 (25.52) | 63.33 (21.22) | 65.27 (20.52) |
| HFS-wf | 7.69 (1.92–21.15) | 5.77 (0.00–15.38) | 3.85 (0.00–15.38) |
| DSC-rg | 11.71 (4.71–22.14) | 8.07 (3.13–17.14) | 8.09 (2.88–16.04) |
For dichotomous or categorical variables the absolute numbers by subgroups and the percentage compared to the overall study population are displayed. For normally distributed variables the mean and standard deviation are shown. For skewed variables the median and the 25th and 75th percentile are shown
aAt baseline HbA1c was skewed distributed, but normally distributed at 3 and 6 months
bNumber of episodes during 3 months prior to visit
cOne case may use multiple oral agents
dOne case may have multiple complications
eMeasured as emotional well-being experienced during 2 weeks prior to visit
fMeasured as hypoglycaemia fear experienced during 3 months prior to visit
gMeasured as diabetes symptom distress experienced during month prior to visit