Table 1.
Description of baseline population characteristics and changes in clinical and HRQoL outcomes during the study period
| Baseline | 3 months | 6 months | |
|---|---|---|---|
| Demographics | |||
| N | 447 | ||
| Age | 59 ± 11 | ||
| Male/female | 227/220 | ||
| Diabetes duration (years) | 11 (7,16) | ||
| N, % lower educated | 223 (50%) | ||
| BMI (kg/m2) | 31.6 ± 6.8 | 32.0 ± 6.9* | 32.0 ± 6.8** |
| Number of complications | 1 (0, 2) | ||
| Number of comorbidities | 1 (0, 2) | ||
| HbA1c (%) | 8.8 ± 1.4 | 8.0 ± 1.2** | 7.7 ± 1.3** |
| FBG (mmol/l) | 10.2 ± 3.7 | 8.5 ± 2.8** | 8.4 ± 2.9** |
| Hypoglycaemic episodes during the past three months | |||
| Symptomatic | 3 (0, 7) | 0 (2, 6)* | 0 (2, 6) |
| N, % 1 or more | 330 (74%) | 304 (68%) | 298 (67%)* |
| Nocturnal | 0 (0, 2) | 0 (0, 1)* | 0 (0, 0)* |
| N, % 1 or more | 174 (39%) | 131 (29%)* | 108 (24%)* |
| Severe | 0.2 ± 0.5 | 0.2 ± 0.5 | 0.1 ± 0.5 |
| N, % 1 or more | 48 (11%) | 55 (12%) | 41 (9%) |
| Insulin | |||
| IU NPHa | 30 (22, 46) | ||
| IU mixa | 62 (38, 88) | ||
| IU levemira | 38 (24, 60) | ||
| IU rapid acting (54.5 ± 34.3a) | 48 (32, 72) | 52 ± 36 | 51 ± 37 |
| IU glargine | 42 (26, 60) | 48 (26, 68) | 42 (26, 70) |
| HRQoL outcome measures | |||
| DSC-r | 14 (6, 26) | 11 (4, 21)** | 10 (4, 20)** |
| DSC-r sub-domains | |||
| Hyperglycemia | 13 (6, 31) | 6 (0, 19)** | 6 (0, 19)* |
| Hypoglycemia | 8 (0, 25) | 8 (0, 25)** | 8 (0, 17)* |
| Cognitive | 13 (0, 31) | 6 (0, 25)* | 6 (0, 25)** |
| Fatigue | 25 (6, 50) | 19 (6, 44)** | 19 (0, 38)** |
| Cardiovascular | 6 (0, 19) | 6 (0, 19)* | 6 (0, 13)* |
| Neuropathic sensory | 8 (0, 25) | 4 (0, 17)* | 4 (0, 21)* |
| Neuropathic pain | 6 (0, 19) | 6 (0, 19) | 6 (0, 25) |
| Vision | 5 (0, 20) | 5 (0, 10)** | 0 (0, 10)** |
| HFS-w | 15 (4, 27) | 12 (4, 29) | 13 (4, 35) |
| WHO-5 | 56 ± 23 | 62 ± 23** | 65 ± 22** |
Mean ± SD’s are presented for variables with a normal distribution. Median (25th percentile, 75th percentile) are presented for variables with a right-skewed distribution. P values are corrected for age, education level, diabetes duration, BMI, the number of diabetes-related complaints, the number of symptomatic, nocturnal and severe hypoglycemic episodes during the past month. BMI body mass index, FBG fasting blood glucose, IU insulin units, HbA1c glycosylated haemoglobin, DSC-r diabetes symptom checklist revised, HFS-w hypoglycaemia fear survey-worry sub-scale, WHO-5 world health organisation five well-being index
aPre-glargine treatment
*P with baseline < 0.05
**P with baseline < 0.001