Table 5.
Changes in indices of disease burden
| Baseline | 6 months | 12 months | Difference (12 months) | ||
| SF-12v2 | |||||
| PCS | Observed | 50.6 (44.7 to 54.1) | 51.6 (45.9 to 54.7)** | 51.2 (45.8 to 54.7)* | |
| Number | 1360 | 1055 | 680 | ||
| Estimated | 48.8 (48.4 to 49.2) | 49.6 (49.2 to 50.1) | 49.4 (48.8 to 49.9) | 0.6 (−0.3 to 1.5) | |
| MCS | Observed | 49.6 (40.6 to 56.4) | 51.2 (43.4 to 57.8)* | 52.6 (45.1 to 58.6)* | |
| Number | 1360 | 1055 | 685 | ||
| Estimated | 48.0 (47.5 to 48.6) | 50.0 (49.4 to 50.7) | 51.3 (50.5 to 52.1) | 3.3 (2.1 to 4.4) | |
| EQ-5D-3L | |||||
| Dutch Tariff | Observed | 0.84 (0.77 to 1.00) | 0.90 (0.78 to 1.00)* | 0.90 (0.78 to 1.00)* | |
| Number | 1360 | 1056 | 685 | ||
| Estimated | 0.83 (0.82 to 0.4) | 0.86 (0.85 to 0.87) | 0.86 (0.84 to 0.87) | 0.03 (0.01 to 0.05) | |
| EQ-VAS | Observed | 72 (61 to 81) | 76 (67 to 82)* | 77 (69 to 85)* | |
| Number | 1361 | 1057 | 685 | ||
| Estimated | 68.2 (67.1 to 69.2) | 71.5 (70.3 to 72.8) | 72.6 (71.1 to 74.2) | 4.4 (2.1 to 6.7) | |
| Hypoglycemic events | |||||
| Presence of any hypoglycemic events in past 6 months, yes/no, n (%) | 1271 yes (93.5) n=1360 |
76 yes (92.4)* n=1056 |
624 yes (91.0)* n=686 |
||
| Number of hypoglycemic events in past 6 months, n (%) | Observed | 30 (10 to 72) | 30 (12 to 72) | 26 (11 to 70)* | |
| Number | 1266 | 972 | 623 | ||
| Estimated | 54.0 (50.1 to 58.0) | 54.8 (50.4 to 59.3) | 57.4 (51.9 to 63.0) | 3.4 (−4.9 to 11.7) | |
| Use of strips | |||||
| Strips per day, n (%) | Observed | 6 (4 to 8) | 5 (1 to 7)* | 3 (0 to 6)* | |
| Number | 1350 | 1049 | 685 | ||
| Estimated | 6.1 (5.9 to 6.3) | 5.0 (4.8 to 5.3) | 4.0 (3.7 to 4.3) | −2.2 (−2.6 to –1.7) | |
| Hospital admissions | |||||
| Hospital admissions in past 12 months, yes, n (%) | 187 (13.7) | 97 (7.1)** | 32 (4.7)** | ||
| Number | 1365 | 1049 | 681 | ||
| Number of hospital admissions, n | Observed | 1.0 (1.0 to 2.0) | 1.0 (1.0 to 2.5) | 1.0 (1.0 to 2.0) | |
| Number | 187 | 97 | 32 | ||
| Estimated | 0.33 (0.24 to 0.42) | 0.30 (0.19 to 0.40) | 0.09 (−0.03 to 0.22) | −0.24 (−0.43 to –0.04) | |
| Loss of working days | |||||
| Absenteeism rate in past 6 months, yes, n (%) | 251 (18.5) | 104 (9.8)* | 53 (7.7)* | ||
| Number | 1360 | 1056 | 686 | ||
| Number of working days lost in last 6 months | Observed | 7 (3 to 25) | 9 (3 to 35) | 10 (3 to 44) | |
| Number | 247 | 95 | 50 | ||
| Estimated | 34.6 (27.2 to 42.0) | 38.2 (26.5 to 50.0) | 44.4 (28.1 to 60.8) | 9.8 (−12.1 to 31.8) |
Values are presented as numbers (%), medians (25th, 75th centiles) and estimated means (difference) (95% CI). Data are presented as observed data and estimated data using the linear mixed model.
*p<0.05 as compared with baseline; **p<0.001 as compared with baseline.
EQ-5D-3L, 3-level version of EuroQol 5D; EQ-VAS, EQ-visual analogue scale; MCS, Mental Component Score; PCS, Physical Component Score; SF-12v2, 12-Item Short Form Health Surveyv2.