Introduction
Subjects and methods
Results
No SMBG | SMBG | |||||||
---|---|---|---|---|---|---|---|---|
Number of patients | Number of events | Absolute riska
| Number of patients | Number of events | Absolute riska
| Log-rank p value | HR (95%CI) | |
All patients | ||||||||
All-cause mortality | ||||||||
Model 1 (unadjusted) | 382 | 168 | 46.7 | 898 | 318 | 35.8 | 0.004 | 0.76 (0.63–0.92) |
Model 2 (adjusted)b
| 1.11 (0.92–1.35) | |||||||
Model 3 (adjusted)c
| 1.15 (0.93–1.44) | |||||||
Cardiac mortality | ||||||||
Model 1 (unadjusted) | 382 | 61 | 17.0 | 898 | 135 | 15.2 | 0.46 | 0.89 (0.66–1.21) |
Model 2 (adjusted)b
| 1.35 (0.99–1.86) | |||||||
Model 3 (adjusted)d
| 1.55 (1.07–2.24) | |||||||
Diet ± OHAs | ||||||||
All-cause mortality | ||||||||
Model 1 (unadjusted) | 354 | 145 | 42.6 | 773 | 252 | 32.5 | 0.008 | 0.76 (0.62–0.93) |
Model 2 (adjusted)b
| 1.15 (0.93–1.43) | |||||||
Model 3 (adjusted)e
| 1.20 (0.94–1.52) | |||||||
Cardiac mortality | ||||||||
Model 1 (unadjusted) | 354 | 51 | 15.0 | 773 | 108 | 13.9 | 0.65 | 0.93 (0.66–1.29) |
Model 2 (adjusted)b
| 1.51 (1.06–2.14) | |||||||
Model 3 (adjusted)f
| 1.79 (1.19–2.69) | |||||||
Insulin ± OHAs | ||||||||
All-cause mortality | ||||||||
Model 1 (unadjusted) | 28 | 23 | 119.3 | 125 | 66 | 58.4 | 0.001 | 0.46 (0.29–0.75) |
Model 2 (adjusted)b
| 0.68 (0.41–1.14) | |||||||
Model 3 (adjusted)g
| 0.73 (0.43–1.26) | |||||||
Cardiac mortality | ||||||||
Model 1 (unadjusted) | 28 | 10 | 51.9 | 125 | 27 | 23.9 | 0.026 | 0.45 (0.22–0.93) |
Model 2 (adjusted)b
| 0.58 (0.27–1.27) | |||||||
Model 3 (adjusted)h
| 0.52 (0.22–1.19) |
No SMBG at baseline | SMBG at baseline | Time-dependent SMBG use | |||||||
---|---|---|---|---|---|---|---|---|---|
No. of patients | No. of events | Absolute riska
| No. of patients | No. of events | Absolute riska
| Log-rank p value | HR (95% CI) | HR (95% CI) | |
Retinopathy | |||||||||
Model 1 (unadjusted) | 116 | 47 | 90.0 | 349 | 112 | 68.4 | 0.11 | 0.76 (0.54–1.07) | 0.51 (0.36–0.72) |
Model 2 (adjusted)b
| 0.80 (0.57–1.13) | 0.52 (0.37–0.74) | |||||||
Model 3 (adjusted)c
| 0.82 (0.58–1.16) | 0.52 (0.37–0.73) | |||||||
Neuropathy | |||||||||
Model 1 (unadjusted) | 84 | 62 | 199.3 | 256 | 186 | 203.0 | 0.76 | 1.05 (0.78–1.40) | 0.77 (0.57–1.03) |
Model 2 (adjusted)b
| 1.16 (0.87–1.55) | 0.79 (0.59–1.07) | |||||||
Model 3 (adjusted)d
| 1.30 (0.97–1.74) | 0.89 (0.66–1.20) | |||||||
Microalbuminuria | |||||||||
Model 1 (unadjusted) | 82 | 37 | 104.1 | 258 | 103 | 90.6 | 0.38 | 0.85 (0.58–1.23) | 0.77 (0.52–1.14) |
Model 2 (adjusted)b
| 0.88 (0.60–1.28) | 0.78 (0.53–1.15) | |||||||
Model 3 (adjusted)e
| 0.91 (0.62–1.33) | 0.74 (0.50–1.10) | |||||||
Any microangiopathy | |||||||||
Model 1 (unadjusted) | 58 | 50 | 280.5 | 172 | 153 | 302.6 | 0.59 | 1.09 (0.79–1.51) | 0.99 (0.71–1.38) |
Model 2 (adjusted)b
| 1.22 (0.89–1.68) | 0.96 (0.69–1.33) | |||||||
Model 3 (adjusted)f
| 1.34 (0.97–1.86) | 0.98 (0.71–1.37) | |||||||
Myocardial infarction | |||||||||
Model 1 (unadjusted) | 131 | 6 | 8.6 | 386 | 18 | 8.8 | 0.97 | 1.02 (0.41–2.57) | 0.58 (0.24–1.41) |
Model 2 (adjusted)b
| 1.13 (0.44–2.89) | 0.63 (0.26–1.54) | |||||||
Stroke | |||||||||
Model 1 (unadjusted) | 133 | 2 | 2.7 | 398 | 2 | 0.9 | 0.28 | 0.35 (0.05–2.52) | 0.19 (0.03–1.36) |
Model 2 (adjusted)b
| 0.82 (0.10–6.60) | 0.30 (0.04–2.28) | |||||||
Peripheral arterial disease | |||||||||
Model 1 (unadjusted) | 101 | 51 | 119.3 | 307 | 134 | 99.3 | 0.29 | 0.84 (0.61–1.16) | 0.74 (0.53–1.04) |
Model 2 (adjusted)b
| 0.97 (0.70–1.36) | 0.80 (0.57–1.13) | |||||||
Model 3 (adjusted)g
| 1.13 (0.79–1.62) | 0.89 (0.62–1.28) | |||||||
Any macroangiopathy | |||||||||
Model 1 (unadjusted) | 99 | 54 | 133.7 | 297 | 133 | 103.8 | 0.11 | 0.77 (0.56–1.06) | 0.67 (0.48–0.93) |
Model 2 (adjusted)b
| 0.88 (0.63–1.21) | 0.71 (0.51–0.99) | |||||||
Model 3 (adjusted)h
| 0.88 (0.63–1.22) | 0.74 (0.52–1.04) | |||||||
All vascular disease | |||||||||
Model 1 (unadjusted) | 44 | 41 | 222.0 | 141 | 128 | 230.1 | 0.95 | 0.99 (0.69–1.41) | 1.38 (0.89–2.15) |
Model 2 (adjusted)b
| 1.15 (0.80–1.64) | 1.43 (0.91–2.23) | |||||||
Model 3 (adjusted)i
| – | – | |||||||
ROSSO endpoint | |||||||||
Model 1 (unadjusted) | 110 | 8 | 13.8 | 328 | 26 | 15.3 | 0.76 | 1.13 (0.51–2.50) | 0.54 (0.26–1.14) |
Model 2 (adjusted)b
| 1.29 (0.58–2.87) | 0.58 (0.27–1.23) |