| |
All |
Severe NO |
Severe YES |
p* |
RR**
(95%CI) |
Symptomatic NO |
Symptomatic YES |
p* |
RR**
(95%CI) |
| N |
2023 |
1791 |
88 |
|
|
1442 |
564 |
|
|
| Male (%) |
55.3 |
54.9 |
50.0 |
0.36 |
0.84
(0.56-1.26) |
57.4 |
50.3 |
0.004 |
0.81
(0.71-0.93) |
| Age (years) |
66.3 ± 10.2 |
66.3 ± 10.1 |
68.8 ± 10.7 |
0.01 |
- |
66.3 ± 9.9 |
66.4 ± 10.7 |
0.40 |
- |
| BMI (Kg/m2) |
29.7 ± 5.7 |
29.7 ± 5.8 |
30.4 ± 6.0 |
0.18 |
- |
29.7 ± 5.6 |
29.9 ± 6.1 |
0.90 |
- |
| Duration of diabetes (years) |
11.5 ± 8.9 |
11.3 ± 8.7 |
16.1 ± 11.7 |
0.0001 |
- |
10.6 ± 8.5 |
13.7 ± 9.4 |
<0.0001 |
- |
| HbA1c (%) |
7.1 ± 1.2 |
7.1 ± 1.2 |
7.5 ± 1.4 |
0.002 |
- |
7.1 ± 1.2 |
7.2 ± 1.1 |
0.0003 |
- |
| GFR < 60 mL/min (%) |
25.6 |
20.5 |
24.4 |
0.39 |
1.24
(0.74-1.98) |
18.9 |
25.7 |
0.001 |
1.32
(1.11-1.55) |
| Diabetes complications (%) |
|
|
|
|
|
|
|
|
|
| Cardiac/cerebrovascular |
17.8 |
17.5 |
19.3 |
0.67 |
1.12
(0.64-1.82) |
16.4 |
21.5 |
0.008 |
1.25
(1.06-1.47) |
| Lower limb complications |
8.4 |
8.0 |
10.2 |
0.46 |
1.29
(0.61-2.37) |
6.9 |
12.4 |
<0.0001 |
1.54
(1.25-1.85) |
| Retinopathy |
21.0 |
20.4 |
40.9 |
<0.0001 |
2.54
(1.67-3.82) |
16.8 |
31.6 |
<0.0001 |
1.74
(1.51-2.00) |
| Nefropathy |
18.4 |
17.9 |
25.0 |
0.09 |
1.49
(0.91-2.34) |
16.4 |
24.1 |
<0.0001 |
1.40
(1.19-1.63) |
| Sensory-motor neuropathy |
11.9 |
11.6 |
25.6 |
0.0001 |
2.46
(1.51-3.84) |
8.8 |
19.9 |
<0.0001 |
1.84
(1.56-2.14) |
| Autonomic neuropathy |
5.4 |
5.4 |
13.8 |
0.001 |
2.61
(1.38-4.44) |
3.9 |
9.0 |
<0.0001 |
1.75
(1.39-2.14) |
| Neoplasms (%) |
4.5 |
4.4 |
9.2 |
0.04 |
2.08
(0.95-3.89) |
2.0 |
3.2 |
0.11 |
1.23
(0.89-1.61) |
| Glucose lowering pharmacologic treatments (%) |
|
|
|
|
|
|
|
|
|
| Metformin |
60.5 |
61.0 |
48.9 |
0.02 |
0.63
(0.42-0.94) |
63.3 |
53.7 |
<0.0001 |
0.75
(0.66-0.87) |
| Sulphanylureas |
21.0 |
20.9 |
18.2 |
0.53 |
0.85
(0.48-1.40) |
21.4 |
20.0 |
0.51 |
0.94
(0.79-1.12) |
| Glinides |
12.0 |
12.0 |
13.6 |
0.63 |
1.15
(0.61-2.00) |
10.8 |
15.3 |
0.006 |
1.31
(1.08-1.57) |
| Acarbose |
4.2 |
4.0 |
3.4 |
0.79 |
0.86
(0.21-2.22) |
4.3 |
3.9 |
0.69 |
0.93
(0.62-1.30) |
| Glitazones |
5.4 |
5.1 |
5.7 |
0.82 |
1.11
(0.40-2.39) |
5.9 |
4.1 |
0.11 |
0.75
(0.50-1.05) |
| DPP-IV inhibitors |
16.7 |
17.2 |
9.1 |
0.05 |
0.49
(0.22-0.95) |
17.6 |
14.9 |
0.15 |
0.87
(0.70-1.05) |
| GLP-1 receptor agonists |
4.8 |
4.8 |
8.0 |
0.17 |
1.68
(0.72-3.26) |
5.3 |
3.9 |
0.20 |
0.79
(0.52-1.11) |
| Human regular insulin |
0.4 |
0.4 |
0.0 |
0.56 |
0.00
(0.00-0.00) |
0.4 |
0.4 |
0.98 |
1.02
(0.19-2.32) |
| Short-acting insulin analogues |
21.6 |
20.4 |
52.3 |
<0.0001 |
3.90
(2.60-5.86) |
14.4 |
39.9 |
<0.0001 |
2.42
(2.12-2.76) |
| Basal insulin analogues |
25.4 |
24.2 |
51.1 |
<0.0001 |
3.06
(2.04-4.60) |
19.3 |
40.9 |
<0.0001 |
2.03
(1.77-2.32) |
| Premix insulin |
4.2 |
4.3 |
8.0 |
0.11 |
1.85
(0.79-3.58) |
3.1 |
7.1 |
<0.0001 |
1.75
(1.35-2.17) |
| Glucose lowering therapy schemes (%) |
|
|
|
<0.0001 |
|
|
|
<0.0001 |
|
| OHA (combination with secretagogues) |
33.5 |
34.1 |
15.9 |
|
1.00 |
38.4 |
20.7 |
|
1.00 |
| OHA (combination without secretagogues) |
26.4 |
26.4 |
22.7 |
|
1.81
(0.93-3.63) |
25.9 |
28.0 |
|
1.70
(1.38-2.11) |
| Insulin (basal oral) |
6.7 |
6.6 |
8.0 |
|
2.48
(0.96-5.83) |
6.6 |
6.9 |
|
1.65
(1.19-2.23) |
| Insulin (basal bolus) |
15.6 |
14.5 |
40.9 |
|
5.45
(3.06-10.30) |
10.5 |
28.6 |
|
2.95
(2.43-3.60) |
| Insulin (Other schemes) |
7.9 |
8.0 |
12.5 |
|
3.21
(1.45-6.92) |
5.8 |
12.9 |
|
2.68
(2.11-3.38) |
| Diet |
10.0 |
10.5 |
0 |
|
- |
12.8 |
2.8 |
|
- |
| SMBG (%) |
86.9 |
86.3 |
99.0 |
<0.001 |
13.10
(2.94-230.38) |
83.8 |
95.2 |
<0.0001 |
2.96
(2.10-4.37) |
| Number of drugs other than glucose lowering ones |
3.3 ± 2.6 |
3.3 ± 2.6 |
3.8 ± 2.7 |
0.03 |
|
3.1 ± 2.6 |
3.7 ± 2.7 |
<0.0001 |
- |
| Antihypertensive treatments (%) |
70.7 |
70.5 |
70.4 |
0.99 |
1.00
(0.65-1.59) |
70.6 |
71.9 |
0.55 |
1.05
(0.90-1.23) |
| ACE-Inhibitors (%) |
29.1 |
29.3 |
28.4 |
0.86 |
0.96
(0.60-1.49) |
28.5 |
31.0 |
0.26 |
1.09
(0.94-1.26) |
| Beta-blockers (%) |
24.6 |
24.1 |
33.0 |
0.06 |
1.51
(0.97-2.31) |
23.9 |
26.8 |
0.17 |
1.12
(0.95-1.30) |
| Lipid-lowering treatments (%) |
56.4 |
56.8 |
56.8 |
1.00 |
1.00
(0.66-1.52) |
55.6 |
59.1 |
0.16 |
1.11
(0.96-1.28) |
| Employment status (%): |
|
|
|
0.63 |
|
|
|
0.94 |
|
| Employed |
20.9 |
20.6 |
18.8 |
|
1.00 |
21.1 |
20.5 |
|
1.00 |
| Unemployed |
19.1 |
19.7 |
16.5 |
|
1.09
(0.54-2.23) |
18.9 |
19.4 |
|
0.96
(0.77-1.20) |
| Retired |
60.1 |
59.7 |
64.7 |
|
1.28
(0.75-2.37) |
60.1 |
60.1 |
|
0.98
(0.82-1.18) |
| Highest level of school education (%): |
|
|
|
0.11 |
|
|
|
0.20 |
|
| Primary school |
40.3 |
40.3 |
52.3 |
|
1.00 |
39.2 |
43.6 |
|
1.00 |
| Middle school |
30.6 |
30.3 |
28.4 |
|
0.73
(0.45-1.17) |
31.7 |
27.5 |
|
0.84
(0.70-0.99) |
| High school |
22.8 |
23.3 |
14.8 |
|
0.50
(0.26-0.89) |
22.9 |
22.1 |
|
0.90
(0.75-1.08) |
| University |
6.3 |
6.1 |
4.6 |
|
0.59
(0.18-1.42) |
6.1 |
6.8 |
|
1.00
(0.73-1.30) |
| Living status (%): |
|
|
|
0.89 |
|
|
|
0.49 |
|
| Spouse/sons |
77.8 |
78.0 |
76.1 |
|
1.00 |
78.6 |
75.5 |
|
1.00 |
| Alone |
15.8 |
15.7 |
18.2 |
|
1.18
(0.67-1.95) |
15.4 |
17.2 |
|
1.11
(0.92-1.33) |
| Other family members |
4.3 |
4.5 |
3.4 |
|
0.79
(0.20-2.07) |
4.1 |
5.1 |
|
1.21
(0.86-1.61) |
| Other |
2.1 |
1.9 |
2.3 |
|
1.20
(0.20-3.62) |
2.0 |
2.1 |
|
1.06
(0.61-1.62) |
| Marital status (%): |
|
|
|
0.65 |
|
|
|
0.08 |
|
| Not married |
7.4 |
7.3 |
4.6 |
|
1.00 |
7.4 |
7.2 |
|
1.00 |
| Married/cohabitant |
75.2 |
75.5 |
78.4 |
|
1.64
(0.69-5.32) |
76.5 |
71.9 |
|
0.98
(0.76-1.32) |
| Separated/divorced |
4.3 |
4.2 |
5.7 |
|
2.12
(0.58-8.35) |
3.9 |
5.4 |
|
1.27
(0.85-1.88) |
| Widower |
13.1 |
13.0 |
11.4 |
|
1.38
(0.47-4.97) |
12.1 |
15.6 |
|
1.22
(0.90-1.69) |
| Taking care of other people (%) |
37.3 |
37.2 |
29.6 |
0.15 |
0.72
(0.45-1.11) |
36.1 |
40.0 |
0.11 |
1.12
(0.97-1.30) |
| Previous experience of severe hypoglycemia (before the last 12 months) (%) |
10.0 |
9.1 |
36.4 |
<0.0001 |
4.93
(3.24-7.37) |
6.3 |
19.3 |
<0.0001 |
2.16
(1.85-2.50) |
Data are expressed as means and their standard deviations or frequencies.