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.
* chi-square test for categorical variables and Mann-Whitney U-test for continuous variables. **Relative risk and 95%confidence intervals.
Table 1: Clinical and socio-demographic characteristics according to the experience of severe and/or symptomatic hypoglycemic episodes