Observational Study
Copyright ©2014 Baishideng Publishing Group Inc.
World J Diabetes. Aug 15, 2014; 5(4): 569-576
Published online Aug 15, 2014. doi: 10.4239/wjd.v5.i4.569
Table 1 Baseline characteristics (including health-related quality of life parameters) for all patients included and for patients who did an did not completed long term follow-up, categorized per treatment modality
Clinical characteristicsAll enrolled patientsPatients completed follow- up until 2002 (A)whoPatients completed follow- up until 2010 (B)whoPatients who completed follow- up until 2010 (C)did notMDIFrom MDI to CSIICSIIP-valueP-value
(n = 281)(n = 201)(n = 113)(n = 168)(n = 52)(n = 33)(n = 28)(A vs B)(B vs C)
Age (yr)37.2 (28.5, 45.0)36.7 (29.0, 43.4)37.1 (29.4, 43.0)37.1 (27.4, 45.8)37.6 (31.1, 43.1)37.8 (29.8, 43.0)34.1 (28.5, 43.9)0.700.96
Sex (male)154 (54.8)117 (57.4)72 (63.7)82 (48.8)37 (71.2)25 (75.8)10 (35.7)0.250.01
Diabetes duration (yr)15.0 (9.0, 23.0)14.1 (8.7, 21.8)13.4 (5.5, 21.2)17.0 (10.9, 24.0)12.3 (4.80, 21.2)11.0 (3.70, 20.2)17.0 (11.9, 25.9)0.470.01
BMI (kg/m2)24.4 (22.4, 26.6)24.5 (22.6, 26.6)24.7 (22.5, 26.7)24.3 (22.3, 26.6)24.8 (22.6, 27.1)24.1 (22.6, 25.9)24.8 (22.4, 26.9)0.900.55
Systolic BP (mmHg)139.1 (± 18.4)137.8 (± 17.1)137.6 (± 17.2)140.0 (± 19.2)140.8 (± 20.0)131.8 (± 17.2)138.5 (± 13.7)0.970.27
HbA1c (%)8.2 (± 1.8)7.6 (± 1.0)7.9 (± 1.8)8.5 (± 1.7)7.6 (± 1.8)8.0 (± 1.7)8.4 (± 1.8)0.650.01
Total cholesterol (mmol/L)5.0 (± 1.0)4.9 (± 0.9)4.8 (± 0.9)5.1 (± 1.1)4.9 (± 1.0)4.5 (± 1.0)5.1 (± 0.7)0.740.04
eGFR (MDRD; mL/min per 1.73 m2)86.8 (± 23.0)87.8 (± 21.8)88.8 (± 15.8)85.4 (± 26.8)90.4 (± 15.0)91.1 (± 15.4)83.3 (± 16.8)0.670.27
Smoking (yes)54 (19.2)54 (26.5)31 (27.4)23 (13.6)17 (32.7)6 (18.2)8 (28.6)1.000.95
Nephropathy (present)55 (19.6)34 (16.7)17 (15.0)38 (22.6)10 (19.2)3 (9.1)4 (14.3)0.720.12
Neuropathy (present)76 (27.0)27 (13.2)12 (10.6)64 (38.1)8 (15.4)3 (9.1)1 (3.6)0.530.01
Retinopathy (present)96 (34.2)64 (31.4)32 (28.3)64 (38.1)14 (26.9)7 (21.2)11 (39.3)0.590.09
Macrovascular complications (present)2 (0.7)2 (1.0)1 (0.9)1 (0.6)1 (1.9)0 (0)0 (0)0.940.78
Albuminuria (present)48 (17.1)29 (14.2)16 (14.2)32 (19.0)9 (17.3)3 (9.1)4 (14.3)0.990.30
ACEi17 (6.0)16 (7.8)8 (7.1)9 (5.4)4 (7.7)2 (6.1)2 (7.1)0.750.39
HRQOL parameters
SF-36
MCS83.5 (71.4, 89.1)84.8 (74.6, 89.6)85.3 (77.0, 90.6)80.2 (65.99, 88.0)88.1 (82.8, 92.7)85.2 (73.4, 89.6)78.0 (68.6, 89.1)0.200.01
PCS86.8 (75.3, 92.8)87.8 (79.1, 92.9)88.7 (79.5, 93.7)83.6 (70.7, 91.2)91.4 (86.4, 94.6)88.3 (74.4, 93.3)87.4 (74.3, 91.2)0.240.01
EuroQol
EuroQol-5D1.00 (0.81, 1.00)1.00 (0.84, 1.00)1.00 (0.84, 1.00)0.95 (0.78, 1.00)1.00 (0.89, 1.00)1.00 (0.84, 1.00)1.00 (0.84, 1.00)0.390.01
EuroQol-VAS85.0 (70.0, 91.0)85.0 (75.0, 92.0)85.0 (80.0, 95.0)80.0 (70.0, 90.0)87.5 (80.0, 95.0)85.0 (70.0, 90.5)84.5 (70.8, 95.0)0.450.02
Table 2 Observed clinical parameters and health-related quality of life at long-term follow-up
Clinical characteristics1995
2002
2010
AllMDICSIIAllMDICSIIAllMDIFrom MDI to CSIICSIICSII total
(n = 281)(n = 209)(n = 72)(n = 201)(n = 110)(n = 91)(n = 113)(n = 52)(n = 33)(n = 28)(n = 61)
BMI (kg/m2)24.4 (22.4, 26.6)24.7 (22.6, 26.9)23.8 (22.2, 26.0)25.5 (23.4, 28.4)25.4 (23.2, 27.8)25.6 (23.5, 28.7)24.7 (22.5, 26.7)25.6 (24.0, 30.2)26.8(24.6, 28.8)25.4 (22.8, 29.3)26.6 (24.2, 29.0)
Systolic BP (mmHg)139.1 (± 18.4)138.9 (± 19.1)139.5 (± 16.6)130.5 (± 17.6)132.5 (± 18.0)127.8 (± 17.0)137.6 (± 17.2)131.9 (± 13.8)129.4 (± 12.9)131.1 (± 12.8)130.2 (± 12.8)
HbA1c (mmol/mol)8.2 (± 1.8)8.2 (± 1.8)8.3 (± 1.8)7.6 (± 1.0)7.7 (± 1.0)7.4 (± 1.0)7.9 (± 1.8)7.4 (± 1.0)7.6 (± 0.81)7.6 (± 0.9)7.6 (± 0.9)
Total cholesterol (mmol/L)5.0 (± 1.0)5.0 (± 1.0)5.0 (± 1.0)4.6 (± 0.9)4.6 (± 0.9)4.6 (± 1.0)4.8 (± 0.9)4.9 (± 0.9)4.9 (± 0.8)4.8 (± 0.6)6.0 (± 0.9)
eGFR (MDRD; mL/ min per 1.73 m2)86.8 (± 23.0)89.0 (± 24.6)80.5 (± 16.2)87.8 (± 21.8)81.5 (± 24.7)80.8 (± 15.0)88.8 (± 15.8)91.0 (± 21.1)92.2 (± 21.7)92.8 (± 18.7)92.5 (± 20.2)
SF-36
Subscales
Physical functioning95.0 (90.0, 100.0)95.0 (90.0, 100.0)95.0 (76.3, 98.8)95.0 (90.0, 100.0)95.0 (95.0, 100.0)95.0 (90.0, 100.0)95.0 (87.5, 100.0)95.0 (85.0, 100.0)95.0 (85.0, 100.0)95.0 (90.0, 100.0)95.0 (90.0, 100.0)
Social functioning100.0 (75.0, 100.0)100.0 (87.5, 100.0)87.5 (62.5, 100.0)100.0 (87.5, 100.0)100.0 (87.5, 100.0)100.0 (75.0, 100.0)87.5 (75.0, 100.0)93.8 (75.0, 100.0)87.5 (87.5, 100.0)87.5 (65.6, 100.0)87.5 (75.0, 100.0)
Role limitations- physical100.0 (75.0, 100.0)100.0 (100.0, 100.0)100.0 (50.0, 100.0)100.0 (100.0, 100.0)100.0 (100.0, 100.0)100.0 (68.8, 100.0)100.0 (75.0, 100.0)100.0 (100.0, 100.0)100.0 (75.0, 100.0)100.0 (56.3, 100.0)100.0 (75.0, 100.0)
Role limitations- emotional100.0 (100.0, 100.0)100.0 (100.0, 100.0)100.0 (33.3, 100.0)100.0 (100.0, 100.0)100.0 (100.0, 100.0)100.0 (66.7, 100.0)100.0 (100.0, 100.0)100.0 (100.0, 100.0)100.0 (100.0, 100.0)100.0 (100.0, 100.0)100.0 (100.0, 100.0)
Mental health80.0 (68.0, 88.0)84.0 (72.0, 92.0)74.0 (60.0, 84.0)84.0 (72.0, 88.0)84.0 (76.0, 92.0)76.0 (68.0, 84.0)84.0 (76.0, 90.0)88.0 (80.0, 92.0)84.0 (72.0, 88.0)84.0 (73.0, 88.0)84.0 (72.0, 88.0)
Vitality70.0 (55.0, 80.0)75.0 (60.0, 85.0)60.0 (41.3, 80.0)70.0 (60.0, 80.0)75.0 (60.0, 85.0)65.0 (53.8, 80.0)70.0 (55.0, 80.0)72.5 (55.0, 80.0)70.0 (57.5, 80.0)62.5 (55.0, 78.8)65.0 (65.0, 80.0)
Bodily pain100.0 (74.0, 100.0)100.0 (84.0, 100.0)84.0 (62.0, 100.0)100.0 (84.0, 100.0)100.0 (84.0, 100.0)100.0 (74.0, 100.0)100.0 (79.6, 100.0)100.0 (79.6, 100.0)89.8 (87.8, 100.0)89.8 (79.6, 100.0)89.8 (83.7, 100.0)
General Health72.0 (57.0, 87.0)72.0 (62.0, 87.0)67.0 (47.0, 82.0)72.0 (62.0, 87.0)77.0 (62.0, 87.0)72.0 (57.0, 87.0)65.0 (50.0, 75.0)65.0 (50.0, 75.0)65.0 (55.0, 75.0)65.0 (45.0, 75.0)65.0 (52.5, 75.0)
Component scores
MCS83.5 (71.4, 89.1)84.3 (75.2, 89.9)75.1 (52.5, 87.2)80.9 (66.2, 87.7)80.5 (67.3, 87.1)80.8 (63.2, 88.1)85.3 (77.0, 90.6)83.0 (67.0, 88.9)80.9 (74.4, 86.2)78.8 (66.5, 87.5)80.8 (6.80, 86.5)
PCS86.8 (75.3, 92.8)87.8 (79.3, 92.9)79.1 (57.8, 89.1)83.5 (70.5, 90.1)83.5 (73.0, 91.2)84.0 (68.8, 89.3)88.7 (79.5, 93.7)84.9 (75.8, 90.8)86.3 (74.9, 90.0)81.9 (68.2, 89.6)82.9 (74.8, 89.9)
EuroQol
EuroQol-5D1.00 (0.81, 1.00)1.00 (0.82, 1.00)0.84 (0.77, 1.00)1.00 (0.81, 1.00)1.00 (0.80, 1.00)0.95 (0.81, 1.00)1.00 (0.84, 1.00)1.00 (0.89, 1.00)1.00 (0.84, 1.00)1.00 (0.84, 1.00)1.00 (0.84, 1.00)
EuroQol-VAS85.0 (70.0, 91.0)85.0 (75.0, 91.0)80.0 (70.0, 93.8)75.0 (70.0, 85.0)75.0 (68.8, 85.0)80.0 (70.0, 86.0)85.0 (80.0, 95.0)80.0 (70.0, 90.0)80.0 (70.0, 85.0)75.0 (80.0, 85.0)75.0 (70.0, 85.0)
Table 3 Estimated changes in clinical parameters during follow-up
Clinical characteristics1995 (A)2002 (B)Difference (B-A)P-value2010 (C)Difference (C-A)P-value
BMI (kg/m2)
All24.9 (24.2, 25.5)26.2 (25.4, 27.1)1.4 (0.14, 2.6)0.0227.2 (26.3, 28.2)2.4 (1.0, 3.8)0.00
MDI25.1 (24.2, 25.9)25.9 (24.8, 27.1)0.9 (-0.9, 2.6)0.7227.0 (25.5, 28.4)1.9 (-0.1, 4.0)0.06
CSII24.9 (23.9, 26.0)27.2 (25.5, 28.8)2.3 (-0.16, 4.7)0.0827.4 (25.5, 29.1)2.5 (-0.2, 5.3)0.08
From MDI to CSII24.6 (23.5, 25.7)25.6 (24.1, 27.1)-1.0 (-1.2, 3.2)0.8227.3 (25.6, 29.1)2.7 (0.2, 5.2)0.03
Systolic BP (mmHg)
All137.0 (133.8, 140.3)128.0 (124.7, 131.2)-9.1 (-14.7, -3.5)0.00130.7 (128.1, 133.3)-6.4 (-11.4, -1.3)0.01
MDI140.8 (136.1, 145.4)131.7 (127.2, 136.3)-9.1 (- 17.0, -1.2)0.02131.6 (127.8, 135.3)-9.2 (-16.4, -2.0)0.01
CSII138.5 (132.2, 144.8)125.9 (119.5, 132.3)-12.6 (-23.6, -1.7)0.02131.1 (126.1, 136.1)-7.4 (-17.2, 2.4)0.21
From MDI to CSII131.8 (126.0, 137.7)126.3 (120.6, 132.1)-5.5 (-15.5, 4.5)0.55129.4 (124.8, 134.0)-2.5 (-11.5, 6.6)1.00
HbA1c (mmol/mol)
All8.0 (7.6, 8.3)7.6 (7.4, 7.8)-0.37 (-0.85, 0.10)0.197.5 (7.3, 7.6)-0.47 (-0.93, 0.00)0.05
MDI7.6 (7.1, 8.1)7.6 (7.3, 7.9)-0.02 (-0.70, -0.66)1.007.4 (7.1, 7.6)-0.25 (-0.91, 0.42)1.00
CSII8.3 (7.7, 9.0)7.6 (7.2, 7.9)-0.78 (-1.71, 0.14)0.137.6 (7.2, 7.9)-0.79 (-1.70, 0.12)0.11
From MDI to CSII8.0 (7.3, 8.6)7.6 (7.3, 8.0)-0.31 (-1.16, 0.54)1.007.6 (7.3, 7.9)-0.37 (-1.20, 0.47)0.87
Total cholesterol (mmol/L)
All4.8 (4.7, 5.0)4.5 (4.3, 4.7)-0.32 (-0.62, -0.01)0.044.9 (4.7, 5.0)0.04 (-0.25, 0.32)1.00
MDI4.9 (4.6, 5.2)4.6 (4.4, 4.9)-0.27 (-0.70, 0.15)0.384.9 (3.1, 6.7)-0.01 (-0.4, 0.4)1.00
CSII5.1 (4.8, 5.4)4.7 (4.3, 5.0)-0.42 (-1.00, 0.17)0.264.8 (2.4, 7.2)-0.31 (-0.9, 0.24)1.00
From MDI to CSII4.5 (4.2, 4.8)4.2 (3.9, 4.5)-0.26 (-0.79, 0.29)0.774.9 (4.6, 5.2)0.42 (-0.1, 0.93)0.15
eGFR (MDRD; mL/min per 1.73 m2)
All88.3 (85.3, 91.3)83.3 (80.9, 85.8)-4.9 (-9.7, -0.2)0.3792.0 (87.9, 96.1)-3.7 (-2.5, -9.9)0.44
MDI90.4 (86.6, 94.7)83.9 (80.4, 87.4)-6.5 (-13.2, 0.27)0.6591.0 (85.3, 96.7)0.6 (-8.0, 9.4)1.00
CSII83.3 (77.5, 89.2)80.6 (75.8, 85.4)-2.7 (-11.9, 6.5)1.0092.8 (84.7, 100.8)9.4 (-2.7, 21.6)0.19
From MDI to CSII91.1 (85.7, 96.5)85.5 (81.0, 89.9)-5.7 (-14.1, 2.8)0.3292.2 (84.9, 99.5)1.1 (-9.9, 12.1)1.00
Table 4 Estimated changes in health-related quality of life during follow-up
HRQOL parameters1995 (A) mean2002 (B) meanMean difference (B-A)P-value2010 (C) meanMean difference (C-A)P-value
SF-36
MCS
All81.3 (78.9, 83.7)78.3 (75.6, 81.0)-3.0 (-7.4, 1.4)0.3177.1 (74.2, 80.0)-4.2 (-8.7, 0.41)0.09
MDI86.8 (83.4, 90.3)a80.4 (76.5, 84.3)-6.5 (-12.8, -0.14)0.0477.1 (72.9, 81.2)-9.8 (-16.3, -3.2)0.01
CSII78.0 (73.4, 82.6)77.0 (71.8, 82.3)-1.00 (-9.5, 7.5)1.0076.5 (70.9, 82.1)-1.6 (-10.4, 7.3)1.00
From MDI to CSII79.0 (74.8, 83.3)77.5 (72.7, 82.3)-1.5 (-9.3, 6.3)1.0077.9 (72.7, 83.1)-1.1 (-9.2, 7.0)1.00
PCS
All84.1 (81.6, 86.5)81.1 (78.4, 83.8)-3.0 (-7.5, 1.4)0.3179.5 (76.5, 82.4)-4.6 (-9.3, 0.07)0.06
MDI88.7 (85.1, 92.2)84.3 (80.3, 88.2)-4.4 (-10.9, 2.0)0.2980.1 (75.9, 84.3)-8.6 (-15.3, -1.8)0.01
CSII81.5 (76.7, 86.2)79.3 (74.2, 84.5)-2.1 (-10.7, 6.5)1.0077.8 (72.0, 83.5)-3.7 (-12.8, 5.4)0.98
From MDI to CSII82.1 (77.7, 86.5)79.6 (74.8, 84.4)-2.5 (-10.4, 5.4)1.0080.5 (75.2, 85.8)-1.6 (-9.9, 6.8)1.00
EuroQol
EuroQol-5D
All0.94 (0.92, 0.95)0.91 (0.89, 0.93)-0.03 (-0.06, 0.01)0.120.94 (0.92, 0.95)0.00 (0.03, -0.03)1.00
MDI0.96 (0.93, 0.98)0.92 (0.88, 0.95)-0.4 (-0.9, 0.01)0.120.96 (0.93, 0.98)0.00 (0.04, -0.04)1.00
CSII0.93 (0.90, 0.97)0.91 (0.87, 0.95)0.3 (-0.9, 0.04)0.980.93 (0.90, 0.97)0.00 (0.06, -0.06)1.00
From MDI to CSII0.92 (0.89, 0.95)0.90 (0.86, 0.94)0.02 (-0.08, 0.04)1.000.92 (0.89, 0.95)0.00 (0.05, -0.05)1.00
EuroQol-VAS
All83.6 (81.4, 85.9)76.9 (74.4, 79.5)-6.7 (-10.9, 2.5)0.0176.3 (73.8, 78.8)-7.3 (-11.4, -3.3)0.01
MDI86.4 (83.1, 89.7)78.3 (74.6, 82.0)-8.1 (-14.1, -2.1)0.0178.3 (74.8, 81.8)-8.1 (-14.0, -2.3)0.01
CSII82.9 (78.5, 87.2)76.4 (71.4, 81.3)-6.5 (-14.5, 1.6)0.1673.3 (68.5, 78.1)-9.6 (-17.5, -1.7)0.01
From MDI to CSII81.6 (77.6, 85.6)76.1 (71.5, 80.6)-5.5 (-12.9, 1.9)0.2277.3 (73.0, 81.6)-4.3 (-11.5, 2.9)0.45