Background
Methods
Study design
Data sources
Site and patient selection
Study population
Study objectives
Sample population size
Subgroups of interest
Statistical analysis
Results
Patient characteristics
Variable | Total | Treatment Strategy |
P
| ||
---|---|---|---|---|---|
A | B | C | |||
Patients n (%) | 1189 (100%) | 241 (20.3%) | 478 (40.2%) | 470 (39.5%) | |
Sex n (%) | |||||
Male | 601 (50.5%) | 125 (51.9%) | 241 (50.4%) | 235 (50%) | 0.856 a |
Female | 588 (49.5) | 116 (48.1%) | 237 (49.6%) | 235 (50%) | |
Diabetes Duration (years) (mean ± SD) | 11.2 ± 8.6 | 5.2 ± 5.7 | 10.1 ± 7.5 | 15.3 ± 8.6 | |
Years under Treatment (median – IQR) | 10 (4–16) | 4 (1–7) | 9 (4–14) | 15 (9–20) | < 0.001 b |
Age (years) (median - IQR) | 65 (58–72) | 63 (56–70) | 65 (58–72) | 67 (58–73) | 0.002 b |
Age group | |||||
< 60 | 362 (30.4%) | 89 (36.9%) | 139 (29.1%) | 134 (28.5%) | 0.041 a |
60–70 | 477 (40.2%) | 97 (40.2%) | 198 (41.4%) | 182 (38.7%) | |
> 70 | 350 (29.4) | 55 (22.8%) | 141 (29.5%) | 154 (32.8%) | |
Height (cm) (median – IQR) | 165 (158–172) | 165 (158–172) | 165 (158–172) | 165 (158–172) | |
Weight (kg) (median – IQR) | 82 (73–93) | 80 (70–90) | 82 (73–92.5) | 83 (73–96) | |
Body Mass Index (kg/m2) (median – IQR) | 30 (26.75–33.8) | 29.4 (26.6–32.6) | 30 (26.8–33.7) | 30.1 (26.6–34.7) | |
Systolic blood pressure (mmHg) (median – IQR) | 130 (120–140) | 130 (120–140) | 130 (120–140) | 134 (125–145) | 0.03 b |
Diastolic blood pressure (mmHg) (median – IQR) | 80 (70–85) | 80 (70–85) | 80 (70–84) | 80 (70–83) | |
eGFR (mL/min/1.73 m2) (median – IQR) | 73.9 (60.6–93.2) | 78.1 (59.9–96.1) | 74.3 (62.0–94.5) | 73.1 (60.4–89.3) | < 0.001b |
Microalbumin urine (mcg/mg creatinine) (median – IQR) | 18 (10–45) | 14 (7–30) | 16 (9–40) | 24 (11–78.4) | < 0.001b |
Total Serum Cholesterol (mg/dl) (median – IQR) | 173 (150–200) | 183 (156–204) | 174 (152–201) | 166 (146–193) | < 0.001b |
Serum Triglycerides (mg/dl) (median – IQR) | 127 (95–174) | 126 (96–176) | 125.5 (95–175) | 127.5 (94.5–171.5) | |
Serum LDL-C (mg/dl) (median – IQR) | 97 (76–120) | 104 (81–125) | 96 (75–121) | 92 (74–114) | 0.03b |
Serum HDL-C (mg/dl) (median – IQR) | 46 (39–56) | 47 (41–57) | 48 (39–57) | 45 (39–53) | |
Marital status n (%) | |||||
Married | 1003 (84.4%) | 202 (83.8%) | 410 (85.8%) | 391 (83.2%) | 0.679a |
Unmarried | 56 (4.7%) | 15 (6.2%) | 18 (3.8%) | 23 (4.9%) | |
Divorced | 39 (3.3%) | 9 (3.7%) | 13 (2.7%) | 17 (3.6%) | |
Widower / Widow | 91 (7.7%) | 15 (6.2%) | 37 (7.7%) | 39 (8.3%) | |
Living Status n (%) | |||||
Lives with his / her family | 1066 (89.7%) | 214 (88.8%) | 431 (90.2%) | 421 (89.6%) | 0.848a |
Lives alone | 123 (10.3%) | 27 (11.2%) | 47 (9.8%) | 49 (10.4%) | |
Resident n (%) | |||||
Village | 237 (19.9%) | 48 (19.9%) | 93 (19.5%) | 96 (20.4%) | 0.689a |
Provincial town | 133 (11.2%) | 32 (13.3%) | 44 (9.2%) | 57 (12.1%) | |
Provincial city | 179 (15.1%) | 37 (15.4%) | 79 (16.5%) | 63 (13.4%) | |
Prefectural capital | 314 (26.4%) | 61 (25.3%) | 124 (25.9%) | 129 (27.4%) | |
Urban center | 326 (27.4%) | 63 (26.1%) | 138 (28.9%) | 125 (26.6%) | |
Self-care Capability n (%) | |||||
Capable of self-care | 1139 (95.8%) | 238 (98.8%) | 462 (96.7%) | 439 (93.4%) |
0.009
a
|
Needs help sometimes | 45 (3.8%) | 3 (1.2%) | 15 (3.1%) | 27 (5.7%) | |
Dependent | 5 (0.4%) | 0 (0.0%) | 1 (0.2%) | 4 (0.9%) | |
Access to Health Services n (%) | |||||
Difficult | 15 (1.3%) | 4 (1.7%) | 4 (0.8%) | 7 (1.5%) | 0.914a |
Occasional | 68 (5.7%) | 15 (6.2%) | 29 (6.1%) | 24 (5.1%) | |
Easy | 402 (33.8%) | 83 (34.4%) | 166 (34.7%) | 153 (32.6%) | |
Regular | 440 (37%) | 88 (36.5%) | 179 (37.4%) | 173 (36.8%) | |
Systematic | 264 (22.2%) | 51 (21.2%) | 100 (20.9%) | 113 (24.0%) | |
Education n (%) | |||||
Illiterate | 59 (5%) | 10 (4.1%) | 25 (5.2%) | 24 (5.1%) |
0.032
a
|
Basic education | 592 (49.8%) | 115 (47.7%) | 224 (46.9%) | 253 (53.8%) | |
Secondary education | 365 (30.7%) | 67 (27.8%) | 165 (34.5%) | 133 (28.3%) | |
Higher education | 173 (14.6%) | 49 (20.3%) | 64 (13.4%) | 60 (12.8%) | |
Occupation n (%) | |||||
Manual work | 239 (20.1%) | 50 (20.7%) | 94 (19.7%) | 95 (20.2%) | 0.101a |
Office work | 151 (12.7%) | 39 (16.2%) | 68 (14.2%) | 44 (9.4%) | |
Intellectual work | 26 (2.2%) | 7 (2.9%) | 11 (2.3%) | 8 (1.7%) | |
Pensioner | 621 (52.2%) | 109 (45.2%) | 248 (51.9%) | 264 (56.2%) | |
Unemployed | 152 (12.8%) | 36 (14.9%) | 57 (11.9%) | 59 (12.6%) | |
Financial Status n (%) | |||||
NA | 5 (0.4%) | 2 (0.8%) | 0 (0.0%) | 3 (0.6%) | 0.324a |
Indigent | 14 (1.2%) | 4 (1.7%) | 5 (1.0%) | 5 (1.1%) | |
Poor | 171 (14.4%) | 37 (15.4%) | 55 (11.5%) | 79 (16.8%) | |
Moderate financial status | 891 (74.9%) | 173 (71.8%) | 376 (78.7%) | 342 (72.8%) | |
Financial comfort | 92 (7.7%) | 21 (8.7%) | 37 (7.7%) | 34 (7.2%) | |
Wealthy | 16 (1.3%) | 4 (1.7%) | 5 (1.0%) | 7 (1.5%) | |
Insured n (%) | |||||
No | 24 (2%) | 6 (2.5%) | 10 (2.1%) | 8 (1.7%) | 0.771a |
Yes | 1165 (98%) | 235 (97.5%) | 468 (97.9%) | 462 (98.3%) |
Complication n (%) | Total | Treatment Strategy |
P
| ||
---|---|---|---|---|---|
A | B | C | |||
Acute complications | 15 (3.7%) | 2 (0.5%) | 1 (0.2%) | 12 (2.9%) | NA |
Non-ketotic Hyperglycaemic Hyperosmolar Coma | 2 (0.2%) | 1 (0.4%) | 0 (0%) | 1 (0.2%) | NA |
Infections | 2 (0.2%) | 0 (0%) | 0 (0%) | 2 (0.4%) | NA |
Diabetes-associated Hospitalisation | 3 (0.3%) | 0 (0%) | 0 (0%) | 3 (0,6%) | NA |
Other | 7 (0.6%) | 1 (0.4%) | 1 (0.2%) | 5 (1.1%) | NA |
Chronic complications | 386 (32.5%) | 29 (12.0%) | 130 (27.2%) | 227 (48.3%) | |
Diabetic Retinopathy | 141 (11.9%) | 6 (2.5%) | 36 (7.5%) | 99 (21.1%) | < 0.001 |
Diabetic Nephropathy | 140 (11.8%) | 16 (6.6%) | 43 (9.0%) | 81 (17.2%) | < 0.001 |
Diabetic Neuropathy | 136 (11.4%) | 7 (2.9%) | 33 (6.9%) | 96 (20.4%) | < 0.001 |
Diabetic Foot: ulcers | 14 (1.2%) | 1 (0.4%) | 6 (1.3%) | 7 (1.5%) | NA |
Diabetic Foot: extensive superficial lesions | 7 (0.6%) | 1 (0.4%) | 3 (0.6%) | 3 (0.6%) | NA |
Diabetic Foot: gangrene | 2 (0.2%) | 0 (0%) | 0 (0%) | 2 (0.4%) | NA |
Diabetic Foot: lower extremity amputation | 3 (0.3%) | 0 (0%) | 0 (0%) | 3 (0.6%) | NA |
Cardiovascular events | 69 (5.8%) | 4 (1.7%) | 29 (6.1%) | 36 (7.7%) | 0.005 |
Carotid Artery Disease | 24 (2.0%) | 3 (1.2%) | 2 (0.4%) | 19 (4.0%) | < 0.001 |
Peripheral Arterial Disease | 48 (4%) | 3 (1.2%) | 12 (2.5%) | 33 (7%) | < 0.001 |
Other | 23 (1.9%) | 2 (0.8%) | 7 (1.5%) | 14 (3%) | 0.09 |
Collection and analysis of data on current clinical practice in T2DM management and relevant treatment patterns in public sector in Greece
Variable | Initial diagnosis | Current period | |||||||
---|---|---|---|---|---|---|---|---|---|
Treatment Strategy | Treatment Strategy |
P
| |||||||
All | A | B | C | All | A | B | C | ||
Patients n (%) | 1189 (100%) | 722 (60.7%) | 334 (28.1%) | 133 (11.2%) | 1189 (100%) | 241 (20.3%) | 478 (40.2%) | 470 (39.5%) | |
Full analysis set, n | 572 (100%) | 359 (62.8%) | 151 (26.4%) | 62 (10.8%) | 1120 (100%) | 225 (20.1%) | 452 (40.4%) | 443 (39.6%) | |
HbA1c % | |||||||||
Median (IQR) | 7.8 (7.0–9.0) | 7.5 (6.8–8.2) | 8.6 (7.7–10.0) | 10.0 (8.5–11.7) | 6.9 (6.3–7.5) | 6.4 (6.0–7.0) | 6.7 (6.3–7.2) | 7.3 (6.7–8.0) | < 0.001b |
Mean ± SD | 8.4 ± 1.4 | 7.5 ± 1.6 | 8.3 ± 1.1 | 9.3 ± 2.2 | 7.1 ± 1.2 | 6.6 ± 1.0 | 6.9 ± 1.1 | 7.5 ± 1.2 | |
Adjustedc mean ± SD | 8.1 ± 0.2 | 8.3 ± 0.1 | 8.5 ± 0.1 | 7.0 ± 0.1 | 7.0 ± 0.1 | 7.2 ± 0.1 | 0.771 | ||
< 6.5% | 42 (7.0%) | 38 (10.0%) | 3 (1.0%) | 1 (1.0%) | 339 (30.0%) | 115 (51.1%) | 159 (35.2%) | 65 (14.7%) | < 0.001a |
[6.5–7.0%) | 73 (12.0%) | 65 (18.0%) | 8 (5.0%) | 0 (0%) | 259 (23.0%) | 52 (23.1%) | 115 (25.4%) | 92 (20.7%) | |
< 7.0% | 115 (19.0%) | 103 (28.0%) | 11 (6.0%) | 1 (1.0%) | 598 (53.0%) | 167 (74.2%) | 274 (60.6%) | 157 (35.4%) | |
[7.0–7.5%) | 92 (16.0%) | 73 (20.0%) | 16 (10.0%) | 3 (4.0%) | 218 (19.0%) | 34 (15.1%) | 94 (20.8%) | 90 (20.3%) | |
[7.5–8.0%] | 119 (20.0%) | 81 (22.0%) | 30 (19.0%) | 8 (12.0%) | 149 (13.0%) | 14 (6.2%) | 42 (9.3%) | 93 (21.0%) | |
> 8.0% | 246 (43.0%) | 102 (28.0%) | 94 (62.0%) | 50 (80.0%) | 155 (13.0%) | 10 (4.5%) | 42 (9.3%) | 103 (23.3%) | |
FPG mg/dl | |||||||||
Median (IQR) | 177 (142–234) | 160 (135–200) | 200 (160–259) | 240 (186–350) | 126 (110–150) | 120 (107–135) | 126 (110–150) | 130 (111–161) | < 0.001b |
Mean ± SD | 201 ± 85 | 179 ± 63 | 221 ± 82 | 280 ± 133 | 136 ± 42 | 126 ± 32 | 135 ± 41 | 141 ± 46 | |
Adjustedc mean ± SD | 189.4 ± 6.9 | 201.1 ± 4.7 | 206.3 ± 5.1 | 134.8 ± 3.0 | 133.1 ± 2.0 | 138.6 ± 2.1 | 0.180 | ||
Median (IQR) | NA | NA | NA | NA | 144 (130–160) | 152 (138–178) | 170 (145–200) | 144 (130–160) | < 0.001b |
Adjustedc mean ± SD | NA | NA | NA | NA | 163.2 ± 3.7 | 166.0 ± 2.5 | 169.6 ± 2.6 | 0.375 |
Identification of factors that potentially influence clinical decisions and guide management strategies in T2DM
Decision criteria (Score 1–10) | Treatment Strategy |
P
| |||||
---|---|---|---|---|---|---|---|
A | B | C | |||||
Median | IQR | Median | IQR | Median | IQR | ||
Adjustment to patient’s peculiarities, principles / values & personal characteristics | 10 | (9–10) | 9 | (8–10) | 8 | (7–10) | < 0.01 |
Simplicity and convenience of treatment regimen | 10 | (9–10) | 9 | (8–10) | 8 | (7–9) | < 0.01 |
Compliance with International and Greek Guidelines for the management of DM-2 | 10 | (9–10) | 10 | (8–10) | 9 | (8–10) | < 0.01 |
Choice due to corresponding physician’s clinical experience and / or familiarity | 10 | (9–10) | 9 | (8–10) | 9 | (8–10) | < 0.01 |
Compliance with the specific administration indications of the formulations | 10 | (9–10) | 9 | (8–10) | 9 | (8–10) | < 0.02 |
Compliance with Prescribing Guidelines from Regulatory Agencies or Insurance Funds | 10 | (8–10) | 9 | (8–10) | 9 | (8–10) | < 0.01 |
Greater Efficacy of the specific treatment | 10 | (9–10) | 9 | (8–10) | 9 | (8–10) | < 0.02 |
Greater Safety of the specific treatment | 10 | (9–10) | 9 | (8–10) | 9 | (8–10) | 0.01 |
Better efficacy / safety combination with the specific treatment | 10 | (9–10) | 9 | (8–10) | 9 | (8–10) | < 0.01 |
Pursuing the lowest possible cost for the patient | 10 | (8–10) | 8 | (7–10) | 8 | (6–9) | < 0.01 |
Pursuing the lowest possible burden for Government Funds | 10 | (8–10) | 8 | (6–10) | 8 | (6–9) | < 0.01 |
Better financial cost and clinical benefit (efficacy) ratio | 10 | (8–10) | 9 | (8–10) | 8 | (7–9) | < 0.01 |
Minimization of adverse reactions from treatment | 10 | (9–10) | 9 | (8–10) | 9 | (8–10) | < 0.01 |