Table 1 ITT Comparison of Baseline Variables between Groups
All Patients (n = 86) | SOC + PMDC (n = 44) | SOC (n = 42) | P-Value | |
|---|---|---|---|---|
Age | ||||
Mean (Standard Deviation) | 52.69 (8.92) | 52.00 (9.67) | 53.40 (8.10) | 0.4684 |
Gender | ||||
Female | 50 (58.14%) | 24 (54.55%) | 26 (61.90%) | 0.4892 |
Male | 36 (41.86%) | 20 (45.45%) | 16 (38.10%) | |
Race | ||||
Caucasian | 38 (44.19%) | 17 (38.64%) | 21 (50.00%) | 0.5605 |
African American | 46 (53.49%) | 26 (59.09%) | 20 (47.62) | |
Hispanic | 2 (2.33%) | 1 (2.27%) | 1 (2.38%) | |
Body Mass Index (BMI) | (n = 85) | (n = 43) | ||
Mean (Standard Deviation) | 36.66 (8.62) | 37.54 (8.15) | 35.76 (9.08) | 0.3446 |
Systolic Blood Pressure (SBP) | (n = 85) | (n = 41) | ||
Mean (Standard Deviation) | 138.46 (20.93) | 141.55 (23.17) | 135.15 (17.92) | 0.1602 |
Diastolic Blood Pressure (DBP) | (n = 85) | (n = 41) | ||
Mean (Standard Deviation) | 80.52 (12.30) | 81.59 (13.90) | 79.37 (10.37) | 0.4080 |
Creatinine | ||||
Mean (Standard Deviation) | 1.09 (0.85) | 1.07 (0.46) | 1.12 (1.13) | 0.7920 |
eGFR | ||||
Mean (Standard Deviation) | 82.71 (24.26) | 82.66 (25.47) | 82.76 (23.23) | 0.9845 |
Microalbumin | (n = 75) | (n = 38) | (n = 37) | |
Mean (Standard Deviation) | 17.27 (37.45) | 24.36 (46.60) | 9.98 (23.31) | 0.0954 |
Total Cholesterol | (n = 83) | (n = 42) | (n = 41) | |
Mean (Standard Deviation) | 169.54 (47.53) | 168.50 (52.69) | 170.61 (42.22) | 0.8412 |
LDL | (n = 79) | (n = 41) | (n = 38) | |
Mean (Standard Deviation) | 93.94 (37.89) | 93.78 (40.41) | 94.11 (35.51) | 0.9699 |
HDL | (n = 83) | (n = 42) | (n = 41) | |
Mean (Standard Deviation) | 43.67 (12.51) | 42.90 (12.35) | 44.46 (12.77) | 0.5735 |
Triglycerides | (n = 83) | (n = 42) | (n = 41) | |
Mean (Standard Deviation) | 182.25 (143.49) | 172.83 (126.42) | 191.90 (160.12) | 0.5482 |
Tobacco Use | ||||
Never | 42 (48.84%) | 20 (45.45%) | 22 (52.38%) | 0.8021 |
Current | 17 (19.77%) | 9 (20.45%) | 8 (19.05%) | |
Former | 27 (31.40%) | 15 (34.09%) | 12 (28.57%) | |
Neuropathy | ||||
Yes | 46 (53.49%) | 25 (56.82%) | 21 (50.00%) | 0.5263 |
No | 40 (46.51%) | 19 (43.18%) | 21 (50.00%) | |
Retinopathy | ||||
Yes | 33 (38.37%) | 16 (36.36%) | 17 (40.48%) | 0.6950 |
No | 53 (61.63%) | 28 (63.64%) | 25 (59.52%) | |
Nephropathy | ||||
Yes | 62 (72.09%) | 33 (75.00%) | 29 (69.05%) | 0.5384 |
No | 24 (27.91%) | 11 (25.00%) | 13 (30.95%) | |
Macrovascular Complications (MI, Stroke) | ||||
Yes | 11 (12.79%) | 7 (15.91%) | 4 (9.52%) | 0.3755 |
No | 75 (87.21%) | 37 (84.09%) | 38 (90.48%) | |
Oral Agents Only | ||||
Yes | 28 (32.56%) | 14 (31.82%) | 14 (33.33%) | 0.8809 |
No | 58 (67.44%) | 30 (68.18%) | 28 (66.67%) | |
Insulin Regimen | ||||
Yes | 70 (81.40%) | 38 (86.36%) | 32 (76.19%) | 0.2256 |
No | 16 (18.60%) | 6 (13.64%) | 10 (23.81%) | |
Statin | ||||
Yes | 72 (83.72%) | 35 (79.55%) | 37 (88.10%) | 0.2830 |
No | 14 (16.28%) | 9 (20.45%) | 5 (11.90%) | |