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Table 1

Baseline characteristics of the study population and of the study sites at which the participants were enrolled, with univariate (unadjusted) HRs for CV mortality

Baseline characteristicValueHR (95% CI)POverall P
Age (years) 62.2 ± 6.8 1.07 (1.05, 1.08) <0.001  
Female 3,906 (38.4) 0.57 (0.44, 0.73) <0.001  
Race/ethnicity    0.097 
 African American 1,927 (19.0) 0.90 (0.68, 1.19) 0.466  
 Hispanic 727 (7.2) 0.83 (0.53, 1.30) 0.424  
 Other 1,110 (10.9) 0.59 (0.39, 0.90) 0.015  
 Non-Hispanic white 6,399 (63.0)   
Diabetes duration (years)    <0.001 
 ≤5 2,988 (29.4)   
 6–10 2,914 (28.7) 0.85 (0.62, 1.17) 0.316  
 11–15 1,942 (19.1) 0.98 (0.70, 1.37) 0.905  
 ≥16 2,319 (22.8) 1.68 (1.27, 2.23) <0.001  
History of CV disease (yes vs. no) 3,576 (35.2) 3.11 (2.49, 3.88) <0.001  
Prior myocardial infarction (yes vs. no) 471 (4.6) 2.87 (2.05, 4.00) <0.001  
Heart failure/congestive heart failure (yes vs. no) 491 (4.9) 4.57 (3.43, 6.09) <0.001  
Retinal surgery (yes vs. no) 890 (8.8) 1.56 (1.13, 2.15) 0.007  
Amputation (yes vs. no) 184 (1.8) 3.32 (2.06, 5.33) <0.001  
Education    <0.001 
 Less than high school 1,501 (14.8) 2.30 (1.65, 3.21) <0.001  
 High school graduate 2,682 (26.4) 1.39 (1.00, 1.93) 0.048  
 Some college 3,330 (32.8) 1.34 (0.98, 1.84) 0.068  
 College graduate or more 2,643 (26.0)   
Smoking    0.001 
 Former 4,492 (44.2) 1.56 (1.23, 1.98) <0.001  
 Current 1,411 (13.9) 1.30 (0.92, 1.85) 0.140  
 Never 4,260 (41.9)   
Alcohol use    0.348 
 1–6 drinks/week 1,963 (19.3) 0.82 (0.61, 1.09) 0.171  
 ≥7 drinks/week 470 (4.6) 1.09 (0.67, 1.78) 0.733  
 No drinks/week 7,725 (76.0)   
Insulin use (yes vs. no) 3,559 (35.0) 1.69 (1.36, 2.10) <0.001  
ACE inhibitor (yes vs. no) 5,397 (53.1) 1.18 (0.95, 1.47) 0.135  
Angiotensin receptor blockers (yes vs. no) 1,618 (15.9) 0.67 (0.47, 0.95) 0.024  
Statins (yes vs. no) 6,311 (62.1) 1.16 (0.93, 1.46) 0.194  
Metformin (yes vs. no) 6,080 (59.8) 0.90 (0.73, 1.12) 0.360  
Sulfonylureas (yes vs. no) 5,092 (50.1) 0.77 (0.62, 0.96) 0.021  
Thiazolidinediones (yes vs. no) 1,967 (19.4) 0.76 (0.57, 1.03) 0.077  
BMI (kg/m232.2 ± 5.5 1.01 (0.99, 1.03) 0.382  
Systolic blood pressure (mmHg) 136.3 ± 17.1 1.00 (1.00, 1.01) 0.365  
Diastolic blood pressure (mmHg) 74.9 ± 10.6 0.98 (0.97, 0.99) <0.001  
Visual acuity    <0.001 
 <20/40 2,310 (23.8) 3.22 (2.06, 5.04) <0.001  
 20/20–20/40 5,906 (60.8) 1.97 (1.28, 3.04) 0.002  
 ≥20/20 1,502 (15.5)   
Peripheral neuropathy (yes vs. no) 4,328 (42.7) 1.86 (1.49, 2.31) <0.001  
Heart rate 72.6 ± 11.7 1.00 (0.99, 1.01) 0.847  
Q-T index 101.7 ± 5.2 1.06 (1.04, 1.07) <0.001  
A1C in % (mmol/mol) 8.3 ± 1.1 (67 ± 1) 1.19 (1.09, 1.31) <0.001  
Fasting plasma glucose (mg/dL) 175.3 ± 56.2 1.00 (1.00, 1.00) 0.258  
LDL (mg/dL) 104.9 ± 33.9 1.00 (1.00, 1.00) 0.515  
HDL (mg/dL) 41.8 ± 11.6 0.98 (0.97, 0.99) <0.001  
Triglycerides (mg/dL) 190.3 ± 148.7 1.00 (1.00, 1.00) 0.928  
Serum creatinine (mg/dL) 0.9 ± 0.2 4.04 (2.81, 5.82) <0.001  
Urinary albumin-to-creatinine ratio (mg/mg)    <0.001 
 <30 6,937 (68.8)   
 30 to ≤300 2,481 (24.6) 1.96 (1.54, 2.49) <0.001  
 >300 670 (6.6) 3.71 (2.73, 5.04) <0.001  
Integrated health plan (yes vs. no) 4,050 (39.9) 1.41 (1.13, 1.75) 0.002  
Endocrinologist or diabetologist (either vs. other physician) 5,664 (55.7) 0.81 (0.65, 1.00) 0.052  
Certified diabetes educator on staff at randomization 3,927 (38.6) 0.78 (0.62, 0.98) 0.030  
Site size    0.978 
 <100 1,568 (15.4) 0.99 (0.72, 1.37) 0.969  
 100–150 3,027 (29.8) 1.02 (0.80, 1.31) 0.848  
 >150 5,568 (54.8)   
Baseline characteristicValueHR (95% CI)POverall P
Age (years) 62.2 ± 6.8 1.07 (1.05, 1.08) <0.001  
Female 3,906 (38.4) 0.57 (0.44, 0.73) <0.001  
Race/ethnicity    0.097 
 African American 1,927 (19.0) 0.90 (0.68, 1.19) 0.466  
 Hispanic 727 (7.2) 0.83 (0.53, 1.30) 0.424  
 Other 1,110 (10.9) 0.59 (0.39, 0.90) 0.015  
 Non-Hispanic white 6,399 (63.0)   
Diabetes duration (years)    <0.001 
 ≤5 2,988 (29.4)   
 6–10 2,914 (28.7) 0.85 (0.62, 1.17) 0.316  
 11–15 1,942 (19.1) 0.98 (0.70, 1.37) 0.905  
 ≥16 2,319 (22.8) 1.68 (1.27, 2.23) <0.001  
History of CV disease (yes vs. no) 3,576 (35.2) 3.11 (2.49, 3.88) <0.001  
Prior myocardial infarction (yes vs. no) 471 (4.6) 2.87 (2.05, 4.00) <0.001  
Heart failure/congestive heart failure (yes vs. no) 491 (4.9) 4.57 (3.43, 6.09) <0.001  
Retinal surgery (yes vs. no) 890 (8.8) 1.56 (1.13, 2.15) 0.007  
Amputation (yes vs. no) 184 (1.8) 3.32 (2.06, 5.33) <0.001  
Education    <0.001 
 Less than high school 1,501 (14.8) 2.30 (1.65, 3.21) <0.001  
 High school graduate 2,682 (26.4) 1.39 (1.00, 1.93) 0.048  
 Some college 3,330 (32.8) 1.34 (0.98, 1.84) 0.068  
 College graduate or more 2,643 (26.0)   
Smoking    0.001 
 Former 4,492 (44.2) 1.56 (1.23, 1.98) <0.001  
 Current 1,411 (13.9) 1.30 (0.92, 1.85) 0.140  
 Never 4,260 (41.9)   
Alcohol use    0.348 
 1–6 drinks/week 1,963 (19.3) 0.82 (0.61, 1.09) 0.171  
 ≥7 drinks/week 470 (4.6) 1.09 (0.67, 1.78) 0.733  
 No drinks/week 7,725 (76.0)   
Insulin use (yes vs. no) 3,559 (35.0) 1.69 (1.36, 2.10) <0.001  
ACE inhibitor (yes vs. no) 5,397 (53.1) 1.18 (0.95, 1.47) 0.135  
Angiotensin receptor blockers (yes vs. no) 1,618 (15.9) 0.67 (0.47, 0.95) 0.024  
Statins (yes vs. no) 6,311 (62.1) 1.16 (0.93, 1.46) 0.194  
Metformin (yes vs. no) 6,080 (59.8) 0.90 (0.73, 1.12) 0.360  
Sulfonylureas (yes vs. no) 5,092 (50.1) 0.77 (0.62, 0.96) 0.021  
Thiazolidinediones (yes vs. no) 1,967 (19.4) 0.76 (0.57, 1.03) 0.077  
BMI (kg/m232.2 ± 5.5 1.01 (0.99, 1.03) 0.382  
Systolic blood pressure (mmHg) 136.3 ± 17.1 1.00 (1.00, 1.01) 0.365  
Diastolic blood pressure (mmHg) 74.9 ± 10.6 0.98 (0.97, 0.99) <0.001  
Visual acuity    <0.001 
 <20/40 2,310 (23.8) 3.22 (2.06, 5.04) <0.001  
 20/20–20/40 5,906 (60.8) 1.97 (1.28, 3.04) 0.002  
 ≥20/20 1,502 (15.5)   
Peripheral neuropathy (yes vs. no) 4,328 (42.7) 1.86 (1.49, 2.31) <0.001  
Heart rate 72.6 ± 11.7 1.00 (0.99, 1.01) 0.847  
Q-T index 101.7 ± 5.2 1.06 (1.04, 1.07) <0.001  
A1C in % (mmol/mol) 8.3 ± 1.1 (67 ± 1) 1.19 (1.09, 1.31) <0.001  
Fasting plasma glucose (mg/dL) 175.3 ± 56.2 1.00 (1.00, 1.00) 0.258  
LDL (mg/dL) 104.9 ± 33.9 1.00 (1.00, 1.00) 0.515  
HDL (mg/dL) 41.8 ± 11.6 0.98 (0.97, 0.99) <0.001  
Triglycerides (mg/dL) 190.3 ± 148.7 1.00 (1.00, 1.00) 0.928  
Serum creatinine (mg/dL) 0.9 ± 0.2 4.04 (2.81, 5.82) <0.001  
Urinary albumin-to-creatinine ratio (mg/mg)    <0.001 
 <30 6,937 (68.8)   
 30 to ≤300 2,481 (24.6) 1.96 (1.54, 2.49) <0.001  
 >300 670 (6.6) 3.71 (2.73, 5.04) <0.001  
Integrated health plan (yes vs. no) 4,050 (39.9) 1.41 (1.13, 1.75) 0.002  
Endocrinologist or diabetologist (either vs. other physician) 5,664 (55.7) 0.81 (0.65, 1.00) 0.052  
Certified diabetes educator on staff at randomization 3,927 (38.6) 0.78 (0.62, 0.98) 0.030  
Site size    0.978 
 <100 1,568 (15.4) 0.99 (0.72, 1.37) 0.969  
 100–150 3,027 (29.8) 1.02 (0.80, 1.31) 0.848  
 >150 5,568 (54.8)   

Values are means ± SD or n (%).

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