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 ± 6.81.07 (1.05, 1.08)<0.001
Female3,906 (38.4)0.57 (0.44, 0.73)<0.001
Race/ethnicity0.097
 African American1,927 (19.0)0.90 (0.68, 1.19)0.466
 Hispanic727 (7.2)0.83 (0.53, 1.30)0.424
 Other1,110 (10.9)0.59 (0.39, 0.90)0.015
 Non-Hispanic white6,399 (63.0)1
Diabetes duration (years)<0.001
 ≤52,988 (29.4)1
 6–102,914 (28.7)0.85 (0.62, 1.17)0.316
 11–151,942 (19.1)0.98 (0.70, 1.37)0.905
 ≥162,319 (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 school1,501 (14.8)2.30 (1.65, 3.21)<0.001
 High school graduate2,682 (26.4)1.39 (1.00, 1.93)0.048
 Some college3,330 (32.8)1.34 (0.98, 1.84)0.068
 College graduate or more2,643 (26.0)1
Smoking0.001
 Former4,492 (44.2)1.56 (1.23, 1.98)<0.001
 Current1,411 (13.9)1.30 (0.92, 1.85)0.140
 Never4,260 (41.9)1
Alcohol use0.348
 1–6 drinks/week1,963 (19.3)0.82 (0.61, 1.09)0.171
 ≥7 drinks/week470 (4.6)1.09 (0.67, 1.78)0.733
 No drinks/week7,725 (76.0)1
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/m2)32.2 ± 5.51.01 (0.99, 1.03)0.382
Systolic blood pressure (mmHg)136.3 ± 17.11.00 (1.00, 1.01)0.365
Diastolic blood pressure (mmHg)74.9 ± 10.60.98 (0.97, 0.99)<0.001
Visual acuity<0.001
 <20/402,310 (23.8)3.22 (2.06, 5.04)<0.001
 20/20–20/405,906 (60.8)1.97 (1.28, 3.04)0.002
 ≥20/201,502 (15.5)1
Peripheral neuropathy (yes vs. no)4,328 (42.7)1.86 (1.49, 2.31)<0.001
Heart rate72.6 ± 11.71.00 (0.99, 1.01)0.847
Q-T index101.7 ± 5.21.06 (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 ± 56.21.00 (1.00, 1.00)0.258
LDL (mg/dL)104.9 ± 33.91.00 (1.00, 1.00)0.515
HDL (mg/dL)41.8 ± 11.60.98 (0.97, 0.99)<0.001
Triglycerides (mg/dL)190.3 ± 148.71.00 (1.00, 1.00)0.928
Serum creatinine (mg/dL)0.9 ± 0.24.04 (2.81, 5.82)<0.001
Urinary albumin-to-creatinine ratio (mg/mg)<0.001
 <306,937 (68.8)1
 30 to ≤3002,481 (24.6)1.96 (1.54, 2.49)<0.001
 >300670 (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 randomization3,927 (38.6)0.78 (0.62, 0.98)0.030
Site size0.978
 <1001,568 (15.4)0.99 (0.72, 1.37)0.969
 100–1503,027 (29.8)1.02 (0.80, 1.31)0.848
 >1505,568 (54.8)1
  • Values are means ± SD or n (%).