Table 1:
Candidate risk factors and their univariate relationship with the outcome variable time to SH. HR=hazard ratio; CI=confident interval; Only risk factors that are univariately significantly associated with time to SH are shown (48 out of 91). See supplemental table 1 for all candidate risk factors.
| Variable Name | Description | measurement time | Univariate Relationship with SH | |||
|---|---|---|---|---|---|---|
| HR | CI (95%) | P- Value |
||||
| Glycemia | Glycemia Trial Status: 1=active, 0=inactive | every 2 weeks in the first three month; monthly afterwards | 2.83 | 1.51 | 5.29 | 0.001 |
| Intensive Tx | Intensive Hypoglycemia treatment | baseline | 2.52 | 2.15 | 2.96 | <0.001 |
| Black | Black Race | baseline | 1.81 | 1.54 | 2.13 | <0.001 |
| White | White Race | baseline | 0.79 | 0.68 | 0.92 | 0.002 |
| Age | Age (yrs) at Randomization | baseline | 1.05 | 1.04 | 1.06 | <0.001 |
| Education | Highest level of education | baseline | 0.79 | 0.74 | 0.85 | <0.001 |
| DBP | Diastolic Blood Pressure (mmHg) | Monthly in the 1st four month; every two month afterwards | 0.96 | 0.96 | 0.97 | <0.001 |
| Serum Creatinine | Serum creatinine (mg/dL) | quarterly | 1.93 | 1.76 | 2.12 | <0.001 |
| eGFR | eGFR from 4 variable MDRD equation (ml/min/1.73 m2) | quarterly | 0.98 | 0.98 | 0.98 | <0.001 |
| Urine Protein | Urinary albumin to creatinine ratio (mg/g) | every two years | 1 | 1 | 1 | <0.001 |
| CVD History | CVD History at Baseline: 0=No, 1=Yes | baseline | 1.31 | 1.13 | 1.52 | <0.001 |
| Ulcer | foot ulcer requiring antibiotics | baseline | 0.63 | 0.47 | 0.84 | 0.002 |
| UACR | protein in urine | baseline | 0.81 | 0.68 | 0.96 | 0.016 |
| Years Diab | year of diabetes diagnosis | baseline | 1.06 | 1.05 | 1.06 | <0.001 |
| # Recent Hypoglycemia |
# of hypoglycemic episodes (SMBG <70 mg/dL or <3.9mmol/L) in last 7d | monthly | 1.34 | 1.29 | 1.38 | <0.001 |
| Visual Acuity (R) | visual acuity score, right eye | baseline | 0.99 | 0.99 | 0.99 | <0.001 |
| Visual Acuity (L) | visual acuity score, left eye | baseline | 0.99 | 0.98 | 0.99 | <0.001 |
| Retinopathy | participant had retinopathy | annually | 0.48 | 0.39 | 0.59 | <0.001 |
| Vision Loss | vision loss | annually | 0.62 | 0.5 | 0.76 | <0.001 |
| Ankle Reflexes | ankle reflexes | annually | 1.31 | 1.12 | 1.54 | 0.001 |
| # hypoglycemia hospitalization | hypoglycemia requiring hospitalization, emergency care without hospital admission, or medical assistance without emergency care or hospitalization, number of times since last call | monthly | 15.4 | 10.9 | 22 | <0.001 |
| HUI3 | Health Utilities Index Mark3 (HUI3); | baseline; 12m; 36m; 48m and Exit visit | 0.48 | 0.37 | 0.62 | <0.001 |
| HUI2 | Health Utilities Index Mark2 (HUI2); | baseline; 12m; 36m; 48m and Exit visit | 0.4 | 0.27 | 0.6 | <0.001 |
| Loop | Loop diuretics | annually | 2.12 | 1.78 | 2.53 | <0.001 |
| Thiazide | Thiazide diuretics | annually | 1.25 | 1.08 | 1.45 | 0.003 |
| Ksparing | Ksparing diuretics | annually | 1.54 | 1.1 | 2.15 | 0.012 |
| Potassium | Potassium supplements | annually | 1.19 | 1.03 | 1.38 | 0.022 |
| Ace Inibitos | Ace inhibitors | annually | 1.18 | 1.02 | 1.37 | 0.025 |
| DHP CCD | Dihydropyridine calcium channel blockers | annually | 1.34 | 1.08 | 1.66 | 0.008 |
| Alpha-Blocker | Peripheral alpha-blockers | annually | 1.45 | 1.08 | 1.96 | 0.014 |
| Beta-Blocker | Beta-blockers | annually | 1.48 | 1.27 | 1.71 | <0.001 |
| Antiarrhythmic | Anti-arrhythmics | annually | 1.96 | 1.05 | 3.65 | 0.035 |
| Nitrates | Nitrates | annually | 1.4 | 1.05 | 1.86 | 0.02 |
| Other CV Meds | Other cardiovascular drugs | annually | 1.94 | 1.07 | 3.51 | 0.03 |
| Sulfonylurea | Sulfonylureas | annually | 0.6 | 0.52 | 0.7 | <0.001 |
| Biguanide | Biguanides | annually | 0.58 | 0.5 | 0.67 | <0.001 |
| Meglitinide | Meglitinides | annually | 1.36 | 1.11 | 1.67 | 0.003 |
| NPH/L Insulins | NPH or L Insulins | annually | 3.49 | 2.94 | 4.14 | <0.001 |
| TZD | Thiazolidinediones | annually | 1.43 | 1.23 | 1.66 | <0.001 |
| Reg Insulin | Regular Insulins | annually | 2.52 | 1.95 | 3.26 | <0.001 |
| Lisprot/Aspart Insulin |
Lispro or Aspart Insulins | annually | 2.43 | 2.08 | 2.84 | <0.001 |
| Other Bolus Insulin |
Other Bolus Insulins | annually | 0.23 | 0.07 | 0.77 | 0.018 |
| Premixed Insulins | Premixed Insulins | annually | 1.56 | 1.31 | 1.86 | <0.001 |
| Anti Coag | Oral anitcoagulants (warfarin, coumadin, anisindione) | annually | 1.44 | 1.04 | 2 | 0.029 |
| Platelet Agi | Inhibitors of platelet aggregations (except aspirin) | annually | 1.35 | 1.03 | 1.76 | 0.029 |
| Thyroid | Thyroid agents | annually | 1.35 | 1.07 | 1.72 | 0.013 |
| Fluid Retention | Diuretic for fluid retention | annually | 2.58 | 1.22 | 5.44 | 0.013 |
| Other Meds | Any other prescribed medication | annually | 1.4 | 1.21 | 1.62 | <0.001 |