Table 1. Characteristics of the 1211 Patients Evaluated for Retinopathy After 10 Years of EDIC Follow-up.
| DCCT Treatment Group, %a |
|||
|---|---|---|---|
| Characteristic | Conventional (n=615)b | Intensive (n=596)b | P Valuec |
| At DCCT entry | |||
| Women | 49.2 | 50.8 | .30 |
| Age, y, mean (SD) | 27 (7) | 27 (7) | .13 |
| Primary prevention cohortd | 51.2 | 49.2 | .47 |
| Duration of diabetes mellitus, y, mean (SD) | 5.7 (4.1) | 6.0 (4.2) | .27 |
| Glycated hemoglobin level, %, mean (SD) | 9.0 (1.6) | 9.1 (1.6) | .25 |
| At DCCT closeout/EDIC baselinee | |||
| Age, y, mean (SD) | 33 (7) | 34 (7) | .09 |
| Duration of diabetes, y, mean (SD) | 11.8 (4.9) | 12.2 (4.9) | .14 |
| DCCT follow-up, y, mean (SD) | 6.3 (1.6) | 6.4 (1.7) | .32 |
| Glycosylated hemoglobin level, %, mean (SD) | 9.0 (1.3) | 7.3 (0.9) | <.001 |
| Treatment | |||
| Continuous subcutaneous insulin infusion (pump) or multiple daily injections | 5.1 | 98.0 | <.001 |
| Self-monitoring of blood glucose level, ≥4 times/d | 4.1 | 53.7 | <.001 |
| Arterial blood pressure,f mm Hg, mean (SD) | 88.2 (8.7) | 88.7 (8.6) | .30 |
| Hyperlipidemiag | 10.6 | 7.2 | .04 |
| Level of retinopathy | |||
| None (10/10) | 17.8 | 28.5 | <.001 |
| Microaneurysms only (20/[<]20) | 31.7 | 39.8 | |
| Mild nonproliferative retinopathy (35/[<]35) | 27.7 | 21.5 | |
| Moderate or severe nonproliferative retinopathy (43/[<]43) | 22.8 | 10.2 | |
| Photocoagulation during DCCT | |||
| Scatter, for retinopathy | 4.1 | 1.7 | .01 |
| Focal, for macular edema | 5.4 | 2.2 | .004 |
| Treatment at EDIC year 10 | |||
| Continuous subcutaneous insulin infusion (pump) or multiple daily injections | 92.2 | 96.6 | .001 |
| Self-monitoring of blood glucose level, ≥4 times/d | 61.5 | 53.7 | .007 |
Abbreviations: DCCT, Diabetes Control and Complications Trial; EDIC, Epidemiology of Diabetes Interventions and Complications.
SI conversion factors: To convert low-density lipoprotein cholesterol to micromoles per liter, multiply by 0.0259; triglycerides to micromoles per liter, multiply by 0.0113; hemoglobin to proportion of total hemoglobin, multiply by 0.01.
Unless otherwise indicated.
The numbers of patients who were alive, had gradable fundus photographs at EDIC year 10, or underwent scatter photocoagulation in one or both eyes during EDIC are included.
P values were based on the Wilcoxon rank sum test for quantitative or ordinal variables or the χ2 test for categorical variables.
No retinopathy or microalbuminuria at baseline (see “Methods” section of the text).
The baseline data in the EDIC study were the same as the data at the end of the DCCT.
Arterial blood pressure=2/3 diastolic blood pressure + 1/3 systolic blood pressure.
Hyperlipidemia is defined as 2 consecutive reports of hypercholesterolemia (low-density lipoprotein cholesterol level >160 mg/dL) or hypertriglyceridemia (triglyceride level >500 mg/dL) within 1 month during DCCT.