Table 1.
Clinical Characteristics of the 1184 Participants with Visual QOL Evaluation during EDIC Years 17-20
| DCCT Baseline (1983-1989) | EDIC Years 17-20 (2011-2014) | ||||
|---|---|---|---|---|---|
| INT(n=605) | CONV(n=579) | INT(n=605) | CONV(n=579) | P value | |
| Age (yr) | 27.5 (7.1) | 26.7 (7.0) | 52.8 (6.9) | 51.8 (6.9) | 0.0236 |
| Female (%) | 49.8 | 46.1 | 49.8 | 46.1 | 0.2104 |
| Primary Prevention Cohort (%) | 47.4 | 50.6 | 47.4 | 50.6 | 0.2759 |
| Duration of Diabetes (yr) | 6.1 (4.3) | 5.7 (4.1) | 30.5 (5.0) | 29.9 (5.0) | 0.0725 |
| Unemployed/Retired (%) | 1.3 | 0.5 | 14.4 | 11.6 | 0.1510 |
| Married (%) | 49.3 | 51.1 | 72.7 | 73.1 | 0.8985 |
| College or Above Education (%) | 73.6 | 73.1 | 90.1 | 90.2 | 0.9665 |
| Smoking (%) | 19.2 | 18.7 | 10.9 | 11.2 | 0.8619 |
| Mean Arterial Pressure (mm Hg) * | 86.0 (8.8) | 86.8 (8.7) | 87.6 (9.9) | 87.1 (9.3) | 0.3567 |
| Hypertension (%) † | 3.3 | 3.1 | 65.0 | 69.1 | 0.1313 |
| Diabetes QOL ‡ | 1.9 (0.3) | 1.9 (0.3) | 75.1 (10.8) | 74.5 (10.4) | 0.2333 |
| Depression or Psychiatric Event (%) § | - | - | 28.2 | 27.6 | 0.8444 |
| Eye Complications: | |||||
| Retinopathy (%) | <0.0001 | ||||
| No Retinopathy (10/10) | 47.5 | 50.6 | 10.7 | 5.2 | |
| MA Only (20/(<)20) | 35.8 | 29.5 | 38.7 | 26.1 | |
| Mild NPDR (35/(<)35) | 12.3 | 14.9 | 22.0 | 24.2 | |
| Moderate or Severe NPDR (43/<44 +) | 4.5 | 5.0 | 17.9 | 19.7 | |
| PDR or Worse (61/<61 +) | 0 | 0 | 10.7 | 24.9 | |
| CSME (%) | 0 | 0 | 16.4 | 25.2 | 0.0002 |
| Visual Acuity in the Worse Eye (%) | 0.0483 | ||||
| ≤20/20 | 85.1 | 85.2 | 60.3 | 53.9 | |
| >20/20 - < 20/40 | 14.9 | 14.9 | 34.7 | 38.5 | |
| 20/40 - < 20/100 | 0 | 0 | 3.0 | 5.5 | |
| ≥20/100 | 0 | 0 | 2.0 | 2.1 | |
| Visual Acuity in the Better Eye (%) | 0.0490 | ||||
| ≤20/20 | 95.9 | 96.7 | 81.3 | 76.2 | |
| >20/20 - < 20/40 | 4.1 | 3.3 | 17.9 | 21.9 | |
| 20/40 - < 20/100 | 0 | 0 | 0.5 | 1.7 | |
| ≥20/100 | 0 | 0 | 0.3 | 0.2 | |
| Any Prior Ocular Surgeries in DCCT/EDIC (%) ∥ | 0 | 0 | 8.6 | 14.9 | 0.0008 |
| Renal Complications: | |||||
| Any AER>300 ug/24hr or Sustained CKD GFR<60 mL/min/1.73 m (%) | 0 | 0 | 8.4 | 16.6 | <0.0001 |
| Any Sustained AER>30 ug/24hr or CKD GFR<60 mL/min/1.73 m (%) | 5.3 | 3.5 | 27.3 | 36.8 | 0.0004 |
| Neuropathy Complications: | |||||
| Abnormal Autonomic Response (%) | 3.8 | 5.4 | 35.3 | 40.2 | 0.0872 |
| Confirmed Clinical Neuropathy (%) | 7.0 | 5.4 | 23.6 | 32.8 | 0.0004 |
| Glycemic Control: | |||||
| HbA1c (%) | 9.0 (1.6) | 8.9 (1.6) | 8.0 (1.2) | 7.9 (1.2) | 0.3345 |
| DCCT Mean HbA1c (%) ** | - | - | 7.2 (0.8) | 9.0 (1.2) | <0.0001 |
| EDIC Mean HbA1c (%) ** | - | - | 8.0 (1.0) | 8.0 (1.0) | 0.5891 |
Data are means (standard deviation) or percent. There were not significant treatment group differences (p<0.05) at DCCT baseline with the exception of a marginally significant difference in age.
Mean arterial pressure was defined as 1/3 systolic blood pressure + 2/3 diastolic blood pressure.
Hypertension was defined by a systolic blood pressure of at least 140 mmHg, a diastolic blood pressure of at least 90 mmHg, documented hypertension, or the use of antihypertensive agents. Medication data was not collected during the DCCT.
Diabetes QOL is a self-administered multiple-choice 46-item assessment assessing different aspects of quality of life employed by DCCT.
Depression or psychiatric event is defined as at least one occurrence of nervousness or anxiety, affective disorder, suicide attempt in EDIC accompanied by hospitalization or out-patient treatment including tranquilizers.
Other ocular surgery includes glaucoma-related surgeries, corneal-related surgeries, YAG capsulotomy, and eye enucleation.
DCCT or EDIC mean hemoglobin HbA1c values are time-averaged throughout the DCCT or EDIC.
- Data not available or not applicable.