Table 1 –
Selected clinical characteristics of participants belonging to subgroups (A1CDCCT/EDIC < 7.5%, A1CDCCT/EDIC ≥ 7.5%) and for the entire cohort.
| Clinical covariates | A1CDCCT/EDIC < 7.5% N = 367 | A1CDCCT/EDIC ≥ 7.5% N = 838 | Entire cohort N = 1205 |
|---|---|---|---|
| Baseline characteristics | |||
| Age (years) | 27 ± 7 | 27 ± 7 | 27 ± 7 |
| Gender-male (%) | 53 | 53 | 53 |
| Group treatment-intensive (%) | 74 | 39 | 50 |
| Diabetes duration (months) | 72 ± 53 | 65 ± 48 | 67 ± 50 |
| Retinopathy (%) | 51 | 49 | 50 |
| Eligibility-HbA1C (%) | 8.4 ± 1.3c (68 ± 14) | 9.3 ± 1.6 (78 ± 17)e | 9.0 ± 1.6 (75 ± 17)e |
| Severe hypoglycemia (%)d | 18 | 20 | 19 |
| Clinical neuropathy (%) | 4 | 7 | 6 |
| Baseline-AER (mg/24 h) | 17 ± 25 | 15 ± 16 | 16 ± 19 |
| Clinical characteristics prior to or at the time of calcification-measure | |||
| Smoking (%) | 9c | 18 | 15 |
| Hyperlipidemia (%) | 29c | 39 | 36 |
| LDL (mg/dl) | 105 ± 25c | 115 ± 30 | 112 ± 29 |
| HDL (mg/dl) | 57 ± 16c | 56 ± 14 | 56 ± 15 |
| Triglycerides (mg/dl) | 80 ± 56c | 94 ± 63 | 90 ± 61 |
| Total cholesterol (mg/dl) | 178 ± 31c | 190 ± 35 | 186 ± 34 |
| Hypertension (%) | 28c | 41 | 37 |
| Systolic blood pressure (mm/Hg) | 120 ± 13c | 123 ± 15 | 122 ± 14 |
| Diastolic blood pressure (mm/Hg) | 75 ± 9b | 77 ± 9 | 76 ± 9 |
| Body Mass Index (kg/m2) | 27 ± 4c | 28 ± 4 | 28 ± 4 |
| AER (mg/24 h) | 20 ± 106c | 162 ± 736 | 119 ± 620 |
| DCCT-follow-up time (years) | 6.5 ± 1.6 | 6.4 ± 1.7 | 6.4 ± 1.7 |
| EDIC-follow-up time (years) | 9.0 ± 0.5 | 9.0 ± 0.5 | 9.0 ± 0.5 |
| Glycemic control and severe hypoglycemia | |||
| Mean DCCT-A1C (%) | 6.9 ± 0.6c (52 ± 7)e | 8.7 ± 1.3 (72 ± 14)f | 8.2 ± 1.4 (66 ± 15)f |
| Mean EDIC-A1C (%) | 7.0 ± 0.6b (53 ± 7)f | 8.5 ± 1.0 (69 ± 11)f | 8.1 ± 1.2 (65 ± 13)f |
| Mean A1CDCCT/EDIC (%) | 7.0 ± 0.4b (53 ± 4)f | 8.6 ± 0.9 (70 ± 10)f | 8.1 ± 1.1 (65 ± 12)f |
| DCCT-severe hypoglycemia rate | 5.0 ± 8.0c | 3.6 ± 8.0 | 4.0 ± 8.0 |
| (#events/10 patient-years)e | |||
| DCCT-RR | 1.74(95%CI:1.36–2.23)c | NA | |
| A1CDCCT/EDIC < vs. A1CDCCT/EDIC ≥ 7.5% | |||
| EDIC-severe hypoglycemia rate | 5.0 ± 9.9a | 3.8 ± 8.3 | 4.2 ± 8.8 |
| (#events/10 patient-years) | |||
| EDIC-RR | 1.33(95%CI:1.03–1.72)a | NA | |
| A1CDCCT/EDIC < vs. A1CDCCT/EDIC ≥ 7.5% | |||
Data are means ± SD unless otherwise indicated.
p < 0.05.
p < 0.01.
p < 0.001 (comparison patient cohorts A1CDCCT/EDIC < 7.5% vs. A1CDCCT/EDIC ≥ 7.5%).
Baseline severe hypoglycemia events reported at initial DCCT-visit for the previous year.
DCCT-rates are based on a follow-up time which represents the time from randomization until last DCCT-visit or HbA1C-closeout visit collection date (whatever date was later). EDIC-rates or events are based on EDIC-follow-up days which mirror: [(days of 3 months) × (number of annual visits)], since hypoglycemia events were only recorded for the 3 months prior to the annual EDIC-visits. The events were confirmed by additional documentation. The mean event rate was calculated according to the following formula: Mean event rate per 10 patient-years = 10 × 365.25 × (Number of events)/(Number of recorded follow-up days).
For the EDIC it represents a projected rate.
SI, IFCC-recommended mmol/mol.