Composite end point | No composite end point | P value | PRP | No PRP | P value | Worsening retinopathy | No worsening retinopathy | P value | New retinopathy | No new retinopathy | P value | |
N=34 | N=507 | N=27 | N=514 | N=59 | N=482 | N=48 | N=218 | |||||
Male gender | 22/34 (64.7%) | 255/507 (50.3%) | 0.104 | 18/27 (66.7%) | 259/514 (50.4%) | 0.099 | 33/59 (55.9%) | 244/482 (50.6%) | 0.441 | 25/48 (52.1%) | 106/218 (48.6%) | 0.664 |
Age (years) | 45 (35–57) | 46 (34–57) | 0.501 | 44 (34–56) | 46 (34–58) | 0.873 | 48 (35–60) | 46 (34–57) | 0.342 | 47 (35–59) | 45 (30–58) | 0.403 |
Age at diagnosis (years) | 13 (8–21) | 19 (12–31) | 0.01 | 13 (8–21) | 19 (12–22) | 0.004 | 18 (12–31) | 19 (11–30) | 0.946 | 19 (12–31) | 23 (14–37) | 0.195 |
Diabetes duration (years) | 27 (24–38) | 23 (12–36) | 0.001 | 27 (22–36) | 23 (13–34) | 0.009 | 25 (15–35) | 23 (13–34) | 0.302 | 24 (14–33) | 14 (8–30) | <0.001 |
Baseline HbA1c (mmol/mol/%) | 74 (57–81) | 63 (55–71) | 0.006 | 75 (59–82) | 63 (55–71) | 0.005 | 69 (48–81) | 63 (55–71) | 0.01 | 65 (57–73) | 61 (54–68) | 0.014 |
8.9 (7.4–9.6) | 7.9 (7.2–8.6) | 9.0 (7.5–9.7) | 7.9 (7.2–8.6) | 8.5 (6.5–9.6) | 7.9 (7.2–8.6) | 8.1 (7.4–8.8) | 7.7 (7.1–8.4) | |||||
Change in HbA1c (mmol/mol/%) | −5 (-17–-1) | −4 (−9–1) | 0.163 | −4 (−15–0) | −4 (−9–1) | 0.548 | −4 (−12–0) | −4 (−9–1) | 0.226 | −4 (−7–0) | −3 (−9–2) | 0.176 |
−0.5 (−1.6–0.1) | −0.4 (−0.8–0.1) | −0.4 (−1.4–0) | −0.4 (−0.8–0.1) | −0.4 (−1.1–0) | −0.4 (-0.8–0.1) | −0.4 (−0.6–0) | −0.3 (−0.8–0.2) | |||||
HbA1c fall 10 mmol/mol (0.9%) | 12/34 (35.3%) | 123/507 (24.3%) | 0.15 | 9/27 (33.3%) | 126/514 (24.5%) | 0.302 | 21/59 (35.6%) | 114/482 (23.7%) | 0.045 | 15/63 (23.8%) | 48/218 (22.0%) | 0.173 |
CSII | 12/34 (35.3%) | 135/507 (26.6%) | 0.271 | 10/27 (37.0%) | 137/514 (26.7%) | 0.237 | 17/42 (28.8%) | 130/482 (27.0%) | 0.763 | 16/48 (33.3%) | 57/218 (26.1%) | 0.312 |
Baseline retinopathy | 30/34 (88.2%) | 245/507 (48.3) | <0.001 | 25/27 (92.6%) | 250/514 (48.6%) | <0.001 | 11/59 (18.6%) | 264/482 (54.8%) | <0.001 | NA | NA | NA |
Baseline maculopathy | 25/34 (73.5%) | 70/507 (13.8%) | <0.001 | 18/27 (66.7%) | 77/514 (15.0%) | <0.001 | 10/59 (16.9%) | 85/482 (17.6%) | 0.896 | NA | NA | NA |
PRP at baseline | 23/34 (67.6%) | 34/507 (6.7%) | <0.001 | 20/27 (74.1%) | 37/514 (7.2%) | <0.001 | 4/59 (6.8%) | 53/482 (11.0%) | 0.319 | NA | NA | NA |
Macular laser at baseline | 10/34 (29.4%) | 18/507 (3.6%) | <0.001 | 5/27 (18.5%) | 23/514 (4.5%) | 0.001 | 4/59 (6.8%) | 24/482 (5.0%) | 0.781 | NA | NA | NA |
Anti-VEGF at baseline | 6/34 (17.6%) | 2/507 (0.4%) | <0.001 | 3/27 (11.1%) | 5/514 (1.0%) | <0.001 | 2/59 (3.4%) | 6/482 (1.2%) | 0.473 | NA | NA | NA |
Composite at baseline | 26/34 (76.5%) | 44/507 (8.7%) | <0.001 | 20/27 (74.1%) | 50/514 (9.7%) | <0.001 | 8/59 (13.6%) | 62/482 (12.9%) | 0.88 | NA | NA | NA |
Smoking status | C 3/29 (10.3%) | C 49/472 (10.4%) | 0.991 | C 3/23 (13.0%) | C 49/478 (10.3%) | 0.87 | C 1/55 (1.8%) | C 51/446 (11.4%) | 0.084 | C 1/45 (2.2%) | C 19/200 (9.5%) | 0.264 |
E 7/29 (24.1%) | E 119/472 (25.2%) | E 5/23 (21.7%) | E 121/478 (25.3%) | E 16/55 (29.1%) | E 110/446 (24.7%) | E 13/45 (28.9%) | E 50/200 (25.0%) | |||||
N 19/29 (65.5%) | N 304/472 (64.4%) | N 15/23 (65.2%) | N 308/478 (64.4%) | N 38/55 (69.1%) | N 285/446 (63.9%) | N 31 (68.9%) | N 131/200 (65.5%) | |||||
Albumin status | Macro 0/28 (0.0%) | Macro 17/450 (3.8%) | 0.783 | Macro 0/22 (0.0%) | Macro 17/456 (3.7%) | 0.568 | Macro 5/51 (9.8%) | Macro 12/427 (2.8%) | 0.037 | Macro 8/192 (4.2%) | Macro 5/41 (12.2%) | 0.126 |
Micro 2/28 (6.1%) | Micro 32/450 (7.1%) | Micro 1/22 (4.5%) | Micro 33/456 (7.2%) | Micro 4/51 (8.2%) | Micro 30/427 (7.0%) | Micro 11/192 (5.7%) | Micro 2/41 (4.9%) | |||||
None 26/28 (92.9%) | None 401/450 (89.1%) | None 21/22 (95.5%) | None 406/456 (89.0%) | None 42/51 (82.4%) | None 385/427 (90.2%) | None 173/192 (90.1%) | None 34/41 (82.9%) |
C, current; CSII, continuous subcutaneous insulin infusion; E, ex-smoker; HbA1c, glycated hemoglobin; HbA1c, glycated hemoglobin; N, never smoked; PRP, panretinal photocoagulation; VEGF, vascular endothelial growth factor.