Introduction
Methods
Data Sources
Compliance with Ethics Guidelines
Study Population
Definition of Key Measurements and Main Outcomes
Prevalence of High-Dose Insulin Users
Incidence of High-Dose Insulin Initiation
Statistical Analyses
Results
Baseline Characteristics of HDIU
Measurement | Type 1 | Type 2 | ||
---|---|---|---|---|
Low-dose | High-dose | Low-dose | High-dose | |
N = 5596 | N = 247 | N = 8105 | N = 443 | |
Age, mean (SD) | 37.3 (20.6) | 39.1 (19.5) | 64.5 (13.9) | 63.5 (11.9) |
Male, N (%) | 3109 (55.6%) | 157 (63.6%)* | 4459 (55.0%) | 267 (60.3%)* |
Region (%) | ||||
England | 4193 (74.9%) | 186 (75.3%) * | 6243 (77.0%) | 350 (79.0%) |
Northern Ireland | 279 (5.0%) | 21 (8.5%) | 401 (4.9%) | 27 (6.1%) |
Scotland | 714 (12.8%) | 15 (6.1%) | 847 (10.5%) | 38 (8.6%) |
Wales | 410 (7.3%) | 25 (10.1%) | 614 (7.6%) | 28 (6.3%) |
Years since diagnosis, mean (SD) | 11.7 (12.6) | 14.3 (11.8)* | 11.2 (8.6) | 13.3 (7.4)* |
Weight (kg), mean (SD) | 71.8 (21.8) | 90.3 (27.2)* | 89.2 (20.6) | 106.2 (23.6)* |
BMI kg/m2, mean (SD) | 25.6 (5.8) | 30.4 (7.9)* | 31.4 (6.7) | 36.8 (7.3)* |
HbA1c, mean (SD) | 8.9 (2.0) | 8.7 (1.7) | 9.0 (1.9) | 9.0 (1.7) |
HbA1c ≥ 9% | 1220 (40.4%) | 55 (38.7%) | 2519 (43.0%) | 139 (41.9%) |
Oral, N (%) | 639 (11.4%) | 50 (20.2%)* | 5658 (69.8%) | 291 (65.7%) |
GLP-1, N (%) | 29 (0.5%) | 4 (1.6%)*a | 642 (7.9%) | 61 (13.8%)* |
Antihypertensive treatment, N (%) | 2197 (39.3%) | 141 (57.1%)* | 6668 (82.3%) | 423 (95.5%)* |
Lipid-lowering treatment, N (%) | 1747 (31.2%) | 114 (46.2%)* | 6059 (74.8%) | 376 (84.9%)* |
Antiplatelet treatment, N (%) | 1011 (18.1%) | 70 (28.3%)* | 4061 (50.1%) | 279 (63.0%)* |
eGFR (mL/min per 1.73 m2) | 93.5 (33.09) | 85.9 (32.57) | 69.2 (28.35) | 68.3 (28.82) |
Charlson comorbidity index | 0.5 (0.76) | 0.5 (0.77) | 0.7 (0.91) | 0.7 (0.94) |
Treatment Outcomes of HDII in 2013
Measurement | Type 1 | Type 2 | ||
---|---|---|---|---|
6 months prior | 6 months post | 6 months prior | 6 months post | |
N = 170 | N = 170 | N = 245 | N = 245 | |
Insulin regimen | 167 (98.2%) | 170 (100.0%) | 242 (98.8%) | 245 (100.0%) |
Analogue insulin | 160 (94.1%) | 165 (97.1%) | 205 (83.7%) | 210 (85.7%) |
Analogue basal | 126 (74.1%) | 131 (77.1%) | 127 (51.8%) | 134 (54.7%) |
Analogue mixture | 18 (10.6%) | 17 (10.0%) | 73 (29.8%) | 70 (28.6%) |
Analogue fast-acting | 146 (85.9%) | 154 (90.6%) | 121 (49.4%) | 128 (52.2%) |
Basal: bolus dosage (insulin) | 39:61 | 39:61 | 63:37 | 63:37 |
Basal: bolus dosage (analogue insulin) | 37:63 | 36:64 | 60:40 | 61:39 |
HbA1c, mean (SD) | 8.7 (1.59) | 8.6 (1.67) | 9.1 (1.81) | 8.6 (1.78)* |
8% ≤ HbA1c < 9%, N (%) | 24 (26.1%) | 17 (21.8%) | 44 (22.9%) | 42 (23.0%) |
HbA1c ≥ 9%, N (%) | 36 (39.1%) | 27 (34.6%) | 88 (45.8%) | 63 (34.4%)* |
Other glucose-lowering therapy, N (%) | ||||
Oral class | 24 (14.1%) | 27 (15.9%) | 165 (67.3%) | 155 (63.3%) |
Metformin | 23 (13.5%) | 26 (15.3%) | 146 (59.6%) | 136 (55.5%) |
Sulfonylurea | 0 | 0 | 39 (15.9%) | 28 (11.4%) |
Thiazolidinediones | 0 | 0 | 4 (1.6%) | 3 (1.2%) |
DPP-4 inhibitors | 3 (1.8%) | 3 (1.8%) | 25 (10.2%) | 23 (9.4%) |
GLP-1 | 2 (1.2%) | 3 (1.8%) | 36 (14.7%) | 26 (10.6%) |
eGFR, mean (SD) | 90.3 (31.5) | 88.7 (40.2) | 70.2 (27.9) | 67.0 (26.8)* |
Trend of Characteristics of HDII
Measurement | Type 1 | Type 2 | ||||
---|---|---|---|---|---|---|
2009 | 2011 | 2013 | 2009 | 2011 | 2013 | |
N = 95 | N = 128 | N = 170 | N = 194 | N = 245 | N = 245 | |
Annualized incidence rate (per 1000 PYAR) | 28.19 (22.52, 33.86) | 27.21 (22.49, 31.91) | 31.60 (26.85, 36.35) | 40.36 (34.68, 46.04) | 36.27 (31.73, 40.81) | 31.34 (27.41,35.26) |
Age, mean (SD) | 44.0 (20.9) | 38.9 (18.4) | 35.5 (19.3) | 62.9 (12.1) | 62.5 (12.8) | 62.9 (12.7) |
Male | 57 (60.0%) | 76 (59.4%) | 106 (62.4%) | 116 (59.8%) | 136 (55.5%) | 138 (56.3%) |
Duration of diabetes | 14.0 (12.3) | 14.3 (10.8) | 13.0 (11.3) | 12.2 (7.1) | 13.3 (7.7) | 12.4 (7.4) |
Region | ||||||
England | 75 (78.9%) | 97 (75.8%) | 124 (72.9%) | 161 (83.0%) | 205 (83.7%) | 198 (80.8%) |
Northern Ireland | 8 (8.4%) | 14 (10.9%) | 12 (7.1%) | 9 (4.6%) | 7 (2.9%) | 16 (6.5%) |
Scotland | 8 (8.4%) | 8 (6.3%) | 14 (8.2%) | 16 (8.2%) | 20 (8.2%) | 14 (5.7%) |
Wales | 4 (4.2%) | 9 (7.0%) | 20 (11.8%) | 8 (4.1%) | 13 (5.3%) | 17 (6.9%) |
Weight | 90.1 (25.45) | 85.5 (22.54) | 84.2 (21.90) | 104.6 (23.55) | 100.4 (21.78) | 102.5 (22.76) |
BMI | 31.2 (7.78) | 29.9 (6.62) | 29.0 (7.19) | 35.7 (6.71) | 35.7 (6.98) | 35.9 (7.63) |
BMI < 30 | 21 (41.2%) | 32 (52.5%) | 49 (59.8%) | 24 (17.6%) | 25 (15.7%) | 29 (18.4%) |
30 ≤ BMI < 35 | 16 (31.4%) | 15 (24.6%) | 17 (20.7%) | 43 (31.6%) | 56 (35.2%) | 49 (31.0%) |
35 ≤ BMI < 40 | 10 (19.6%) | 9 (14.8%) | 9 (11.0%) | 40 (29.4%) | 42 (26.4%) | 37 (23.4%) |
BMI ≥ 40 | 4 (7.8%) | 5 (8.2%) | 7 (8.5%) | 29 (21.3%) | 36 (22.6%) | 43 (27.2%) |
Antihypertensive treatments | 55 (57.9%) | 70 (54.7%) | 84 (49.4%) | 188 (96.9%) | 228 (93.1%) | 233 (95.1%) |
Antiplatelet treatments | 36 (37.9%) | 27 (21.1%) | 36 (21.2%) | 132 (68.0%) | 155 (63.3%) | 158 (64.5%) |
Lipid-lowering treatments | 47 (49.5%) | 59 (46.1%) | 59 (34.7%) | 162 (83.5%) | 210 (85.7%) | 205 (83.7%) |
Factors Associated with High-Dose Insulin Initiation
Variablesa | Type 1 | Type 2 | ||
---|---|---|---|---|
RR (95% CI) | P value | RR (95% CI) | P value | |
BMI | 1.1 (1.12,1.17) | < 0.001 | 1.1 (1.10, 1.13) | < 0.001 |
Year: 2011 vs 2009 | 1.0 (0.71, 1.45) | 0.923 | 0.8 (0.65, 1.08) | 0.176 |
Year: 2013 vs 2009 | 1.5 (1.13, 2.12) | 0.007 | 0.8 (0.62, 0.97) | 0.025 |
Antihypertensive treatment | 1.2 (0.95, 1.61) | 0.123 | 2.8 (1.91, 4.20) | < 0.001 |
Region | ||||
Northern Ireland vs England | 2.2 (1.35, 3.47) | 0.001 | ||
Scotland vs England | 0.5 (0.33, 0.81) | 0.004 | ||
Wales vs England | 1.8 (1.19, 2.80) | 0.006 | ||
Female vs male | 0.7 (0.58, 0.95) | 0.017 | ||
Antiplatelet | 1.4 (1.13, 1.65) | 0.001 | ||
Lipid-lowering treatment | 1.2 (0.93, 1.56) | 0.151 | ||
Duration of diabetes | 1.0 (1.004, 1.024) | 0.006 |