Table 1.
Baseline characteristics of the patients.
| Characteristic | NFII group (n=206) | CIP group (n=206) | p-Value |
|---|---|---|---|
| Age, years | 58.43 ± 10⋅05 | 57.41 ± 10.02 | 0.3022 |
| Male sex | 114 (55.34) | 107 (51.94) | 0⋅4892 |
| Body weight, kg | 70.30 ± 11.51 | 69.21 ± 12.09 | 0.2987 |
| BMI, kg/m2 | 25.38 ± 3⋅09 | 25.28 ± 2.84 | 0.7249 |
| SBP, mmHg | 131.08 ± 15.83 | 129.22 ± 15.53 | 0.8606 |
| Diabetes duration, years | 14.44 ± 7.52 | 13.79 ± 6.65 | 0.4299 |
| Insulin-naïve | 11 (5.34) | 10 (4.85) | 0.8228 |
| Initiated basal insulin | 5 | 8 | 0.5733 |
| Initiated premix insulin | 6 | 2 | 0.2834 |
| Using premix insulin during trial: | 118 (57.28) | 109 (52.91) | 0⋅3727 |
| Human insulin (30% or 50%) | 41 (34.75%) | 42 (38.53%) | 0.5830 |
| Insulin analogue (30%, 50% or 25%) | 77 (65.25%) | 67 (61.47%) | 0.5830 |
| Using basal insulin during trial: | 88 (42.72) | 97 (47.09) | 0.3727 |
| Glargine | 64 (72.73%) | 65 (67.01%) | 0.4265 |
| Determir | 15 (17.05%) | 21 (21.65%) | 0.4620 |
| NPH | 9 (10.23%) | 11 (11.34%) | 1.0000 |
| Daily insulin dosage, U/kg: | 0.44 ± 0.05 | 0.44 ± 0.06 | 0.8449 |
| Using premix | 0.54 ± 0.04 | 0.56 ± 0.03 | 0.5523 |
| Initiating premix | 0.55 ± 0.02 | 0.63 ± 0.18 | 0.8358 |
| Using basal | 0.31 ± 0.03 | 0.31 ± 0.05 | 0.8959 |
| Initiating basal | 0.24 ± 0.05 | 0.16 ± 0.00 | 0.4207 |
| HbA1c, % | 8.30 ± 1.01 | 8.19 ± 0.99 | 0.2565 |
| [mmol/mol] | [67.0 ± 11.0] | [66.0 ± 10.8] | |
| FBG, mmol/L | 8.76 ± 2.18 | 8.84 ± 2.35 | 0.7429 |
| BG after breakfast, mmol/L | 12.27 ± 3.20 | 12.19 ± 3.10 | 0.8042 |
| BG before lunch, mmol/L | 9.67 ± 2.88 | 9.90 ± 2.88 | 0.4159 |
| BG after lunch, mmol/L | 12.30 ± 3.08 | 12.35 ± 3.05 | 0.8719 |
| BG before dinner, mmol/L | 9.96 ± 2.78 | 10.⋅03 ± 2.85 | 0.8077 |
| BG after dinner, mmol/L | 11.91 ± 2.98 | 12.09 ± 3.16 | 0.5552 |
| G at bedtime, mmol/L | 10.69 ± 3.03 | 10.81 ± 3.11 | 0.6964 |
| Using metformin | 120 (57.97) | 97 (46.41) | 0.0183 |
| Using sulfonylureas | 33 (15.94) | 36 (17.22) | 0.7251 |
| Using α-glycosidase inhibitors | 100 (48.31) | 101 (48.33) | 0.9974 |
| Using DPP-4 inhibitors | 6 (2.90) | 8 (3.83) | 0.5993 |
| Using GLP-1RAs | 3 (1.45) | 0 (0.00) | 0.1223 |
| Using SGLT2Is | 1 (0.48) | 1 (0.48) | 1.000 |
| Diabetes retinopathy | 4 (1.94) | 1 (0.49) | 0.3719 |
| Diabetes kidney disease | 4 (1.94) | 3 (1.46) | 1.0000 |
| Diabetes neuropathy | 2 (0.97) | 3 (1.46) | 1.0000 |
| Hypertension | 74 (35.92) | 76 (36.89) | 0.8377 |
| Cerebrovascular disease | 3 (1.46) | 5 (2.43) | 0.7239 |
| Cardiovascular disease | 21 (10.19) | 22 (10.68) | 0.8720 |
| Dyslipidemia | 40 (19.42) | 35 (16.99) | 0.5232 |
Data are mean values ± SEM or n (%).
Abbreviations: BG, blood glucose concentration measured by patients themselves; BMI, body mass index; CIP, conventional insulin pen; DDP-4, dipeptidyl peptidase-4; FBG, fasting blood glucose concentration; GLP-1RAs, glucagon-like peptide-1 receptor agonists; NFII, needle-free insulin injector; NPH, neutral protamine Hagedorn; SBP, systolic blood pressure; SGLT2Is, sodium-glucose cotransporter-2 inhibitors.