Table 1.
Demographics and baseline characteristics (all randomized population)
| U‐500R CSII N = 209 | U‐500R MDI N = 211 | |
|---|---|---|
| Sex, male | 104 (49.8) | 117 (55.5) |
| Age, years | 57.6 ± 10.3 | 56.7 ± 10.1 |
| Race | ||
| White | 160 (76.6) | 160 (75.8) |
| Black/African American | 19 (9.1) | 14 (6.6) |
| Multiple | 25 (12.0) | 26 (12.3) |
| Other/missing | 5 (2.4) | 11 (5.2) |
| Hispanic or Latino | 39 (18.7) | 49 (23.2) |
| BMI, kg/m2 | 39.3 ± 5.6 | 40.1 ± 5.8 |
| HbA1c, % | 8.75 ± 1.03 | 8.77 ± 1.08 |
| HbA1c, mmol/mol | 72.1 ± 11.3 | 72.3 ± 11.8 |
| Duration of diabetes, years | 17.4 ± 7.6 | 16.9 ± 7.7 |
| FPG, mg/dL | 165 ± 60 | 165 ± 59 |
| FPG, mmol/L | 9.2 ± 3.3 | 9.2 ± 3.3 |
| Systolic BP, mmHg | 131 ± 17 | 135 ± 18 |
| Diastolic BP, mmHg | 75 ± 9.6 | 77 ± 10.0 |
| TDD insulin, U | 288 ± 108 | 291 ± 93 |
| TDD insulin, U/kg | 2.56 ± 0.91 | 2.54 ± 0.89 |
| U‐500R use at entry | 59 (28.2) | 59 (28.0) |
| Glucose‐lowering medications, alone or in combination | N = 118 | N = 125 |
| DPP‐4 | 10 (8.5) | 10 (8.0) |
| SGLT2i | 25 (21.2) | 24 (19.2) |
| GLP‐1RA | 17 (14.4) | 21 (16.8) |
| Metformin | 99 (83.9) | 103 (82.4) |
| Pioglitazone | 4 (3.4) | 5 (4.0) |
| Bolus dosing option (CSII group) | ||
| Fixed dose | 169 (80.9) | N/A |
| Meal size | 22 (10.5) | N/A |
| CHO counting | 12 (5.7) | N/A |
| Missing | 6 (2.9) | N/A |
Abbreviations: BMI, body mass index; BP, blood pressure; CHO, carbohydrate; CSII, continuous subcutaneous insulin infusion; FPG, fasting plasma glucose; DPP‐4, dipeptidylpeptidase‐4 inhibitor; GLP‐1RA, glucagon‐like peptide‐1 receptor agonist; MDI, multiple daily injection; SGLT2i, sodium glucose co‐transporter‐2 inhibitor.
Data are n (%) or mean ± SD.