HI/NPH n=1.984 | BIA n=1.852 | P value | |
HbA1c, % | 7.3 (7.25 to 7.36) | 7.4 (7.32 to 7.42) | 0.057 |
HbA1c, mmol/mol | 56.3 (55.7 to 56.9) | 57.1 (56.5 to 57.7) | 0.057 |
Fasting blood glucose, mmol/L | 8.4 (8.2 to 8.6) | 8.4 (8.3 to 8.6) | 0.849 |
Total daily insulin dose, IU/kg/day | 0.296 (0.281 to 0.311) | 0.239 (0.224 to 0.254) | <0.001 |
Prandial to total insulin ratio, % | 70.07 (71.59 to 98.52) | 82.76 (39.63 to 74.17) | <0.001 |
Hospitalization per patient-year, n | 0.8 (0.7 to 0.9) | 0.7 (0.7 to 0.8) | 0.145 |
Length of stay per patient-year, days | 16.1 (15.7 to 16.5) | 16.3 (15.8 to 16.7) | 0.533 |
<HbA1c median and no severe hypoglycemia* or hypoglycemia with coma†, % of patients | 48.6 | 51.5 | 0.086 |
Severe hypoglycemia* | |||
Patients with events, % | 2.8 | 2.4 | |
Rate per 100 patient-years | 4.40 (2.2 to 8.8) | 4.07 (2.0 to 8.8) | 0.881 |
Hypoglycemic coma† | |||
Patients with events, % | 2.8 | 3.0 | |
Rate per 100 patient-years | 3.26 (1.2 to 9.0) | 3.64 (1.2 to 10.8) | 0.885 |
Diabetic ketoacidosis‡ | |||
Patients with events, % | 0.3 | 0.1 | |
Rate per 100 patient-years | 0.28 (0.02 to 3.37) | 0.05 (0.04 to 0.7) | 0.363 |
Data shown as LS mean (95% CI).
Bold numbers indicate p-values <0.05.
*Defined as an event requiring assistance by another person to actively administer carbohydrates, glucagon or other resuscitative actions.
†Defined as loss of consciousness or occurrence of seizures.
‡Defined as pH <7.3 and/or bicarbonate <15 mmol/mol or hospitalization for diabetic ketoacidosis.
BIA, basal insulin analogs; HbA1c, hemoglobin A1c; HI, human insulin; IU, international unit; LS, least squares means; NPH, neutral protamine Hagedorn.