Hypoglycemia event rate per person week based on 7-point profiles defined by level for ITT population
| Variable | HRI | RAI | P value |
| n=69 | n=67 | ||
| Event rate/person week level 1 | |||
| Prerandomization, 7-point | 0.054 | 0.057 | |
| Postrandomization, 7-point | 0.009 | 0.017 | |
| IRR HRI/RAI (net post/pre)* | 0.565 (0.185 to 1.720) | 0.315 | |
| Event rate/person week level 2 | |||
| Prerandomization, 7-point | 0.023 | 0.008 | |
| Postrandomization, 7-point | 0.009 | 0.000 | |
| IRR HRI/RAI (net post/pre)* | Undefined | ||
| Event rate/person week any level | |||
| Prerandomization, 7-point | 0.069 | 0.065 | |
| Postrandomization, 7-point | 0.016 | 0.017 | |
| IRR HRI/RAI (net post/pre)* | 0.925 (0.386 to 2.217) | 0.861 | |
*IRR quantitates the risk of hypoglycemia in the HRI group compared with the RAI group. IRR <1.0 favors the HRI group and an IRR >1.0 favors the RAI group. Between-group difference results from Poisson regression model with repeated measures; generalized estimating equations approach. Level 1 (≤70 mg/dL or (<3.9 mmol/L)) and level 2 hypoglycemia (<54 mg/dL (<3.0 mmol/L)). No level 3 events were reported for either group.
HRI, human regular insulin; IRR, incident rate ratio; ITT, intent-to-treat; RAI, rapid acting insulin.