Severe hypoglycemic event . | INPUT (n = 128) . | Control group (n = 126) . | IRR (95% CI) . | P value . |
---|---|---|---|---|
All events: third-party assistance + medical intervention | ||||
Number of events (rate per patient-year) | 11 (0.17) | 44 (0.70) | 3.55 (1.50–8.43) | 0.0041* |
Number of affected participants (%) | 6 (4.7) | 9 (7.1) | 0.44+ | |
Third-party assistance without medical intervention | ||||
Number of events (rate per patient-year) | 11 (0.17) | 35 (0.56) | 4.26 (1.77–10.23) | 0.0012* |
Number of affected participants (%) | 6 (4.7) | 6 (4.8) | 1.00+ | |
Only medical intervention | ||||
Number of events (rate per patient-year) | 0 (0.0) | 9 (0.14) | 12.548# | 0.0004# |
Number of affected participants (%) | 0 (0.0) | 6 (4.8) | 0.0144+ |
Severe hypoglycemic event . | INPUT (n = 128) . | Control group (n = 126) . | IRR (95% CI) . | P value . |
---|---|---|---|---|
All events: third-party assistance + medical intervention | ||||
Number of events (rate per patient-year) | 11 (0.17) | 44 (0.70) | 3.55 (1.50–8.43) | 0.0041* |
Number of affected participants (%) | 6 (4.7) | 9 (7.1) | 0.44+ | |
Third-party assistance without medical intervention | ||||
Number of events (rate per patient-year) | 11 (0.17) | 35 (0.56) | 4.26 (1.77–10.23) | 0.0012* |
Number of affected participants (%) | 6 (4.7) | 6 (4.8) | 1.00+ | |
Only medical intervention | ||||
Number of events (rate per patient-year) | 0 (0.0) | 9 (0.14) | 12.548# | 0.0004# |
Number of affected participants (%) | 0 (0.0) | 6 (4.8) | 0.0144+ |
*Zero-inflated Poisson regression for IRR.
+Fisher exact test for comparison of the difference in affected participants.
#Likelihood ratio χ2 derived from omnibus test (IRR not applicable because of zero events in the INPUT group).