1. Overview of study populations.
Intervention(s) and comparator(s) | Sample sizea | Screened/eligible [N] | Randomised [N] | Analysed [N] | Finishing trial [N] | Randomised finishing trial [%] | Follow‐up timeb | |
Umpierrez 2004a | I: s.c. insulin lispro | Arbitrary estimation of a difference between groups of ≥ 5 hours to determine ketoacidosis as being clinically important; a sample size of 20 participants was needed in each group to provide a power of 0.93, given an alpha level of 0.05, a SD of 4, and a 1:1 inclusion ratio | ‐ | 20 | 20 | 20 | 100 | Mean hospital stay: 4 days |
C: i.v. regular insulin | 20 | 20 | 20 | 100 | ||||
total: | 40 | 40 | 40 | 100 | ||||
Umpierrez 2004b | I1: s.c. insulin aspart, every hour | Arbitrary estimation of a difference between groups of ≥ 4 hours to determine ketoacidosis as being clinically significant. A sample size of 15 participants was needed in each group to provide a power of 0.81, given an alpha error of 0.05 and a SD of 3 | ‐ | 15 | 15 | 15 | 100 | Mean hospital stay: 3.4 days |
I2: s.c. insulin aspart, every 2 h | 15 | 15 | 15 | 100 | Mean hospital stay: 3.9 days | |||
C: i.v. regular insulin | 15 | 15 | 15 | 100 | Mean hospital stay: 4.5 days | |||
total: | 45 | 45 | 45 | 100 | ||||
Della Manna 2005 | I: s.c. insulin lispro | ‐ | ‐ | 25 | 25 | 25 | 100 | Mean hospital stay: 2‐3 days |
C: i.v. regular insulin | 21 | 21 | 21 | 100 | ||||
total: | 46 | 46 | 46 | 100 | ||||
Ersöz 2006 | I: s.c. insulin lispro | ‐ | ‐ | 10 | 10 | 10 | 100 | ‐ |
C: i.v. regular insulin | 10 | 10 | 10 | 100 | ||||
total: | 20 | 20 | 20 | 100 | ||||
Karoli 2011 | I: s.c. insulin lispro | ‐ | ‐ | 25 | 25 | 25 | 100 | Mean hospital stay: 6 days |
C: i.v. regular insulin | 25 | 25 | 25 | 100 | Mean hospital stay: 6.6 days | |||
total: | 50 | 50 | 50 | 100 | ||||
Grand total | All interventions | 110 | 110 | |||||
All comparators | 91 | 91 | ||||||
All interventions and comparators | 201 | 201 |
aAccording to power calculation in study publication or report bDuration of intervention and/or follow‐up under randomised conditions until end of study
‐ denotes not reported
C: comparator; I: intervention; i.v.: intravenous; s.c.: subcutaneous; SD: standard deviation