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. 2016 Jan 21;2016(1):CD011281. doi: 10.1002/14651858.CD011281.pub2

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