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. 2012 Sep 22;12:24. doi: 10.1186/1471-2253-12-24

Table 2.

Study timetable

  Visit 1 Visit 2 Visit 3 - 9 Visit 10 Visit 11 -12 Visit 13 Visit 14 Visit 15
 
 up to one month and a reference period1 of 2 h before Visit 2
 0 h2
 1–7 h (every hour) ± 5 min
 8 h ± 5 min
 9 and 10 h ± 5 min
 16 h ± 30 min
 24 h ± 30 min
 72 h ± 1 h
Informed consent
 ●
  
  
  
  
  
  
  
Eligibility criteria
 ●
 ●
  
  
  
  
  
  
Medical history
 ●
  
  
  
  
  
  
  
Concomitant medication
 ●
 ●
 ●
 ●
 ●
 ●
 ●
 ●
Physical examination
 ●
  
  
  
  
  
 ●
  
Vital signs3
 ●
 ●
 ●
 ●
 ●
 ●
 ●
 ●
Pregnancy test4
 ●
  
  
  
  
  
  
  
Placement of the CGM
  
 ●
  
  
  
  
  
  
CGM calibration
  
 ●
  
  
  
  
  
  
Continuous glucose and lactate monitoring
  
 ●
 ●
 ●
 ●
 ●
 ●
 up to every 2 h
Recalibration
  
  
  
 ●
  
  
  
  
Central venous blood sampling for the BGA5
  
  
 ●
 ●
 ●
 ●
 ●
  
Central venous blood sampling for central laboratory measurement6
  
 ●
  
 ●
  
 ●
 ●
  
Removal of CGM
  
  
  
  
  
  
  
 ●
Assessment of unwanted events/effects   ● ● ● ● ● ● ●

1 Priming, tempering and transient oscillation of the sensor systems.

2 Within 2 h of transfer to the recovery room or intensive care unit.

3 Heart rate, blood pressure, and tympanic body temperature.

4 Only females with reproductive potential.

5 Samples used to assess blood glucose, blood lactate, haematocrit, and haemoglobin.

6 Samples used to assess blood glucose and blood lactate levels.

CGM: continuous glucose monitor; BGA: blood gas analyser.