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Table 2 Study timetable

From: Design of a prospective clinical study on the agreement between the Continuous GlucoseMonitor, a novel device for CONTinuous ASSessment of blood GLUcose levels, and the RAPIDLab® 1265 blood gas analyser: The CONTASSGLU study

 

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. 1 Priming, tempering and transient oscillation of the sensor systems.
  2. 2 Within 2 h of transfer to the recovery room or intensive care unit.
  3. 3 Heart rate, blood pressure, and tympanic body temperature.
  4. 4 Only females with reproductive potential.
  5. 5 Samples used to assess blood glucose, blood lactate, haematocrit, and haemoglobin.
  6. 6 Samples used to assess blood glucose and blood lactate levels.
  7. CGM: continuous glucose monitor; BGA: blood gas analyser.