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Table 2 Study procedures and data collection

From: Study protocol for a randomised controlled trial of insulin delivery by continuous subcutaneous infusion compared to multiple daily injections

Procedures Baseline Follow-up: scheduled 3-monthly clinic visit from time of diagnosis
Diagnosis Prior to start of treatment
  T0 T + 3 T + 6 T + 9 T + 12
Assessment of eligibility criteria X      
Signed consent form X      
Randomisation X      
Review of concomitant medications   X X X X X
Review of insulin use (insulin requirements)       
Patient diaries    X X X X
General practitioner prescriptions    X X X X
CSII pump download    X X X X
Review of medical history X    X   X
Blood glucose measurement Xb X X X X X
Blood pH measurement X      
Demographics X      
Study intervention   Xa     
Physical exam       
Height X   X X X X
Weight X X X X X X
Injection sites    X X X X
Symptom-directed    (X) (X) (X) (X)
Assessment of adverse events    (X) (X) (X) (X)
Clinical laboratory       
HbA1 c (local analysis)   X X X X X
HbA1 c (central analysis)   X X X X X
Chemistry (X)      X
Haematology (X)      X
Urinalysis (X)   X X X X
Patient completed measures       
Patient PedsQL   X   X   X
Parent PedsQL   X   X   X
Health utilities index 2   X X X X X
Resource use: RN completed CRF   X X X X X
  1. (X), as indicated/appropriate.
  2. aRandomised treatment will be commenced within 14 days of diagnosis; bmeasurement of blood glucose will be undertaken in the local hospital laboratory at diagnosis and by glucometer at remaining time points. RN: research nurse, CRF: case report form.