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
|