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 | Â | Â | Â | Â | Â |
Signed consent form | X | Â | Â | Â | Â | Â |
Randomisation | X | Â | Â | Â | Â | Â |
Review of concomitant medications | Â | X | X | X | X | X |
Review of insulin use (insulin requirements) | Â | Â | Â | Â | Â | Â |
Patient diaries | Â | Â | X | X | X | X |
General practitioner prescriptions | Â | Â | X | X | X | X |
CSII pump download | Â | Â | X | X | X | X |
Review of medical history | X | Â | Â | X | Â | X |
Blood glucose measurement | Xb | X | X | X | X | X |
Blood pH measurement | X | Â | Â | Â | Â | Â |
Demographics | X | Â | Â | Â | Â | Â |
Study intervention | Â | Xa | Â | Â | Â | Â |
Physical exam | Â | Â | Â | Â | Â | Â |
Height | X | Â | X | X | X | X |
Weight | X | X | X | X | X | X |
Injection sites | Â | Â | X | X | X | X |
Symptom-directed | Â | Â | (X) | (X) | (X) | (X) |
Assessment of adverse events | Â | Â | (X) | (X) | (X) | (X) |
Clinical laboratory | Â | Â | Â | Â | Â | Â |
HbA1 c (local analysis) | Â | X | X | X | X | X |
HbA1 c (central analysis) | Â | X | X | X | X | X |
Chemistry | (X) | Â | Â | Â | Â | X |
Haematology | (X) | Â | Â | Â | Â | X |
Urinalysis | (X) | Â | X | X | X | X |
Patient completed measures | Â | Â | Â | Â | Â | Â |
Patient PedsQL | Â | X | Â | X | Â | X |
Parent PedsQL | Â | X | Â | X | Â | X |
Health utilities index 2 | Â | X | X | X | X | X |
Resource use: RN completed CRF | Â | X | X | X | X | X |