Table 2 Data Collection
Month | Forms/samples |
|---|---|
0 | Diagnosis, consent and randomisation |
| Â | Baseline case report form (CRF) |
| Â | Blood sample - HbA1c analysis at central laboratory |
1 | Parent Questionnaire |
| Â | Child Questionnaire |
3 | Blood sample - for HbA1c analysis at central laboratory |
| Â | Follow up CRF |
12 | Blood sample - for HbA1c analysis at central laboratory |
| Â | Follow up CRF |
| Â | Parent Questionnaire |
| Â | Child Questionnaire |
24 | Blood sample - for HbA1c analysis at central laboratory |
| Â | Follow up CRF |
| Â | Parent Questionnaire |
| Â | Child Questionnaire |
Throughout 24 month follow up | CRF completion and data collection at routine follow up visits approximately every 3-4 months. |
up to 60 months | HbA1c measurements |
| Â | (taken and analysed at local Hospital) |