| Outcome Measures: |
Primary: Beta-cell function at 48 weeks, Change in average C-peptide concentration during a 2-hour mixed meal challenge, 0 weeks - 48 weeks | Secondary: Beta-cell function at 24, 72 and 96 weeks, Change in average C-peptide concentration during a 2-hour mixed meal challenge, 0, 24, 72 and 96 weeks|Glucose regulation, Proportion of time in the range 3.9-10mmol/l, time below 3.9mmol/l and glucose %CV measured by continuous glucose monitoring (CGM), 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72 and 96 weeks|Estimated C-peptide concentration, Average C-peptide concentration estimated from fasting glucose, C-peptide, HbA1c, body mass index, disease duration and insulin dose, -2, 24, 48, 72 and 96 weeks|Frequency of hypoglycemic events, Frequency of glucose readings \<3.0mmol/l, determined by CGM and correcting for CGM wear time, 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72 and 96 weeks|Hemoglobin A1c levels, Change in HbA1c levels, 0, 12, 24, 36, 48, 60, 72 and 96 weeks|Insulin use, Daily insulin dose at all visits, Every 4 weeks for 96 weeks|Weight, body mass index and sitting blood pressure, Change in weight, body mass index and blood pressure, 0, 12, 24, 48, 60, 72 and 96 weeks|Diabetes antibody levels, Insulin, GAD, IA2 and ZnT8 autoantibody concentrations, -2, 0, 4, 12, 24, 48, 60, 72 and 96 weeks|Quality of life assessment, Assessed by questionnaire, -2, 0, 24, 48, 72 and 96 weeks|Adverse events, Frequency and severity of adverse events, All visits for 96 weeks
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| Locations: |
The Children's Hospital at Westmead, Westmead, New South Wales, 2145, Australia|Queensland Children's Hospital, South Brisbane, Queensland, 4101, Australia|Women's and Children's Hospital, North Adelaide, South Australia, 5006, Australia|The Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia|The Royal Children's Hospital, Parkville, Victoria, 3052, Australia|Perth Children's Hospital, Nedlands, Western Australia, 6009, Australia
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