| Methods |
Trial Design: RCT
Randomisation procedure: not reported, parallel study
Allocation concealment: not reported
Blinding of
outcome assessors: yes
Intention to treat analysis: yes, but not at 12 months Power calculation: yes |
| Participants |
Country: Australia
Setting: community
Number: 104 children, low‐GI group n=55, CHOx group n=49
Age: children low‐GI group 10.7 ± 1.6 years, CHOx group 10.2 ± 1.6 years
Sex: low‐GI group 49% male, CHOx group 51% male
Inclusion criteria: children with type 1 diabetes |
| Interventions |
Trial intervention: low glycaemic index diet,
comparison intervention: measured carbohydrate exchange (CHOx)
Duration: 12 months |
| Outcomes |
Main outcome measures: % glycated haemoglobin, insulin dose, weight, height, dietary intake, incidence of hypo‐ and hyper‐glycemia, quality of life |
| Notes |
Source of funding: Diabetes Australia Research Trust
Drop‐outs: accounted for |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
