| Methods |
Trial Design: RCT
Randomisation procedure: randomly assigned crossover design. Allocation concealment: not reported
Blinding of
outcome assessors: not reported
Intention to treat analysis: yes |
| Participants |
Country: Canada
Setting: community
Number: 7
Age: 12 ± 2 years
Sex: 6 male, 1 female
Inclusion criteria: Children with diabetes
Other characteristics: 102 ± 3% normal body weight, average insulin dose = 41.7 Units per day |
| Interventions |
Trial intervention: low glycaemic index starchy diet
comparison intervention: high glycaemic index diet
Duration: 6 weeks per intervention with a 4 week washout period |
| Outcomes |
Main outcome measures: lipids, glucose, %HbA1c, glycosylated albumin
Other outcomes: C‐peptide, insulin dose, growth |
| Notes |
Source of funding: Natural Sciences and Engineering Research Council of Canada and the Hospital for Sick Children Foundation
Drop‐outs: no |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
