Methods |
Trial Design: RCT
Randomisation procedure: not reported, crossover design
Allocation concealment: not reported
Blinding of outcome assessors: Unclear
Intention to treat analysis: yes |
Participants |
Country: France
Setting: Community
Number: 18
Age: 47 ± 12 years
Sex: 12 male, 6 female
Inclusion criteria: well‐controlled diabetes
Exclusion criteria: not stated
Other characteristics: type 1 diabetes n=12 (insulin controlled), type 2 diabetes n=6 (oral antidiabetic drugs), diabetes duration 12 ± 6 years, BMI 25 ± 3 kg /m2 |
Interventions |
Trial intervention: 5 weeks on low glycaemic index diet GI=38 ± 5 SD
comparison intervention: 5 weeks on high glycaemic index diet GI= 64 ± 2 SD |
Outcomes |
Main outcome measures: fructosamine
Other outcomes: self‐measured fasting blood glucose, postprandial blood glucose, daily blood glucose, body weight, HbA1c, insulin requirements, serum lipid levels |
Notes |
Source of funding: BSN, General Biscuit France, Pierre and Marie Curie University, Paris
Drop‐outs: no |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
B ‐ Unclear |