| Methods |
Trial Design: RCT
Randomisation procedure: not stated, randomised with 2 parallel groups
Allocation concealment: not reported
Blinding: not reported
Intention to treat analysis: stated intention to treat, but all participants originally randomised not included (9 excluded) |
| Participants |
Country: Italy
Setting: community
Number: 63
Age: low‐GI group 29 ± 11 years, high‐GI group 26 ± 8 years
Sex: low‐GI group 12 males,17 females, high‐GI group 9 males, 16 females
Inclusion criteria: type 1 diabetic patients
Exclusion criteria: renal failure, liver disease or symptomatic cardiovascular disease
Other characteristics: C‐peptide negative, BMI 23.9 ± 0.6 kg/m2, duration of diabetes 10.3 ± 6.3 years, treated with insulin, HbA1c levels between 7 and 10% |
| Interventions |
Trial intervention: low glycaemic index diet (GI= 70%, 50g/day fibre,
comparison intervention: high gycemic index diet (GI=90%, 15 g/day fibre)
Duration: 24 weeks |
| Outcomes |
Main outcome measure: % glycated haemoglobin, mean daily plasma glucose, lipids, hypoglycaemic events, body weight, insulin dose |
| Notes |
Source of funding: Italian National Research Council and Bayer Italy
Drop‐outs: 9 drop outs, reasons not given |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
