Methods |
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Participants |
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Interventions | Treatment group
Control group
Baseline immunosuppression
Co‐interventions
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Outcomes | Primary outcomes
Secondary outcomes
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Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Study was described as randomised, method of randomisation was not reported |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding was not possible due to the nature of the treatment |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to permit judgement |
Incomplete outcome data (attrition bias) All outcomes | High risk | A large number of patients did not complete the study, however, all the withdrawals and losses to follow‐up were described. Although dropout rate was high, the authors wrote that there was no significant difference in dropout rates between groups, and no obvious source of bias that would affect conclusions, regarding maximised versus standard glycaemic control. However, with regard to the breakdown of causes of drop‐out, the intensive insulin therapy group had a higher rate of voluntary withdrawals 9/27 or 33.33% (i.e. people who could not tolerate the intensive insulin therapy) compared with the less intensive insulin therapy group 4/24 or 16.67%. This could lead to attrition bias, given that the authors did a per protocol analysis for outcomes show |
Selective reporting (reporting bias) | Low risk | The prespecified primary outcome of glomerular mesangial expansion as determined by electron microscopy was reported |
Other bias | High risk | There was an additional risk of selection bias because there was a change in the randomisation method ‐ initially investigators randomised 2:1 in favour of the intensive group as investigators hypothesised that this group would have more withdrawals from the study than the standard group. As this was not the case, in the seventh year of recruiting, they randomised 2:1 in favour of the standard group Funding source: Grants from the National Institute of Health and the National Centre for Research Resources. Also funding from Eli Lilly and Boehringer Mannheim Diagnostics, Minnesota Medical Foundation and the American Diabetes Association |