Recasens 2003.
| Methods | Parallel randomised controlled clinical trial | |
| Participants |
Inclusion criteria: people with newly diagnosed type 1 diabetes Exclusion criteria: ‐ Diagnostic criteria: National Diabetes Data Group 1979 |
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| Interventions |
Number of study centres: ‐ Treatment before study: ‐ Titration period: ‐ Insulin lispro vs. RHI (see Appendix 2) |
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| Outcomes |
Outcomes reported in abstract of publication: HbA1c, proportion of participants with HbA1c < 6%, daily blood glucose profiles, mild hypoglycaemic episodes, β‐cell function Primary outcome(s): not defined Secondary outcome(s): not defined Other outcome(s): HbA1c, hypoglycaemia (mild, severe) |
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| Study details |
Run‐in period: ‐ Study terminated before regular end: no |
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| Publication details |
Language of publication: English Funding: ‐ Publication status: full article in a peer‐reviewed journal |
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| Stated aim for study | Quote: "The aim of the study was to examine the effects of intensive insulin therapy using lispro on metabolic control, immunogenicity and β‐cell function of newly diagnosed type 1 diabetic subjects in comparison with intensive insulin therapy using regular insulin" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were randomly assigned to intensive insulin therapy using insulin lispro or intensive insulin therapy using regular insulin" Comment: not described |
| Allocation concealment (selection bias) | Unclear risk | Comment: not described |
| Blinding of participants and personnel (performance bias) Objective outcomes | High risk | Quote: "open‐label" Comment: not blinded |
| Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Quote: "open‐label" Comment: not blinded |
| Blinding of outcome assessment (detection bias) Objective outcomes | Unclear risk | Comment: not described |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Comment: not described |
| Incomplete outcome data (attrition bias) Objective outcomes | High risk | Comment: reasons for drop‐outs not described, handling of missing values in analysis unclear |
| Incomplete outcome data (attrition bias) Subjective outcomes | High risk | Comment: reasons for drop‐outs not described, handling of missing values in analysis unclear |
| Selective reporting (reporting bias) | Unclear risk | Comment: not enough information to make judgement |
| Other bias | Unclear risk | Comment: no primary endpoint defined |