Trial | Characteristic | Endpoint reported in publication | Endpoint not reported in publication | Time of measurementa |
Ferguson 2001 | Review's primary outcomes | |||
All‐cause mortality | ‐ | x | ‐ | |
Macrovascular complications | ‐ | x | ‐ | |
Microvascular complications | ‐ | x | ‐ | |
Severe hypoglycaemic episodes (P) | x | ‐ | 4, 8, 12, 16, 20, 24 weeks | |
Review's secondary outcomes | ||||
Glycaemic control (HbA1c) (O) | x | ‐ | 0, 24 weeks | |
Adverse events (O) | x | ‐ | 24 weeks | |
Health related quality of life (O) | xc | ‐ | 0, 24 weeks | |
Costs | ‐ | x | ‐ | |
Other than review's primary/secondary outcomes reported in publication (classification: P/S/O)b | ||||
Participant satisfaction (O), pre‐ and post‐prandial blood glucose (O) | ||||
Subgroups reported in publication | ||||
‐ | ||||
Home 2000 | Review's primary outcomes | |||
All‐cause mortality (O) | x | ‐ | 6 months | |
Macrovascular complications | ‐ | x | ‐ | |
Microvascular complications | ‐ | x | ‐ | |
Severe hypoglycaemic episodes (O) | x | ‐ | 6 months | |
Review's secondary outcomes | ||||
Glycaemic control (HbA1c) (P) | x | ‐ | 0, 2 weeks, 1, 2, 3, 4, 5, 6 months | |
Adverse events (O) | x | ‐ | 6 months | |
Health‐related quality of life (O) | xd | ‐ | 0, 3, 6 months | |
Costs | ‐ | x | ‐ | |
Other than review's primary/secondary outcomes reported in publication (classification: P/S/O)b | ||||
Treatment satisfaction (O) | ||||
Subgroups reported in publication | ||||
‐ | ||||
Iwamoto 2001 | Review's primary outcomes | |||
All‐cause mortality | ‐ | x | ‐ | |
Macrovascular complications | ‐ | x | ‐ | |
Microvascular complications | ‐ | x | ‐ | |
Severe hypoglycaemic episodes | ‐ | x | ‐ | |
Review's secondary outcomes | ||||
Glycaemic control (HbA1c) (P) | x | ‐ | 0, 4, 8, 16, 20, 24 weeks | |
Adverse events (O) | x | ‐ | 0, 4, 8, 16, 20, 24 weeks | |
Health‐related quality of life | ‐ | x | ‐ | |
Costs | ‐ | x | ‐ | |
Other than review's primary/secondary outcomes reported in publication (classification: P/S/O)b | ||||
Weight (O), insulin antibodies (O), insulin dose (O), blood pressure (O), fasting and post‐prandial blood glucose (O) | ||||
Subgroups reported in publication | ||||
‐ | ||||
Provenzano 2001 | Review's primary outcomes | |||
All‐cause mortality (O) | x | ‐ | ‐ | |
Macrovascular complications | ‐ | x | ‐ | |
Microvascular complications | ‐ | x | ‐ | |
Severe hypoglycaemic episodes | ‐ | x | ‐ | |
Review's secondary outcomes | ||||
Glycaemic control (HbA1c) (O) | x | ‐ | ‐2, 0, 6, 12, 18, 24 weeks | |
Adverse events (O) | x | ‐ | every 15 days | |
Health related quality of life | ‐ | x | ‐ | |
Costs | ‐ | x | ‐ | |
Other than review's primary/secondary outcomes reported in publication (classification: P/S/O)b | ||||
‐ | ||||
Subgroups reported in publication | ||||
‐ | ||||
Raskin 2000 | Review'sprimary outcomes | |||
All‐cause mortality | ‐ | x | ‐ | |
Macrovascular complications | ‐ | x | ‐ | |
Microvascular complications | ‐ | x | ‐ | |
Severe hypoglycaemic episodes (O) | x | ‐ | 12 months | |
Review'ssecondary outcomes | ||||
Glycaemic control (HbA1c) (P) | x | ‐ | 0, 12 months | |
Adverse events (O) | x | ‐ | 12 months | |
Health‐related quality of life | ‐ | x | ‐ | |
Costs | ‐ | x | ‐ | |
Other than review's primary/secondary outcomes reported in publication (classification: P/S/O)b | ||||
Post‐prandial blood glucose (O) | ||||
Subgroups reported in publication | ||||
‐ | ||||
Recasens 2003 | Review'sprimary outcomes | |||
All‐cause mortality | ‐ | x | ‐ | |
Macrovascular complications | ‐ | x | ‐ | |
Microvascular complications | ‐ | x | ‐ | |
Severe hypoglycaemic episodes (O) | x | ‐ | 12 months | |
Review'ssecondary outcomes | ||||
Glycaemic control (HbA1c) (O) | x | ‐ | 0, 12 months | |
Adverse events (O) | x | ‐ | 12 months | |
Health‐related quality of life | ‐ | x | ‐ | |
Costs | ‐ | x | ‐ | |
Other than review's primary/secondary outcomes reported in publication (classification: P/S/O)b | ||||
‐ | ||||
Subgroups reported in publication | ||||
‐ | ||||
Z011 2007 | Review'sprimary outcomes | |||
All‐cause mortality (O) | x | ‐ | 12 months | |
Macrovascular complications | ‐ | x | ‐ | |
Microvascular complications | ‐ | x | ‐ | |
Severe hypoglycaemic episodes (O) | x | ‐ | 12 months | |
Review'ssecondary outcomes | ||||
Glycaemic control (HbA1c) (O) | x | ‐ | 0, 3, 6, 12 months | |
Adverse events (O) | x | ‐ | 12 months | |
Health‐related quality of life | ‐ | x | ‐ | |
Costs | ‐ | x | ‐ | |
Other than review's primary/secondary outcomes reported in publication (classification: P/S/O)b | ||||
‐ | ||||
Subgroups reported in publication | ||||
‐ | ||||
Z013 2007 | Review'sprimary outcomes | |||
All‐cause mortality (O) | x | ‐ | 12 months | |
Macrovascular complications | ‐ | x | ‐ | |
Microvascular complications | ‐ | x | ‐ | |
Severe hypoglycaemic episodes (O) | x | ‐ | 12 months | |
Review'ssecondary outcomes | ||||
Glycaemic control (HbA1c) (O) | x | ‐ | 0, 3, 6, 12 months | |
Adverse events (O) | x | ‐ | 12 months | |
Health‐related quality of life | ‐ | x | ‐ | |
Costs | ‐ | x | ‐ | |
Other than review's primary/secondary outcomes reported in publication (classification: P/S/O)b | ||||
‐ | ||||
Subgroups reported in publication | ||||
‐ | ||||
Z015 2007 | Review'sprimary outcomes | |||
All‐cause mortality (O) | x | ‐ | 12 months | |
Macrovascular complications | ‐ | x | ‐ | |
Microvascular complications | ‐ | x | ‐ | |
Severe hypoglycaemic episodes (O) | x | ‐ | 12 months | |
Review'ssecondary outcomes | ||||
Glycaemic control (HbA1c) (O) | x | ‐ | 0, 3, 6, 12 months | |
Adverse events (O) | x | ‐ | 12 months | |
Health‐related quality of life | ‐ | x | ‐ | |
Costs | ‐ | x | ‐ | |
Other than review's primary/secondary outcomes reported in publication (classification: P/S/O)b | ||||
‐ | ||||
Subgroups reported in publication | ||||
‐ | ||||
aUnderlined data denote times of measurement for primary and secondary review outcomes, if measured and reported in the results section of the publication (other times represent planned but not reported points in time)
b(P) Primary or (S) secondary endpoint(s) refer to verbatim statements in the publication, (O) other endpoints relate to outcomes that were not specified as 'primary' or 'secondary' outcomes in the publication
cThe publication reports on only one questionnaire, while the trial documents described two different questionnaires
dOnly reported for the German subpopulation (Bott 2003) HbA1c: glycosylated haemoglobin A1c; O: other endpoint; P: primary endpoint; S: secondary endpoint |