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. 2016 Jun 30;2016(6):CD012161. doi: 10.1002/14651858.CD012161
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