| Study |
Bias |
| Randomisation process |
Deviations from intended interventions |
Missing outcome data |
Measurement of the outcome |
Selection of the reported results |
Overall |
| Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
| Subgroup 1.22.1 Published |
| Bartley 2008 |
Low risk of bias |
Randomisation was carried out using a telephone randomisation system (Interactive Voice Response System (IVRS)). There were no relevant baseline imbalances. |
Low risk of bias |
Open‐label trial design. A modified intention‐to‐treat analysis was applied (all randomised participants exposed to at least one dose of trial product). |
Low risk of bias |
Withdrawals and reasons for withdrawal were documented, did not differ substantially between intervention groups and did not appear to be related to health status. Modified intention‐to‐treat analysis (ITT) was used as the primary analysis for both efficacy and safety. Missing observations were considered missing at random in all analyses. |
Low risk of bias |
Open‐label design with outcome measure unlikely influenced by lack of blinding. |
Low risk of bias |
Data from full clinical study report. Only one measurement and result provided for the time point selected by review authors. |
Low risk of bias |
No risk of bias identified. |
| Robertson 2007 |
Low risk of bias |
Randomisation was carried out using a telephone randomisation system (Interactive Voice Response System (IVRS)). There were no relevant baseline imbalances. |
Low risk of bias |
Open‐label trial design. A modified intention‐to‐treat analysis was applied (all randomised participants exposed to at least one dose of trial product). |
Low risk of bias |
Withdrawals and reasons for withdrawal were documented, did not differ substantially between intervention groups and did not appear to be related to health status. Modified intention‐to‐treat analysis set was used (all exposed participants were analysed). Missing observations were considered missing at random in all analyses. |
Low risk of bias |
Open‐label design with outcome measure unlikely influenced by lack of blinding. |
Low risk of bias |
Data from full clinical study report. Only one measurement and result provided for the time point selected by review authors. |
Low risk of bias |
No risk of bias identified. |
| Russell‐Jones 2004 |
Low risk of bias |
Randomisation was carried out using a telephone randomisation system, the Interactive Voice Response System (IVRS). Block randomisation within individual trial sites was handled by the system. There were no relevant baseline imbalances. |
Low risk of bias |
Open‐label trial design. A modified intention‐to‐treat analysis was applied (all participants exposed to at least one dose of trial product). |
Low risk of bias |
Withdrawals and reasons for withdrawal were documented, did not differ substantially between intervention groups and did not appear to be related to health status. Modified intention‐to‐treat analysis (ITT) set was used (all exposed participants were analysed). Missing observations were considered missing at random in all analyses. All primary and secondary efficacy analyses were based on the ITT analysis set. |
Low risk of bias |
Open‐label design with outcome measure unlikely influenced by lack of blinding. |
Low risk of bias |
Data from full clinical study report. Only one measurement and result provided for the time point selected by review authors. |
Low risk of bias |
No risk of bias identified. |
| Thalange 2013 |
Low risk of bias |
Randomisation was carried out using a telephone/web based randomisation system called Interactive Voice Response System (IVRS)/Interactive Web Response System (IWRS). Stratification was applied by age group (2‐5 and 6‐16 years old). There were no relevant baseline imbalances. |
Low risk of bias |
Open‐label trial design. A modified intention‐to‐treat analysis was applied (all participants exposed to at least one dose of trial product with a post‐baseline observation). |
Low risk of bias |
Withdrawals and reasons for withdrawal were documented, did not differ substantially between intervention groups and did not appear to be related to health status. Modified intention‐to‐treat analysis set was used (all exposed participants were analysed). Missing observations were considered missing at random in all analyses. |
Low risk of bias |
Open‐label design with outcome measure unlikely influenced by lack of blinding. |
Low risk of bias |
Data from full clinical study report. Only one measurement and result provided for the time point selected by review authors. |
Low risk of bias |
No risk of bias identified. |
| Vague 2003 |
Low risk of bias |
Randomisation was carried out using a telephone randomisation system (Interactive Voice Response System (IVRS)). There were no relevant baseline imbalances. |
Low risk of bias |
Open‐label trial design. A modified intention‐to‐treat analysis was applied (all randomised participants exposed to at least one dose of trial product). |
Low risk of bias |
Withdrawals and reasons for withdrawal were documented, did not differ substantially between intervention groups and did not appear to be related to health status. Modified intention‐to‐treat analysis set was used (all exposed participants were analysed). Missing observations were considered missing at random in all analyses. |
Low risk of bias |
Open‐label design with outcome measure unlikely influenced by lack of blinding. |
Low risk of bias |
Data from full clinical study report. Only one measurement and result provided for the time point selected by review authors. |
Low risk of bias |
No risk of bias identified. |
| Subgroup 1.22.2 Unpublished |
| NCT00605137 |
Low risk of bias |
Randomisation codes were prepared by a responsible person for randomisation and carried out by the registration centre. Randomisation was stratified by type of bolus insulin. Minor baseline differences did not indicate a problem with randomisation. |
Low risk of bias |
Open‐label trial design. For all efficacy endpoints the analyses were performed on a full analysis set (FAS), i.e. all randomised participants who had any available efficacy data after receiving the trial product. |
Low risk of bias |
Withdrawals and reasons for withdrawal were documented, did not differ substantially between intervention groups and did not appear to be related to health status. For all efficacy endpoints the analyses were performed on a full analysis set (FAS), i.e. all randomised participants who had any available efficacy data after receiving the trial product. |
Low risk of bias |
Open‐label design with outcome measure unlikely influenced by lack of blinding. |
Low risk of bias |
Data from study protocol, clinical study synopsis and some translated pages of the clinical study report. Only one measurement and result provided for the time point selected by review authors. |
Low risk of bias |
No risk of bias identified. |
| Standl 2004 |
Low risk of bias |
Randomisation was carried out using a telephone randomisation system (Interactive Voice Response System (IVRS)). There were no relevant baseline imbalances. |
Low risk of bias |
Open‐label trial design. A modified intention‐to‐treat analysis was applied (all randomised participants exposed to at least one dose of trial product). |
Low risk of bias |
Withdrawals and reasons for withdrawal were documented, did not differ substantially between intervention groups and did not appear to be related to health status. Modified intention‐to‐treat analysis set was used (all exposed participants were analysed). Missing observations were considered missing at random in all analyses. |
Low risk of bias |
Open‐label design with outcome measure unlikely influenced by lack of blinding. |
Low risk of bias |
Data from full clinical study report. Only one measurement and result provided for the time point selected by review authors. |
Low risk of bias |
No risk of bias identified. |
