| Heller 2009 |
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, bolus or basal insulin). |
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). Last‐observation‐carried‐forward (LOCF) method was generally used for missing values on the endpoints that were measured after initiation of treatment and on more than one occasion. |
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. |
