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. 2021 Mar 4;2021(3):CD013498. doi: 10.1002/14651858.CD013498.pub2

Risk of bias for analysis 5.13 Non‐serious adverse events.

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 5.13.1 Adults
BEGIN Basal‐Bolus Type 1 Low risk of bias Participants were allocated to treatment with insulin degludec or insulin glargine in a 3:1 ratio. The Interactive Voice/Web Response System IV/WRS allocated the trial product to the participant at each dispensing and randomisation visit. There were no relevant baseline imbalances. Low risk of bias Open‐label trial design. The statistical evaluation of the full analysis set (FAS) was to follow the intention‐to‐treat (ITT) principle and participants were to contribute to the evaluation “as randomised”. 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. The statistical evaluation of the FAS was to follow the intention‐to‐treat (ITT) principle and participants were to contribute to the evaluation “as randomised”. The safety analysis set included all participants who received at least one dose of the investigational product or its comparator. Only endpoints derived after 52 weeks of treatment were to be analysed statistically. Missing values were imputed by last‐observation‐carried‐forward (LOCF) for all endpoints. Some concerns Open‐label design. Outcome measure could have been influenced by knowledge of the intervention received. It it unlikely that there were strong beliefs in beneficial or harmful effects of the interventions. Low risk of bias Data from full clinical study report. Only one measurement and result provided for the time point selected by review authors. Some concerns Open‐label design. Outcome measure could have been influenced by knowledge of the intervention received. It it unlikely that there were strong beliefs in beneficial or harmful effects of the interventions.
BEGIN Flex T1 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. The statistical evaluation of the full analysis set (FAS) was to follow the intention‐to‐treat (ITT) principle and participants were to contribute to the evaluation “as randomised”. 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. The statistical evaluation of the full analysis set (FAS) was to follow the intention‐to‐treat (ITT) principle and participants were to contribute to the evaluation “as randomised”. The safety analysis set included all participants who received at least one dose of the investigational product or its comparator. Only endpoints derived after 26 weeks of treatment were to be analysed statistically. Missing values were imputed by last‐observation‐carried‐forward (LOCF) for all endpoints. Some concerns Open‐label design. Outcome measure could have been influenced by knowledge of the intervention received. It it unlikely that there were strong beliefs in beneficial or harmful effects of the interventions. Low risk of bias Data from full clinical study report. Only one measurement and result provided for the time point selected by review authors. Some concerns Open‐label design. Outcome measure could have been influenced by knowledge of the intervention received. It it unlikely that there were strong beliefs in beneficial or harmful effects of the interventions.
Subgroup 5.13.2 Children
Urakami 2017 Some concerns No details on the randomisation process. There were no relevant baseline imbalances. Some concerns Open‐label trial design. Scarce information. Low risk of bias All randomised participants completed the study. Some concerns Open‐label design. Outcome measure could have been influenced by knowledge of the intervention received. It it unlikely that there were strong beliefs in beneficial or harmful effects of the interventions. Some concerns Scarce data from publication and study author. Probably only one measurement and result provided for the time point selected by review authors. Some concerns No details on the randomisation process. Open‐label design. Outcome measure could have been influenced by knowledge of the intervention received. It it unlikely that there were strong beliefs in beneficial or harmful effects of the interventions. Scarce information.