Table A1:
Author, Year | Random Sequence Generation | Allocation Concealment | Blinding of Participants and Personnel | Incomplete Outcome Data | Selective Reporting | Other Bias |
---|---|---|---|---|---|---|
Bolinder et al, 201632 | Low risk; participants were randomized using a computer random number generator | Low risk; there is no indication that intervention allocations could have been foreseen before or during enrolment | Low risk; although participants were not blinded on intervention, it is unlikely that lack of blinding affected treatment adherence or resulted in differential care | High risk; missing data were imputed by the last observation carried forward for the primary endpoint. This could have induced outcome misclassification and underestimation of random errors | Unknown risk | Low risk for the influence of flash inaccuracy on hypoglycemic outcomes based on the findings from quantitative bias analysis |
Haak et al, 201633 | Low risk; participants were randomized using a computer random number generator | Low risk; there is no indication that intervention allocations could have been foreseen before or during enrolment | Low risk; although participants were not blinded on intervention, it is unlikely that lack of blinding affected treatment adherence or resulted in differential care | High risk; missing data were imputed by the last observation carried forward for the primary endpoint. This could have induced outcome misclassification and underestimation of random errors | Unknown risk | Low risk for the influence of flash inaccuracy on hypoglycemic outcomes based on the findings from quantitative bias analysis |
Possible risk-of-bias levels: low, high, and unclear.