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. 2019 Dec 12;19(8):1–108.

Table A1:

Risk of Biasa Among Randomized Controlled Trials (Cochrane Risk of Bias Tool)

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
a

Possible risk-of-bias levels: low, high, and unclear.