Items | (1) Resolution of symptoms | (2) Time to resolution of symptoms | (3) Blood or plasma glucose concentration at 20 minutes | (4) Resolution of hypoglycaemia | (5) Time to resolution of hypoglycaemia | (6) Adverse events | (7)Treatment delay | |
Trial limitations (risk of bias)a | Was random sequence generation used (i.e. no potential for selection bias)? | Unclear | NA | Unclear | NA | NA | NA | NA |
Was allocation concealment used (i.e. no potential for selection bias)? | Unclear | Unclear | ||||||
Was there blinding of participants and personnel (i.e. no potential for performance bias) or outcome not likely to be influenced by lack of blinding? | No (↓) | Yes | ||||||
Was there blinding of outcome assessment (i.e. no potential for detection bias) or was outcome measurement not likely to be influenced by lack of blinding? | No (↓) | Yes | ||||||
Was an objective outcome used? | No (↓) | Yes | ||||||
Were more than 80% of participants enrolled in trials included in the analysis (i.e. no potential reporting bias)?e | Yes | Yes | ||||||
Were data reported consistently for the outcome of interest (i.e. no potential selective reporting)? | Yes | Yes | ||||||
No other biases reported (i.e. no potential of other bias)? | Yes | Yes | ||||||
Did the trials end up as scheduled (i.e. not stopped early)? | Yes | Yes | ||||||
Indirectness | Were the populations in included studies applicable to the decision context? | Applicable | Applicable | |||||
Were the interventions in the included studies applicable to the decision context? | Highly applicable | Highly applicable | ||||||
Was the included outcome not a surrogate outcome? | Yes | Yes | ||||||
Was the outcome timeframe sufficient? | Sufficient | Sufficient | ||||||
Were the conclusions based on direct comparisons? | Yes | Yes | ||||||
Imprecisionc | What is the magnitude of the median sample size (high: 300 participants, intermediate: 100‐300 participants, low: < 100 participants)?e | Low (↓) | Low (↓) | |||||
What was the magnitude of the number of included studies (large: > 10 studies, moderate: 5‐10 studies, small: < 5 studies)?e | Small (↓) | Small (↓) | ||||||
Was the outcome a common event (e.g. occurs more than 1/100)? | Yes | Not applicable | ||||||
Publication biasd | Was a comprehensive search conducted? | Yes | Yes | |||||
Was grey literature searched? | Yes | Yes | ||||||
Were no restrictions applied to study selection on the basis of language? | Yes | Yes | ||||||
There was no industry influence on studies included in the review? | Yes | Yes | ||||||
aQuestions on risk of bias are answered in relation to the majority of the aggregated evidence in the meta‐analysis rather than to individual trials.
bQuestions on inconsistency are primarily based on visual assessment of forest plots and the statistical quantification of heterogeneity based on I². cWhen judging the width of the confidence interval it is recommended to use a clinical decision threshold to assess whether the imprecision is clinically meaningful. dQuestions address comprehensiveness of the search strategy, industry influence, funnel plot asymmetry and discrepancies between published and unpublished trials. eDepends on the context of the systematic review area. (↓): key item for potential downgrading the certainty of the evidence (GRADE) as shown in the footnotes of the 'Summary of finding' table(s); NA: not applicable |