Table 2.
Summary of findings in 10 randomised controlled trials of hypoglycaemia according to GRADE framework
| Quality assessment | No (%) of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | All studies | Placebo | Relative risk (95% CI) | Absolute risk (95% CI) | ||||
| Not serious* | Not serious† | Not serious | Not serious‡ | Dose-response gradient | 479/4020 (11.9) | 169/2526 (6.7) | 1.52 (1.29 to 1.80) | 35 more per 1000 (from 19 more to 54 more) | High | Critical§ | ||
*Only three studies were judged to have a high risk of detection bias. Among them, a high risk of reporting bias was found in one study. Nevertheless, when these studies were excluded from analysis, the result did not change substantially.
†No heterogeneity was found among estimates.
‡Sample size is large (n=6526), number of events high (648), and confidence intervals of pooled risk ratio clearly do not cross the line of no effect (lower bound of 95% confidence interval 1.29)
§Hypoglycaemia is the most common adverse reaction related to glucose lowering treatment. It increases the risk of all cause mortality and cardiovascular events. Symptoms related to hypoglycaemia (eg, nervousness, sweating, trembling, weakness, palpitations) affect quality of life.