Sensitivity analyses
| OR (95% CI) | p Value | |
|---|---|---|
| (A) Association between mortality and hypoglycaemia, whether or not requiring medical help | ||
| No hypoglycaemia during follow-up | (Reference) | |
| Only mild hypoglycaemia during follow-up | 0.37 (0.23 to 0.59) | <0.01 |
| Severe hypoglycaemia during follow-up, but no medical help reported | 0.57 (0.23 to 1.46) | 0.24 |
| Severe hypoglycaemia during follow-up, requiring medical help | 1.38 (0.31 to 6.11) | 0.68 |
| (B) Association between mild and severe hypoglycaemia, whether or not combined with mild hypoglycaemia, and mortality | ||
| No hypoglycaemia during follow-up | (Reference) | |
| Only mild hypoglycaemia during follow-up | 0.37 (0.23 to 0.59) | <0.01 |
| Mild and severe hypoglycaemia during follow-up | 0.39 (0.09 to 1.62) | 0.19 |
| Only severe hypoglycaemia during follow-up | 1.00 (0.39 to 2.58) | 1.00 |
| (C) Dose–response association between mild hypoglycaemia and mortality | ||
| Number of events reported during follow-up* | ||
| No hypoglycaemia during follow-up | (Reference) | |
| ≤2 mild hypoglycaemic events per year | 0.52 (0.23 to 1.16) | 0.11 |
| 3–10 mild hypoglycaemic events per year | 0.52 (0.22 to 1.22) | 0.13 |
| 12–32 mild hypoglycaemic events per year | 0.38 (0.16 to 0.88) | 0.03 |
| ≥33 mild hypoglycaemic events per year | 0.14 (0.04 to 0.59) | <0.01 |
| Number of events reported at baseline† | ||
| No hypoglycaemia | (Reference) | |
| ≤2 mild hypoglycaemic events | 0.72 (0.30 to 1.68) | 0.44 |
| 3–11 mild hypoglycaemic events | 0.66 (0.26 to 1.67) | 0.38 |
| 12–48 mild hypoglycaemic events | 0.29 (0.11 to 0.81) | 0.02 |
| ≥52 mild hypoglycaemic events | 0.30 (0.09 to 0.97) | 0.04 |
Table 3C: For both models, only patients who did not report severe hypoglycaemia were taken into account.
*For this analysis, the average number of mild hypoglycaemic events per year was calculated by dividing the total number of reported mild events during follow-up by the number of measurements. This number was categorised based on quartiles.
†For this analysis, the number of hypoglycaemic events reported at baseline was categorised based on quartiles.