Table 4.
Adverse events.
| Control group A (n = 52) |
Intervention group B (n = 46) |
Intervention group C (n = 50) |
Not randomised (n = 27) | Total (N = 175) | |
|---|---|---|---|---|---|
| Participants with adverse or serious adverse events | 29 (55.8%) | 30 (65.2%) | 41 (82.0%) | 2 (7.4%) | 102 (58.3%) |
| Number of adverse or serious adverse events | 61 | 64 | 121 | 2 | 248 |
| Participants with serious adverse events | 8 (15.4%) | 7 (15.2%) | 7 (14.0%) | 0 | 22 (12.6%) |
| Number of serious adverse events | 9 | 9 | 8 | 0 | 26 |
| Participants with hypoglycaemia serious adverse eventsa | 1 (1.9%) | 0 | 0 | 0 | 1 (0.6%) |
| Number of hypoglycaemia serious adverse events | 1 | 0 | 0 | 0 | 1 |
| Participants with hypoglycaemia adverse eventsa (excluding serious) | 0 | 1 (2.2%) | 3 (6.0%) | 0 | 4 (2.3%) |
| Number of hypoglycaemia adverse events (excluding serious) | 0 | 1 | 3 | 0 | 4 |
| Participants with device-related adverse eventsb | 0 | 0 | 2 (4.0%) | 0 | 2 (1.1%) |
| Number of device-related adverse eventsb | 0 | 0 | 2 | 0 | 2 |
| Participants with study procedure-related adverse eventsb | 0 | 0 | 1 (2.0%) | 0 | 1 (0.6%) |
| Number of study procedure-related adverse eventsb | 0 | 0 | 1 | 0 | 1 |
Table includes the full analysis set. No serious adverse events were related to the study device or procedure.
a
No hypoglycaemic events were related to the device.
b
Device and/or study procedure adverse events were reported as ‘possibly related’ to sensor wear: one patient with superficial thrombophlebitis (mild) and one with redness (mild).