Table 3.
Adverse events and safety analyses
| Overall (n = 27) | Closed-loop (n = 26) | Control (n = 26) | |
|---|---|---|---|
| Number of severe hypoglycemia events | 1 | 1 | 0 |
| Number (%) of participants with severe hypoglycemic events | 1 (4) | 1 (4) | 0 (0) |
| Number of serious adverse events (not study-related) | 7 | 3 | 2 |
| Number (%) of participants with serious adverse events | 6 (22) | 3 (12) | 2 (8) |
| Number of other adverse events | 9 | 5 | 2 |
| Number (%) of participants with adverse events | 7 (26) | 4 (15) | 2 (8) |
| Number of device deficiencies | 6 | 5 | 1 |
| Number (%) of participants with device deficiencies | 6 (22) | 5 (19) | 1 (4) |
Severe hypoglycemia is defined as capillary glucose < 2.2 mmol l−1 or requiring assistance of another person.