Table 3:
Adverse events and safety analyses in the intention-to-treat analysis population
| Prerandomisation (n=38) | Closed-loop group (n=36) | Sensor-augmented pump therapy group (n=37) | Washout (n=36) | |
|---|---|---|---|---|
|
| ||||
| Severe hypoglycaemia* events | 0 | 0 | 2 | 0 |
| Participants with severe hypoglycaemia | 0 | 0 | 2 (5%) | 0 |
| Incidence rate of severe hypoglycaemia/100 person years | .. | 0 | 17·6 | .. |
| Serious adverse events (not study related) | 1 | 0 | 1 | 0 |
| Participants with serious adverse events | 1 (3%) | 0 | 1 (3%) | 0 |
| Adverse events | 2 | 6 | 9 | 1 |
| Study related | 0 | 3 | 1 | 0 |
| Other | 2 | 3 | 8 | 1 |
| Participants with adverse events | 2 (5%) | 4 (11%) | 7 (19%) | 1 (3%) |
| Number of device deficiencies | ||||
| Pump related | 2 | 3 | 0 | 0 |
| Sensor related | 0 | 1 | 0 | 0 |
| App related | 0 | 1 | 0 | 0 |
| Phone related | 0 | 0 | 1 | 0 |
| Participants with device deficiencies | 2 (5%) | 5 (14%) | 1 (3%) | 0 |
*
Defined as requiring assistance of another person.