Table 3.

Adverse events

Adverse events	Open-access Phase Participants (N = 139)
Participants with adverse or serious adverse events	60 (43.2%)
Number of adverse events (excluding serious events)	126
Participants with serious adverse events	7 (5.0%)
Number of serious adverse events	9a
Participants with hypoglycemic serious adverse events	0 (0%)
Number of hypoglycemic serious adverse events	0
Participants with hypoglycemic adverse events	2 (1.4%)
Number of hypoglycemic adverse events	9
Participants with device-related adverse events	9 (6.5%)
Number of device-related adverse events	16
Participants discontinuing due to adverse events	5 (3.6%)b
Number of adverse events leading to discontinuation	5

Values in table are presented as a number with/without the percentage in parenthesis

^aThis number includes seven serious adverse events reported in the 6-month treatment phase results [9]

^bIn addition, 2 subjects withdrew during the open-access phase due to adverse events experienced during the 6-month treatment phase