Table 5.

Adverse events in pregnancy trial participants

	CGM (n=107)	Control (n=107)	Odds ratio (OR) or rate ratio (RR; 95% CI)	p value
Participants with adverse events	51 (48%)	43 (40%)	OR 1·2 (0·8–1·8)	0·35
Number of events	109	78	RR 1·4 (1·0–1·8)	0·041
Participants with serious adverse events	8 (7%)	5 (5%)	OR 1·6 (0·5–4·9)	0·41
Number of serious adverse events	8	7	RR 1·1 (0·4–3·1)	0·82

All randomised participants were included. The serious adverse events were gastrointestinal (nausea and vomiting; n=4), respiratory or related to ear, nose, and throat (n=2), obstetric (n=2), diabetic ketoacidosis (n=1), headache or migraine (n=1), cortisol deficiency (n=1), skin rash (n=1), urinary or genital (n=1), foot drop (neurological; n=1), and breast cancer (n=1). CGM=continuous glucose monitoring.