Table 4.

ORs of non-chromosomal congenital anomalies by type of insulin analogues among fetuses exposed to insulin analogues only in the first trimester

N	Human insulin only	Insulin analogues only
		Short-acting analogues only	Short-acting analogues and long-acting analogues
	463	217	94
Major congenital anomaly
n (%)	37 (8.0)	9 (4.2)	5 (5.3)
Crude OR (95% CI)	Reference	0.49 (0.23 to 1.04)	0.64 (0.24 to 1.68)
Adjusted OR (95% CI)*	Reference	0.57 (0.26 to 1.21)	0.54 (0.20 to 1.43)
Congenital heart defects
n (%)	21 (4.5)	1 (0.5)	1 (1.1)
Crude OR (95% CI)	Reference	0.10 (0.01 to 0.72)	0.23 (0.03 to 1.70)
Adjusted OR (95% CI)*	Reference	0.12 (0.02 to 0.92)	0.18 (0.02 to 1.35)
Adverse outcomes†
n (%)	42 (9.1)	15 (6.9)	6 (6.4)
Crude OR (95% CI)	Reference	0.74 (0.40 to 1.36)	0.68 (0.28 to 1.64)
Adjusted OR (95% CI)*	Reference	0.94 (0.45 to 1.98)	0.53 (0.21 to 1.36)

*Adjusted for centre as a random effect and adjusted for HbA1c value in the first trimester.

†Including major congenital anomaly or fetal deaths.

HbA1c, haemoglobin A1c.