Table 4

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

NHuman insulin onlyInsulin analogues only
Short-acting analogues onlyShort-acting analogues and long-acting analogues
46321794
Major congenital anomaly
 n (%)37 (8.0)9 (4.2)5 (5.3)
 Crude OR (95% CI)Reference0.49 (0.23 to 1.04)0.64 (0.24 to 1.68)
 Adjusted OR (95% CI)*Reference0.57 (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)Reference0.10 (0.01 to 0.72)0.23 (0.03 to 1.70)
 Adjusted OR (95% CI)*Reference0.12 (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)Reference0.74 (0.40 to 1.36)0.68 (0.28 to 1.64)
 Adjusted OR (95% CI)*Reference0.94 (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.