Pregnancies complicated by hypoglycemia and hyperglycemia pose an increased risk of birth defects, pregnancy loss, or other adverse events. Insulin requirements may decrease during the first trimester; generally increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring of glucose control is essential.

AU TGA pregnancy category: Not assigned; this class of drugs is generally exempt from pregnancy classification.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Use is considered acceptable

AU TGA pregnancy category: Not Assigned
US FDA pregnancy category: B

Comment: Good glycemic control is essential for patients with diabetes or a history of gestational diabetes before conception and throughout pregnancy.

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Use is considered acceptable

Excreted into human milk: Yes

Breast-feeding mothers may require adjustments in insulin dose.

Exogenous insulins, including the newer biosynthetic insulins (i.e. aspart, detemir, glargine, glulisine, lispro) appear to be excreted into breast milk. Insulin is a protein that is inactivated if taken by mouth. If absorbed, it would be destroyed in the digestive tract of the infant.

Lactation onset occurs later in women with type 1 diabetes, and there is an even greater delay in those with poor glucose control. However, once established lactation persists as long in mothers with diabetes as mothers without. Insulin requirements are generally lower in women who breastfeed, most likely due to glucose being used for milk production. In a small well controlled study in breastfeeding women with type 1 diabetes using continuous subcutaneous insulin infusion, basal and total daily insulin requirements were found to be 0.21 and 0.56 units/kg, respectively in breastfeeding women compared to 0.33 and 0.75 units/kg per day in similar women who did not breastfeed.

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