Tresiba (Insulin Degludec) Safety in Pregnancy
Tresiba (insulin degludec) should NOT be used during pregnancy; instead, use standard insulin formulations such as NPH, regular insulin, or other well-studied insulin analogues like insulin aspart or lispro. 1
Why Tresiba Is Not Recommended
Clinical experience with insulin degludec in pregnant women is very limited, and it is best avoided during pregnancy. 2 The evidence base for Tresiba in pregnancy is insufficient to establish safety for both mother and fetus, which is critical given the vulnerable developmental period.
Preferred Insulin Options During Pregnancy
The American Diabetes Association clearly states that insulin is the preferred agent for management of both type 1 and type 2 diabetes in pregnancy. 1, 3 However, this recommendation refers to well-studied insulin formulations, not newer analogues like degludec.
Safe Insulin Choices Include:
- NPH (insulin isophane): The standard long-acting human insulin with extensive pregnancy safety data 2
- Rapid-acting analogues (insulin aspart, lispro): Well-studied in pregnancy 4
- Regular human insulin: Long-established safety profile 1
- Insulin glargine and detemir: Have more pregnancy data than degludec, though still less than NPH 2
Delivery Methods
Either multiple daily injections or continuous subcutaneous insulin infusion (pump therapy) can be used safely in pregnancy complicated by type 1 diabetes. 1, 4
Glycemic Targets During Pregnancy
When using appropriate insulin formulations, target the following glucose levels 3, 4:
- Fasting: <95 mg/dL (5.3 mmol/L)
- 1-hour postprandial: <140 mg/dL (7.8 mmol/L), OR
- 2-hour postprandial: <120 mg/dL (6.7 mmol/L)
- A1C: <6% if achievable without significant hypoglycemia 3, 4
Critical Safety Considerations
Hypoglycemia Risk
Women with type 1 diabetes have increased risk of hypoglycemia in the first trimester with altered counterregulatory response that may decrease hypoglycemia awareness. 1 Education for patients and family members about prevention, recognition, and treatment is essential. 4
Insulin Requirements Change Dramatically
- Enhanced insulin sensitivity occurs in early pregnancy 4
- Insulin resistance doubles by the third trimester 4
- Insulin requirements drop dramatically immediately after delivery of the placenta 1, 4
Diabetic Ketoacidosis (DKA)
Pregnancy is a ketogenic state, and women with type 1 diabetes are at risk for DKA at lower blood glucose levels than in the nonpregnant state. 1 DKA carries a high risk of stillbirth. 1
Common Pitfall to Avoid
Do not continue Tresiba simply because a patient was using it before pregnancy. The lack of pregnancy safety data necessitates switching to well-studied insulin formulations at or before conception. 2 The additional risk of the 200 units/mL concentration creating dosing errors further supports avoiding this formulation. 2