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, 2, 3
Why Tresiba Is Not Recommended
Insulin is the preferred and only recommended first-line pharmacologic agent for managing diabetes in pregnancy, but this recommendation specifically applies to insulin formulations with established safety profiles in pregnancy. 1, 2, 3
Critical Safety Concerns with Tresiba
Clinical experience with insulin degludec in pregnant women is very limited, making it impossible to assess safety for mother and fetus. 4
There are no adequate data on insulin degludec use during pregnancy, and it should be avoided until further safety data become available. 4
Potential cardiovascular risks have been raised by FDA meta-analyses showing approximately 60% increase in cardiovascular complications (myocardial infarction, stroke, cardiovascular death) compared to other insulins, though this remains under investigation. 4, 5
Recommended Insulin Options During Pregnancy
Use insulin formulations with established pregnancy safety profiles:
NPH (insulin isophane) remains the first-choice long-acting insulin for pregnant women with diabetes. 4
Rapid-acting insulin analogues (insulin aspart, lispro) are appropriate for mealtime coverage. 1, 3
Both multiple daily injections and continuous subcutaneous insulin infusion are acceptable delivery strategies during pregnancy. 1, 3
Glycemic Targets During Pregnancy
When using appropriate insulin formulations, target the following glucose levels:
- Fasting glucose <95 mg/dL 2, 3
- 1-hour postprandial <140 mg/dL OR 2-hour postprandial <120 mg/dL 1, 2, 3
- A1C target <6% if achievable without significant hypoglycemia, but may relax to <7% if necessary to prevent hypoglycemia. 2, 3
Important Pregnancy-Specific Insulin Considerations
Insulin requirements change dramatically throughout pregnancy: enhanced sensitivity in early pregnancy, increasing resistance in second trimester, and doubling of requirements in third trimester. 3
Insulin resistance drops rapidly with placental delivery, requiring immediate postpartum dose reduction to prevent severe hypoglycemia. 1, 3
Hypoglycemia risk increases in first trimester with altered counterregulatory response, necessitating education for patients and family members. 1
Diabetic ketoacidosis occurs at lower glucose thresholds during pregnancy (<200-250 mg/dL vs typical >250 mg/dL), requiring ketone monitoring and patient education. 1, 2
Common Pitfall to Avoid
Do not assume all insulins are equivalent in pregnancy. While the general class of "insulin" is preferred, only specific formulations with established safety data should be used. Tresiba's limited pregnancy experience and potential cardiovascular concerns make it inappropriate despite being an insulin analogue. 4