Is inhaled insulin (e.g. Afrezza) safe and effective for managing diabetes during pregnancy?

Inhaled Insulin During Pregnancy: Safety and Efficacy Considerations

Inhaled insulin (such as Afrezza) is not recommended for use during pregnancy due to insufficient safety data and the availability of established alternatives with proven safety profiles.

Current Recommendations for Insulin Use in Pregnancy

The management of diabetes during pregnancy requires careful consideration of medication safety and efficacy. According to the most recent guidelines:

• Insulin is the preferred and first-line pharmacological treatment for both type 1 and type 2 diabetes during pregnancy 1
• Either multiple daily injections or insulin pump technology can be used effectively in pregnancy complicated by type 1 diabetes 1
• None of the currently available human insulin preparations have been demonstrated to cross the placenta, making them safe for use during pregnancy 1

Specific Insulin Types in Pregnancy

Injectable Insulin Options

Injectable insulins have the most robust safety data for use during pregnancy:

• Short-acting insulin analogs: Insulin lispro and insulin aspart have demonstrated safety in pregnancy and may improve post-prandial glycemic control in women with type 1 diabetes 2
• Long-acting insulin analogs: Insulin detemir has more evidence supporting its use as first-line long-acting analog in pregnancy 2
• Insulin delivery methods: Both multiple daily injections and continuous subcutaneous insulin infusion (insulin pumps) are reasonable delivery strategies, with neither shown to be superior during pregnancy 1

Inhaled Insulin (Afrezza) in Pregnancy

The current clinical guidelines and research evidence do not support the use of inhaled insulin during pregnancy:

• There is a notable absence of safety and efficacy data specifically addressing inhaled insulin use during pregnancy in any of the major diabetes management guidelines 1
• The American Diabetes Association's Standards of Medical Care in Diabetes (2023,2024) does not mention inhaled insulin as an option for diabetes management during pregnancy 1
• None of the current automated insulin delivery systems, including inhaled insulin, have algorithms set to achieve pregnancy-specific glucose targets 1

Risks and Considerations

Several factors make inhaled insulin potentially problematic during pregnancy:

1. Unknown placental transfer: While injectable insulins do not cross the placenta, there is insufficient data regarding whether inhaled insulin or its carrier compounds might cross the placenta
2. Pulmonary changes in pregnancy: Pregnancy causes significant physiological changes in the respiratory system, which could affect inhaled insulin absorption and dosing
3. Lack of long-term safety data: No studies have evaluated the long-term outcomes of offspring exposed to inhaled insulin in utero
4. Dosing precision: Pregnancy requires frequent and precise insulin titration, which may be more challenging with inhaled formulations

Alternative Approaches

For patients who may have difficulty with injectable insulin:

• Patient education and support: Comprehensive education about insulin administration techniques and hypoglycemia management is essential 1
• Technology assistance: Consider insulin pump therapy or continuous glucose monitoring to improve adherence and outcomes
• Multidisciplinary care: Referral to specialized centers offering team-based care is recommended due to the complexity of insulin management in pregnancy 1

Common Pitfalls to Avoid

• Switching to oral agents: While some guidelines acknowledge that oral agents may be an alternative for patients unable to use insulin safely due to cost, language barriers, or other factors, these should only be considered after discussing known risks 1
• Inadequate monitoring: Pregnancy necessitates frequent titration of insulin to match changing requirements, underscoring the importance of daily and frequent blood glucose monitoring 1
• Delayed treatment intensification: The physiology of pregnancy causes progressive insulin resistance, requiring proactive dose adjustments throughout gestation

In conclusion, while inhaled insulin represents an innovation in diabetes management, its use during pregnancy cannot be recommended based on current evidence. Injectable insulin remains the gold standard for managing diabetes during pregnancy due to its established safety profile and the absence of placental transfer.