When to add Jardiance (Empagliflozin) for Gestational Diabetes Mellitus (GDM) management?

Jardiance (Empagliflozin) is NOT Recommended for Gestational Diabetes Mellitus Management

Jardiance (empagliflozin) should not be used for gestational diabetes mellitus (GDM) management as it lacks safety data in pregnancy and is not approved for this indication.

Current Guidelines for GDM Pharmacological Management

First-Line Approach

1. Lifestyle Modifications (70-85% of GDM cases can be managed with this alone)
   • Medical nutrition therapy with a registered dietitian
   • Physical activity
   • Weight management
   • Blood glucose monitoring with targets:
     • Fasting glucose <95 mg/dL (<5.3 mmol/L)
     • One-hour postprandial glucose <140 mg/dL (<7.8 mmol/L) or
     • Two-hour postprandial glucose <120 mg/dL (<6.7 mmol/L)

When Pharmacotherapy is Needed

If glycemic targets are not achieved with lifestyle modifications alone, pharmacological intervention is required:

1. Insulin is the preferred medication for treating hyperglycemia in GDM 1

   • Does not cross the placenta
   • Has the best safety profile
   • Can be titrated precisely to achieve glycemic targets

2. Oral Agents (Not First-Line)

   • Metformin and glyburide should not be used as first-line agents 1
   • Both cross the placenta to the fetus
   • Lack long-term safety data
   • Glyburide may be associated with increased rates of neonatal hypoglycemia and macrosomia 1

Why Jardiance (Empagliflozin) is Not Recommended

1. No Safety Data in Pregnancy

   • SGLT2 inhibitors like empagliflozin are not mentioned in any of the current guidelines for GDM management
   • No clinical trials have established safety or efficacy in pregnancy

2. Current Guidelines Explicitly Limit Options

   • The 2024 American Diabetes Association Standards of Care specifically states that insulin is the preferred medication for GDM 1
   • Other oral and non-insulin injectable glucose-lowering medications (which would include SGLT2 inhibitors) lack long-term safety data 1

3. Potential Risks

   • SGLT2 inhibitors work by increasing urinary glucose excretion, which could potentially affect maternal-fetal glucose dynamics
   • Risk of volume depletion, urinary tract infections, and ketoacidosis could be problematic during pregnancy

Clinical Decision Algorithm for GDM Management

1. Initial Management: Start with lifestyle modifications (medical nutrition therapy, physical activity)

   • Monitor blood glucose 4-7 times daily (fasting and 1-2 hours postprandial)
   • Continue if glycemic targets are met

2. If Glycemic Targets Not Met After 1-2 Weeks:

   • Add insulin therapy (not Jardiance or other oral agents)
   • Start with small doses and titrate as needed

3. Insulin Regimen:

   • Initially, a small proportion as basal insulin
   • Greater proportion as prandial insulin
   • Frequent titration necessary due to changing insulin requirements throughout pregnancy

Important Considerations

• Telehealth visits for GDM have been shown to improve outcomes compared with standard in-person care 1
• Regular glucose monitoring is essential regardless of treatment approach
• Delayed insulin initiation should be avoided as poor glycemic control increases risks of adverse maternal and fetal outcomes 2

Post-Pregnancy Considerations

For women with history of GDM who are breastfeeding:

• Insulin remains the safest option during breastfeeding 2
• Some oral agents (metformin, glyburide, glipizide) may be considered during breastfeeding 2
• SGLT2 inhibitors like Jardiance may be considered for prevention of type 2 diabetes after breastfeeding is completed, but not during pregnancy or lactation 3

In summary, Jardiance has no place in the management of GDM. Insulin remains the gold standard pharmacological treatment when lifestyle modifications are insufficient.