What medications are approved for treating childhood diabetes, including type 1 (T1D) and type 2 (T2D) diabetes?

FDA-Approved Medications for Childhood Diabetes

For childhood diabetes, insulin therapy is essential for type 1 diabetes, while type 2 diabetes can be treated with insulin, metformin, GLP-1 receptor agonists, and empagliflozin, with treatment selection based on clinical presentation and diabetes type. 1, 2

Type 1 Diabetes Medications

Insulin (First-line therapy)

Insulin is the cornerstone of treatment for all children with type 1 diabetes, as it is essential for survival 1. The goal is to mimic normal physiological insulin secretion patterns through:

• Rapid-acting insulin analogs (for mealtime/bolus dosing):

  • Aspart (Novolog): onset 0.25-0.5h, peak 1-3h, duration 3-5h
  • Lispro (Humalog): onset 0.25-0.5h, peak 1-3h, duration 3-5h
  • Glulisine (Apidra): onset 0.25-0.5h, peak 1-3h, duration 3-5h

• Short-acting insulin:

  • Regular insulin: onset 0.5-1h, peak 2-4h, duration 5-8h

• Intermediate-acting insulin:

  • NPH: onset 2-4h, peak 4-8h, duration 12-18h

• Long-acting insulin analogs (for basal dosing):

  • Detemir (Levemir): onset 2-4h, no peak, duration 12-24h
  • Glargine (Lantus, Basaglar, Toujeo): onset 2-4h, no peak, duration up to 24h
  • Degludec (Tresiba): onset 2-4h, no peak, duration >24h

Insulin delivery methods include:

1. Multiple daily injections (MDI): Combination of basal and bolus insulin
2. Continuous subcutaneous insulin infusion (CSII/insulin pump): Provides 24-hour adjustable basal rates plus patient-activated mealtime boluses 3

Adjunctive Therapies for Type 1 Diabetes

There is insufficient evidence to support routine use of adjunctive medical therapies in children with type 1 diabetes 1. Metformin has been studied in overweight/obese adolescents with type 1 diabetes but has not shown glycemic benefit, though some studies showed weight loss and/or reductions in insulin requirements 1.

Type 2 Diabetes Medications

FDA-Approved Medications for Pediatric Type 2 Diabetes:

1. Metformin (First-line oral therapy):

   • Approved for children ≥10 years old
   • Initial dose: Start low and titrate up to 2,000 mg daily as tolerated
   • Contraindicated in renal impairment, should be temporarily discontinued with IV contrast procedures 4

2. Insulin (Required in specific scenarios):

   • Required for children presenting with:
     • Ketosis or diabetic ketoacidosis
     • Random blood glucose ≥250 mg/dL
     • HbA1c ≥8.5% (69 mmol/mol)
     • When distinction between type 1 and type 2 diabetes is unclear 1

3. GLP-1 Receptor Agonists:

   • Consider adding for children ≥10 years old if glycemic targets not met with metformin
   • Contraindicated in patients with family history of medullary thyroid carcinoma 1

4. Empagliflozin (SGLT-2 inhibitor):

   • Recently approved for youth with type 2 diabetes
   • Demonstrated significant A1C reduction (0.84%) compared to placebo 1

Treatment Algorithm

For Type 1 Diabetes:

1. Initial therapy: Intensive insulin regimen via either:

   • Multiple daily injections of prandial insulin and basal insulin
   • Continuous subcutaneous insulin infusion (insulin pump)
   • Target HbA1c <7.5% 1, 2

2. Monitoring:

   • Blood glucose monitoring multiple times daily (6-10 times/day)
   • Consider continuous glucose monitoring (CGM)
   • A1C measurement every 3 months 1

For Type 2 Diabetes:

1. For patients with A1C <8.5% without acidosis/ketosis:

   • Start with metformin (if ≥10 years old)
   • Titrate up to 2,000 mg daily as tolerated 1

2. For patients with A1C ≥8.5%, ketosis, or blood glucose ≥250 mg/dL:

   • Start with insulin therapy
   • Add metformin after resolution of ketosis
   • If on insulin and meeting glucose targets, insulin can be tapered over 2-6 weeks 1

3. If glycemic targets not met with metformin:

   • Add GLP-1 receptor agonist (if ≥10 years old)
   • Consider empagliflozin
   • Add/intensify insulin therapy if needed 1

Important Clinical Considerations

• Distinguishing between type 1 and type 2 diabetes can be challenging, especially in overweight/obese adolescents. Measurement of islet autoantibodies and C-peptide is recommended 1

• Monogenic diabetes accounts for approximately 1.2-4% of pediatric diabetes and is frequently misdiagnosed as type 1 diabetes. Consider this diagnosis in antibody-negative youth with diabetes 1

• For children with type 1 diabetes, insulin therapy is non-negotiable and lifelong 5, 6

• For children with type 2 diabetes, metformin is not approved for children <10 years old 4

• Medications not approved by the FDA for youth with type 2 diabetes should not be used outside of research trials 1

• Comprehensive diabetes education, including medical nutrition therapy and exercise guidance, is essential for all children with diabetes 1