INSULIN,DEGLUDEC,HUMAN 100 UNIT/ ML
Clinical Criteria Summary
Exclusion Criteria
- Hypersensitivity to insulin degludec
Inclusion Criteria – Insulin Degludec 100 u/mL Only
- Instability of glucose levels (e.g., insulin-sensitive type 1 diabetes) resulting in hypoglycemia while receiving lower doses of insulin glargine 100 units/mL
- Wide fluctuation in glucose levels due to an inability to take basal insulin at a consistent time (e.g., variability in shift work, dialysis, inconsistent routines), documented in the Federal EHR
- Fluctuation in glucose levels must be documented in a glucose diary or continuous glucose monitor (CGM) and included in the Federal electronic health record (EHR)
Inclusion Criteria – Insulin Degludec 200 u/mL Only
- Insulin resistance (e.g., requires >1 unit/kg/day)
- Recurrent episodes of hypoglycemia on insulin glargine 100 u/mL (e.g., > three Level 2 or one Level 3 hypoglycemic event within a one-month period) despite use of CGM and adjustments made to current insulin regimen
Product Specifications & Clinical Definitions
- Concentrated degludec 200 u/mL can be given in 2-unit increments, delivering up to 160 units per single injection; preferred for patients who are insulin resistant receiving high doses of insulin
- Degludec 100 u/mL can be given in 1-unit increments, delivering up to 80 units per single injection
- Level 2 hypoglycemia: glucose level <54 mg/dL
- Level 3 hypoglycemia: severe event requiring assistance for management, regardless of glucose level
- CGM: Continuous glucose monitor