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INSULIN INHL,ORAL

Clinical Criteria Summary

Pre-Considerations & Prerequisites

  • • Patient training with a VA Diabetes Educator
  • • Offer a trial of insulin pens, smaller gauge needles, and other assistive devices
  • • Patient must demonstrate competency with and agree to self-monitoring of blood glucose
  • • If basal insulin is required, conversion from pre-meal inhaled to injectable insulin should occur once the patient is stabilized on basal insulin and comfortable with administering injections

Exclusion Criteria

  • • COPD, asthma, or other chronic lung disorders
  • • Patients who smoke or have recently quit smoking within the last six months
  • • Active lung cancer, prior history of lung cancer, or risk factors (other than smoking) for lung cancer
  • • History of a serious hypersensitivity reaction to regular human insulin or excipients of Afrezza
  • • Treatment of diabetic ketoacidosis

Inclusion Criteria

  • • Patient has diabetes and requires insulin (inhaled insulin must be used in combination with long-acting insulin in patients with type 1 diabetes)
  • • Provider is experienced in managing insulin therapy in patients with diabetes (e.g., endocrinologists, diabetologists, practices in a diabetes management team)
  • • Patient must have baseline spirometry (FEV1) within the last 6 months to identify potential underlying lung disease
  • • AND at least one of the following:
  • Severe persistent injection site reactions (e.g., lipohypertrophy)
  • Works in an environment that does not allow needles

Special Circumstances

  • • Psychological aversion to needles may warrant case-by-case consideration for inhaled insulin use

Source Documents