Afrezza With Basal Combination (ABC)

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Diabetes Mellitus, Insulin, Inhaled Insulin, Afrezza, Technosphere Insulin Read More

Inclusion Criteria:

• Subjects ≥18 years of age at the time of signing the informed consent form
• Clinical diagnosis of Type 1 Diabetes
• HbA1c ≥7.0% and <11.0%
• Treatment with a CSII pump with an AID algorithm (Medtronic 670G/770G or Tandem Control IQ) for at least 3 months
• Ability to pay for their own RAA used in the insulin pump or injections, either through co-pay or self-pay, for the duration of the study
• Willingness to follow study procedures including discontinuing their insulin pump and transitioning to insulin degludec injections plus Afrezza

Exclusion Criteria:

• A recent history of asthma (defined as using any medications to treat within the last year), chronic obstructive pulmonary disease (COPD), or any other clinically important pulmonary disease (e.g., cystic fibrosis, bronchopulmonary dysplasia), or significant congenital or acquired cardiopulmonary disease
• History of serious complications of diabetes (e.g., active proliferative retinopathy or symptomatic autonomic neuropathy)
• History of hypersensitivity to insulin or any of the Afrezza excipients
• On dialysis
• Respiratory tract infection within 14 days before screening (subject may return 14 days after resolution of symptoms for rescreening)
• Exposure to any investigational drug in the past 30 days or an investigational device in the past 2 weeks
• Adrenal insufficiency, active use of steroids or planned steroid use
• Hypothyroidism not controlled, as defined by thyroid stimulating hormone (TSH) outside the upper limit of the reference range by >1.5 × in the last 6 months, according to the local laboratory reference range
• Hyperthyroidism not controlled, as defined by TSH below the normal reference range, according to the local laboratory
• Use of antiadrenergic drugs (e.g., beta blockers and clonidine)
• Any concurrent illness (other than diabetes mellitus) not controlled by a stable therapeutic regimen
• History of a significant eating disorder (e.g., anorexia or bulimia nervosa)
• Current drug or alcohol abuse or a history of drug or alcohol abuse that, in the opinion of the Investigator or the Sponsor, would make the subject an unsuitable candidate for participation in the study
• History of smoking (includes cigarettes, cigars, pipes, vaping devices, and marijuana) in the 6 months before screening
• Female subject who is pregnant, breast-feeding, intends to become pregnant, or is of child-bearing potential and not using adequate contraceptive methods as required by local regulation or practice (may include sexual abstinence)
• An event of severe hypoglycemia, as reported by the patient, within the last 180 days before screening
• An episode of diabetic ketoacidosis (DKA), as determined by the Investigator, requiring hospitalization within the last 180 days before screening
• Exposure to Afrezza in the 30 days before screening
• Abnormal TSH or creatinine levels above 2.0 mg/dL