Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Diabetes
• Age: Between 4 Year(s) - 18 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Assent from the pediatric subject, as appropriate, and fully informed consent from the parent(s) or legal guardian
  2. Clinical diagnosis of Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) (per the Investigator) and have been using insulin for at least 6 months for T1DM, or at least 3 months for T2DM
  3. Treatment with basal-bolus insulin therapy delivered by multiple daily injections for at least 2 weeks:
     • Acceptable bolus insulins are restricted to the RAAs insulin lispro or insulin aspart, including biosimilar products
     • Basal insulins are restricted to 100 U/mL formulations of insulin glargine or insulin degludec, including biosimilar products
  4. Access to stable WiFi connection
  5. Hemoglobin A1c (HbA1c) =7.0% and =11.0%

  
  

You may not be eligible for this study if the following are true:

• 1. History of recent blood transfusions (within previous 3 months), hemoglobinopathies, or any other conditions that affect HbA1c measurements
  2. History of asthma, any other clinically important pulmonary disease (e.g., cystic fibrosis or bronchopulmonary dysplasia), use of any medications to treat such conditions within the last year, or significant congenital or acquired cardiopulmonary disease
  3. History of serious complications of diabetes (e.g., active proliferative retinopathy or symptomatic autonomic neuropathy), or likely need for specific treatment for diabetic retinopathy (laser photocoagulation, vitrectomy, other) in the next year.
  4. FEV1 and FEV1/forced vital capacity (FVC) =80% of predicted Global Lung Function Initiative (GLI) value
  5. Respiratory tract infection within 14 days before screening or between the screening and randomization visits (subject may return 14 days after resolution of symptoms for rescreening)
  6. Inability or unwillingness to perform study procedures
  7. Exposure to any investigational product(s), including drugs or devices, in the past 30 days
  8. Any disease other than diabetes or exposure to any medication that, in the judgment of the Investigator, may impact glucose metabolism
  9. Use of antiadrenergic drugs
  10. Any concurrent illness (other than diabetes mellitus) not controlled by a stable therapeutic regimen
  11. History of a significant eating disorder
  12. Current drug or alcohol abuse or a history of drug or alcohol abuse
  13. Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) for the preceding 6 months and/or positive cotinine test for smoking
  14. Female subject who is pregnant, breast-feeding, intends to become pregnant, or is of child-bearing potential, sexually active and not using adequate contraceptive methods as required by local regulation or practice
  15. An event of severe hypoglycemia, as judged by the Investigator, within the last 90 days prior to screening
  16. An episode of diabetic ketoacidosis (DKA) requiring hospitalization within the last 90 days prior to screening