Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mannkind Corporation
With
Jaeb Center for Health Research
Age
4–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Assent from the pediatric subject, as appropriate, and fully informed consent from the parent(s) or legal guardian, as required by both state and federal laws and the local Institutional Review Board (IRB)
Subjects ≥4 and \<18 years of age
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
Treatment with basal-bolus insulin therapy delivered by multiple daily injections for at least 2 weeks
Bolus insulins are restricted to the RAAs insulin lispro, insulin aspart or insulin glulisine, including biosimilar products
Basal insulins are restricted to insulin glargine, insulin degludec or insulin detemir, including biosimilar products
Access to stable WiFi connection
HbA1c ≥7.0% and ≤11%
Average prandial dose of insulin ≥2 units per meal
Utilized CGM for ≥70% of the time over a consecutive 14-day period preceding randomization
You may not be if
History of recent blood transfusions (within previous 3 months), hemoglobinopathies, or any other conditions that affect HbA1c measurements
Recent history of asthma (defined as using any medications to treat within the last year), any other clinically important pulmonary disease (e.g., cystic fibrosis or bronchopulmonary dysplasia), or significant congenital or acquired cardiopulmonary disease
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
FEV1 and FEV1/forced vital capacity (FVC) ≤80% of predicted Global Lung Function Initiative (GLI) value
Inability to achieve an acceptable FEV1 and FVC reading for subjects ≥8 years of age would make the subject ineligible
For subjects \<8 years of age who are unable to achieve an acceptable FVC reading, FEV1 only may be assessed; inability to achieve an acceptable FEV1 would make the subject ineligible
Respiratory tract infection within 14 days before screening (subject may return 14 days after resolution of symptoms for rescreening)
Inability or unwillingness to perform study procedures
Exposure to any investigational product(s), including drugs or devices, in the past 30 days
Any disease other than diabetes or exposure to any medication that, in the judgment of the Investigator, may impact glucose metabolism and current or anticipated acute uses of glucocorticoids or weight loss medications, with the exception of metformin and/or GLP-1 agonists (if GLP-1 agonists used for at least the 3 months prior to enrollment) in subjects with T2DM
Use of antiadrenergic drugs (e.g., clonidine)
Any concurrent illness (other than diabetes mellitus) not controlled by a stable therapeutic regimen
Current uncontrolled 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
Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) for the preceding 6 months and/or positive urine cotinine test
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
An event of severe hypoglycemia, as judged by the Investigator, within the last 90 days prior to screening
An episode of DKA requiring hospitalization within the last 90 days prior to screening
Clareo Health | Afrezza® INHALE-1 Study in Pediatrics
