Effect of Inhaled Technosphere Insulin vs RAA Insulin on Exercise-Induced Hypoglycemia in Adults With T1D Using Automated Insulin Delivery

Exclusion Criteria

• •1. Use of inhaled insulin within one week prior to screening visit
• •2. History of asthma, chronic obstructive pulmonary disease (COPD), or any other clinically important pulmonary disease (e.g., cystic fibrosis or bronchopulmonary dysplasia), or significant congenital or acquired cardiopulmonary disease as judged by the Investigator
• •3. Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) within 90 days prior to screening visit and no plans to smoke during the study
• •4. History or current diagnosis of lung cancer
• •5. Forced expiratory volume in 1 second (FEV1) measurement of \<70% of predicted Global Lung Function Initiative value
• •6. Pregnant or lactating, planning to become pregnant during the study, or is of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD, or implant); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal)
• •• A pregnancy test is required for any person of childbearing potential.
• •7. An event of severe hypoglycemia, as judged by the Investigator, within the 90 days prior to screening visit
• •8. An episode of diabetic ketoacidosis (DKA) as defined in section 5.2 within the 90 days prior to screening visit
• •9. Any disease other than diabetes or current use (or anticipated use during the study) of any medication (e.g., beta blocker) that, in the judgment of the Investigator, may substantially impact glucose metabolism
• •10. Use of a non-insulin glucose-lowering medication (or weight-reduction medication with glucose-lowering effect) within 4 weeks prior to screening visit
• •11. Exposure to any investigational drug in the 90 days prior to the screening visit
• •12. Current or anticipated acute uses of oral, inhaled, or injectable glucocorticoids during the time period of the study (topical or intranasal glucocorticoid use is acceptable)
• •13. Current use of Hydroxyurea medication
• •14. Current or anticipated use of a low carbohydrate diet (\<50 grams/day) or low calorie diet (\<800 kcal/day) during the time period of the study
• •15. Current treatment for diabetic retinopathy
• •16. Known stage 4/5 chronic kidney disease or on dialysis
• •17. Having a direct supervisor at place of employment who is directly involved in conducting the clinical trial (as a study Investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the study