Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp®

Exclusion Criteria

• •1. Has hypersensitivity to insulin aspart or one of the excipients in Fiasp.
• •2. Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening:
• •1. Medical assistance (i.e., Paramedics, Emergency Room \[ER\] or Hospitalization)
• •2. Coma
• •3. Seizures
• •3. Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes.
• •4. Has had DKA in the last 6 months prior to screening visit.
• •5. Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
• •6. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
• •7. Is female of child-bearing potential and result of pregnancy test is positive at screening.
• •8. Is sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by the investigator.
• •9. Is female and plans to become pregnant during the course of the study.
• •10. Is being treated for hyperthyroidism at time of screening.
• •11. Has diagnosis of adrenal insufficiency.
• •12. Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study.
• •13. Is using hydroxyurea at time of screening or plans to use it during the study.
• •14. Is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks.
• •15. Is currently abusing illicit drugs.
• •16. Is currently abusing marijuana.
• •17. Is currently abusing prescription drugs.
• •18. Is currently abusing alcohol.
• •19. Using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening.
• •20. Has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator.
• •21. Has elective surgery planned that requires general anesthesia during the course of the study.
• •22. Has sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.
• •23. Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
• •24. Is diagnosed with current eating disorder such as anorexia or bulimia.
• •25. Has been diagnosed with chronic kidney disease that results in chronic anemia.
• •26. Has a hematocrit that is below the normal reference range of lab used.
• •27. Is on dialysis.
• •28. Has serum creatinine of \>2 mg/dL.
• •29. Has celiac disease that is not adequately treated as determined by the investigator.
• •30. Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.
• •31. Has had history of cardiovascular event 1 year or more from the time of screening without
• •1. a normal EKG and stress test within 6 months prior to screening or during screening or
• •2. clearance from a qualified physician prior to receiving the study devices if there is an abnormal EKG or stress test.
• •32. Has 3 or more cardiovascular risk factors listed below without a normal EKG within 6 months prior to screening or during screening or clearance from a qualified physician if there is an abnormal EKG:
• •* Age \>35 years
• •* Type 1 diabetes of \>15 years' duration
• •* Presence of any additional risk factor for coronary artery disease
• •* Presence of microvascular disease (proliferative retinopathy or nephropathy, including microalbuminuria)
• •* Presence of peripheral vascular disease
• •* Presence of autonomic neuropathy
• •33. Is a member of the research staff involved with the study.
• •34. Has used a MiniMed 780G pump prior to screening.