Hybrid Closed Loop Pivotal Trial in Type 1 Diabetes

Exclusion Criteria

• •1. Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening:
• •* Medical assistance (i.e. Paramedics, Emergency Room ( ER) or Hospitalization)
• •* Coma
• •* Seizures
• •2. Is unable to tolerate tape adhesive in the area of sensor placement
• •3. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
• •4. Females who are sexually active and able to conceive will be excluded if they are not using an effective method of contraception and do not agree to continue using an effective method of contraception for the duration of the study as determined by investigator.
• •5. 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, ventricular rhythm disturbances or thromboembolic disease
• •6. Is being treated for hyperthyroidism at time of screening
• •7. Has diagnosis of adrenal insufficiency
• •8. Has had DKA in the 6 months prior to screening visit.
• •9. Has taken any oral, injectable, or intravenous (IV) steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study
• •10. 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
• •11. Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes
• •12. Currently abusing illicit drugs
• •13. Currently abusing marijuana.
• •14. Currently abusing prescription drugs
• •15. Currently abusing alcohol
• •16. Using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening
• •17. 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
• •18. Has elective surgery planned that requires general anesthesia during the course of the study
• •19. Has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
• •20. Plans to receive red blood cell transfusion or erythropoietin over the course of study participation
• •21. Diagnosed with current eating disorder such as anorexia or bulimia
• •22. Diagnosed with chronic kidney disease that results in chronic anemia
• •23. Hematocrit that is below the normal reference range of lab used.
• •24. On dialysis
• •25. Serum creatinine of \>2 mg/dL.