Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System

Exclusion Criteria

• •1. Subject has a history of 1 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
• •2. Subject has been hospitalized or has visited the ER in the 6 months prior to Screening resulting in a primary diagnosis of uncontrolled diabetes
• •3. Subject has had Diabetic Ketoacidosis (DKA) in the 6 months prior to Screening.
• •4. Subject has Hypoglycemia Unawareness, as measured by the Gold questionnaire (Gold, MacLeod et al. 1994) at Screening
• •5. Subject is unable to tolerate tape adhesive in the area of sensor placement
• •6. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
• •7. Women of child-bearing potential who have a positive pregnancy test at Screening or plan to become pregnant during the course of the study
• •8. 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.
• •9. Subject 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
• •10. Subject is being treated for hyperthyroidism at time of Screening
• •11. Subject has a diagnosis of adrenal insufficiency
• •12. Subject has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of Screening, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study
• •13. Subject 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
• •14. Subject is currently abusing illicit drugs
• •15. Subject is currently abusing marijuana
• •16. Subject is currently abusing prescription drugs
• •17. Subject is currently abusing alcohol
• •18. Subject is using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of Screening
• •19. Subject 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
• •20. Subject has elective surgery planned that requires general anesthesia during the course of the study
• •21. Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of Screening
• •22. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
• •23. Subject diagnosed with current eating disorder such as anorexia or bulimia
• •24. Subject has been diagnosed with chronic kidney disease that results in chronic anemia
• •25. Subject has a hematocrit that is below the normal reference range of lab used.
• •26. Subject is on dialysis
• •27. Subject has serum creatinine of \>2 mg/dL.
• •28. Research staff involved with the study.