Evaluation of Medtronic DUO Extended Set

Exclusion Criteria

• •1. 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.
• •2. Subject is female and has a positive pregnancy screening test.
• •3. Subject is female of childbearing age and who is sexually active should be excluded if she is not using a form of contraception deemed reliable by investigator.
• •4. Subject is female and plans to become pregnant during the study.
• •5. Subject has Glycosylated hemoglobin (HbA1c) \> 8.5 % at time of screening.
• •6. Subject has had a history of 1 or more episodes of severe hypoglycemia.
• •7. Subject has taken any oral, injectable, or 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.
• •8. Subject is unable to tolerate tape adhesive in the area of Duo™ Extended set or sensor.
• •9. Subject has any unresolved adverse skin condition, including infection, in the area of Duo™ Extended set or sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
• •10. Subject has had Diabetic Ketoacidosis (DKA) in the 12 months prior to screening visit.
• •11. Subject is currently abusing illicit drugs.
• •12. Subject is currently abusing alcohol.
• •13. Subject has history of adrenal disorder.
• •14. Subject has a history of inpatient psychiatric treatment in the past 6 months prior to screening.
• •15. Subject has any condition that the Investigator believes would interfere with study participation.
• •16. 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.
• •17. Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.
• •18. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
• •19. Subject is using pramlintide (Symlin), SGLT2 inhibitors, GLP agonists, biguanides, DPP-4 inhibitors or sulfonylureas more than 2 weeks from time of screening.
• •20. Subject has been diagnosed with chronic kidney disease, having an estimated glomerular filtration rate (eGFR)\< 60mL/min/1.73 m2, requiring dialysis, or resulting in chronic anemia.
• •21. Subject has history of cardiovascular disease defined as any ischemic related event or clinically significant arrythmia.
• •22. Subject has hypothyroidism and has out of reference range thyroid-stimulating hormone (TSH) on screening visit.
• •23. Subject plans to have medical imagining (e.g., MRI, diathermy services, CT scans, etc.) over the course of the study.