Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics

Exclusion Criteria

• •1. Subject will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
• •2. Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection).
• •3. Subject is actively participating in an investigational study (e.g., drug or device) wherein he/she has received treatment from an investigational study (drug or device) in the last 2 weeks prior to Visit 1. (Please note participation in an observational study is acceptable.)
• •4. Subject is female of child-bearing potential and has a pregnancy screening test that is positive.
• •5. Subject is a sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by investigator.
• •6. Subject is female and plans to become pregnant during the course of the study.
• •7. Subject has had a hypoglycemic seizure within the past 6 months prior to enrollment.
• •8. Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to enrollment.
• •9. Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to enrollment.
• •10. Subject has a history of a seizure disorder.
• •11. Subject has central nervous system or cardiac disorder resulting in syncope.
• •12. Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
• •13. If subject is 7-80 years of age, subject has a hematocrit (Hct) more than 10% below the lower limit of normal reference range (please note that patients may use prior blood draw from routine care as long as done within 6 months of screening and report of lab placed with subject source documents).
• •14. Subject has a history of adrenal insufficiency.
• •15. Subject is a member of the research staff involved with the study.