A Performance Evaluation of the Harmony 1 Sensors in Adults and Pediatrics

Exclusion Criteria

• •Subject will not tolerate tape adhesive in the area of Harmony 1 Sensor placement as assessed by qualified individuals
• •Subject has any unresolved adverse skin condition in the area of Harmony 1 Sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
• •Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
• •Subject is female and has a positive pregnancy screening test
• •Females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by investigator
• •Subject is female and plans to become pregnant during the course of the study
• •Subject has had a hypoglycemic seizure within the past 6 months
• •Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit
• •Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit.
• •Subject has a history of a seizure disorder
• •Subject has central nervous system or cardiac disorder resulting in syncope
• •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
• •Subject has a hematocrit (Hct) lower than the normal reference range
• •Subject has a history of adrenal insufficiency