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

Inclusion Criteria: * Subject is 2-75 years of age at time of screening * A clinical diagnosis of type 1 or 2 diabetes for a minimum of 12 months duration as determined via medical record or source documentation by an individual qualified to make a medical diagnosis * Adequate venous access as assessed by investigator or appropriate staff * Subjects participating in the high and low glucose challenges must have an established insulin carbohydrate ratio(s) and insulin sensitivity ratio. (The term "established" refers to a ratio that has been previously defined and tested prior to screening visit). Subjects without established ratios may participate under observation only. 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