A Feasibility Study to Evaluate the Performance of the Harmony 1 Sensors in Adults and Pediatrics

The study is a multi-center, prospective single-sample correlational design without
controls.

Inclusion Criteria:

1. Subject is 14 - 75 years of age at time of screening

2. A clinical diagnosis of type 1 or 2 diabetes for a minimum of 6 months duration as
determined via medical record or source documentation by an individual qualified to
make a medical diagnosis

3. Adequate venous access as assessed by investigator or appropriate staff

Exclusion Criteria:

1. Subject will not tolerate tape adhesive in the area of Harmony 1 Sensor placement as
assessed by qualified individual.

2. Subject has any unresolved adverse skin condition in the area of Harmony 1 Sensor or
device placement (e.g., psoriasis, rash, Staphylococcus infection)

3. 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

4. Subject is female and has a positive pregnancy screening test

5. 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

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

8. Subject has had hypoglycemia resulting in loss of consciousness within the past 6
months prior to screening visit.

9. Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months
prior to screening visit.

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. Subject has a hematocrit (Hct) lower than the normal reference range

14. Subject has a history of adrenal insufficiency.