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

This study is a multi-center, randomized, prospective single-sample correlational design
without controls. A total of up to 310 previously-diagnosed type 1 or 2 diabetes subjects
will be enrolled in order to have 160 subjects complete frequent sample testing at up to 17
centers. Subjects will wear Harmony 1 sensors used with the Guardian Mobile application.

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