Evaluation of the Accuracy of an Implanted Glucose Sensor

Inclusion Criteria:

1. Adult subjects, age ≥18 years

2. Clinically confirmed diagnosis of diabetes mellitus for ≥1 year

3. Subject has signed an informed consent form and is willing to comply with protocol
requirements

Exclusion Criteria:

1. History of severe hypoglycemia in the previous 6 months. Severe hypoglycemia is
defined as hypoglycemia resulting in loss of consciousness or seizure

2. History of diabetic ketoacidosis requiring emergency room visit or hospitalization in
the previous 6 months

3. Female subjects of childbearing capacity (defined as not surgically sterile or not
menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant,
or not practicing birth control during the course of the study.

4. A condition preventing or complicating the placement, operation, or removal of the
Sensor or wearing of transmitter, including upper extremity deformities or skin
condition.

5. Symptomatic coronary artery disease; unstable angina; myocardial infarction, transient
ischemic attack or stroke in the past 6 months; uncontrolled hypertension
(systolic>160 mm Hg or diastolic >100 mm Hg at time of screening); current congestive
heart failure; history of cardiac arrhythmia (benign PACs and PVCs allowed). Subjects
with asymptomatic coronary artery disease (e,g, CABG, stent placement or angioplasty)
may participate if negative stress test within 1 year prior to screening and written
clearance from Cardiologist documented.

6. Hematocrit <30% or >55%

7. History of hepatitis B, hepatitis C, or HIV

8. Any condition that in the investigator's opinion would make the subject unable to
complete the study or would make it not in the subject's best interest to participate
in the study.