PROMISE Study: An Evaluation of an Implantable Continuous Glucose Sensor up to 180 Days

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 unexplained 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. Subjects with gastroparesis

4. 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.

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

6. 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.

7. Hematocrit <30% or >60%

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

9. Current treatment for a seizure disorder unless written clearance by neurologist to
participate in study

10. History of adrenal insufficiency

11. Currently receiving (or likely to need during the study period): immunosuppressant
therapy; chemotherapy; anticoagulant/antithrombotic therapy (excluding aspirin);
glucocorticoids (excluding ophthalmic or nasal). This exclusion does include the use
of inhaled glucocorticoids and the use of topical glucocorticoids (over sensor site
only); antibiotic for chronic infection (e.g. osteomyelitis, endocarditis)

12. A condition requiring or likely to require magnetic resonance imaging (MRI)

13. Known topical or local anesthetic allergy

14. Known allergy to glucocorticoids

15. 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. Conditions include but are not limited to psychiatric conditions, known
current or recent alcohol abuse or drug abuse by subject history, a condition that may
increase the risk of induced hypoglycemia or risk related to repeated blood testing.
Investigator will supply rationale for exclusion

16. Participation in another clinical investigation (drug or device) within 2 weeks prior
to screening or intent to participate during the study period

17. The presence of any other active implanted device (as defined further in protocol)