Enhance Study: Evaluation of Accuracy and Safety of the Eversense CGM System With Enhanced Features

Inclusion Criteria: Subjects meeting all of the following inclusion criteria will be included in this study:

1. Subjects ≥14 years of age
2. Clinically confirmed diagnosis of diabetes mellitus for ≥1 year for adults 18 yearsand older
3. Clinically confirmed diagnosis of type I diabetes mellitus for ≥1 year for adolescents 14 -17 years old
4. Subject has signed an informed consent or assent form and parent/guardian has signedan informed consent, as applicable, and subject is willing to comply with protocolrequirements.

Exclusion Criteria: Subjects meeting any of the following exclusion criteria at the time of screening will beexcluded from this study:

1. History of unexplained severe hypoglycemia in the previous 6 months. Severehypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure.
2. History of diabetic ketoacidosis requiring emergency room visit or hospitalization inthe previous 6 months.
3. Subjects with gastroparesis.
4. Female subjects of childbearing capacity (defined as of child bearing age and as notsurgically 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 thestudy.
5. A condition preventing or complicating the placement, operation, or removal of thesensor or wearing of transmitter, including upper extremity deformities or skincondition.
6. Symptomatic coronary artery disease; unstable angina; myocardial infarction, transientischemic attack or stroke in the past 6 months; uncontrolled hypertension (systolic>160 mm Hg or diastolic >100 mm Hg at time of screening); current congestiveheart failure; history of cardiac arrhythmia (benign PACs and PVCs allowed). Subjectswith asymptomatic coronary artery disease (e.g., CABG, stent placement or angioplasty)may participate if negative stress test within 1 year prior to screening and writtenclearance from Cardiologist documented.
7. Hematocrit <38% or >60% at screening
8. History of hepatitis B, hepatitis C, or HIV
9. Current treatment for a seizure disorder unless written clearance by neurologist toparticipate in study.
10. History of adrenal insufficiency
11. Currently receiving (or likely to need during the study period): immunosuppressanttherapy; chemotherapy; anticoagulant/antithrombotic therapy (excluding aspirin);topical glucocorticoids over sensor site only; antibiotic for chronic infection (e.g.,osteomyelitis, endocarditis)
12. For subjects inserted with the ROME CGM System: A condition requiring or likely torequire 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 tocomplete the study or would make it not in the subject's best interest to participatein the study. Conditions include but are not limited to psychiatric conditions, knowncurrent or recent alcohol abuse or drug abuse by subject history, a condition that mayincrease 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 priorto screening or intent to participate during the study period
17. The presence of any other active implanted device (as defined further in protocol)