Enhance Study: Evaluation of Accuracy and Safety of the Eversense CGM System With Enhanced Features
Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
About this trial
This is an interventional diagnostic trial for Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
Subjects meeting all of the following inclusion criteria will be included in this study:
- Subjects greater than or equal to18 years of age
- Clinically confirmed diagnosis of diabetes mellitus for greater than or equal to 1 year.
- Subject has signed an informed consent form and is willing to comply with protocol requirements
Exclusion Criteria:
Subjects meeting any of the following exclusion criteria at the time of screening will be excluded from this study:
- History of unexplained severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure
- History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
- Subjects with gastroparesis
- Female subjects of childbearing capacity (defined as not surgically sterile or not menopausal for greater than 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study
- A condition preventing or complicating the placement, operation or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition
- Symptomatic coronary artery disease; unstable angina; myocardial infarction, transient ischemic attack or stroke within 6 months; uncontrolled hypertension (systolic greater than 160 mm HG or diastolic greater than100 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.
- Hematocrit less than 38% or greater than 60% at screening
- History of hepatitis B, hepatitis C, or HIV
- Current treatment for a seizure disorder unless written clearance by neurologist to participate in study
- History of adrenal insufficiency
Currently receiving (or likely to need during the study period): immunosuppressant therapy; chemotherapy; anticoagulant/antithrombotic therapy (excluding aspirin); topical glucocorticoids over sensor site only; antibiotics for chronic infection (e.g.
osteomyelitis, endocarditis)
- Known topical or local anesthetic allergy
- Known allergy to glucocorticoids
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
- Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during the study period
- The presence of any other active implanted device
Sites / Locations
- AMCR Institute Inc.Recruiting
- Rocky Mountain Diabetes Center, LLC. (RMDC)Recruiting
- Clinical Trials of Texas, LLC. (CTT)Recruiting
- Rainier Clinical Research CenterRecruiting
Arms of the Study
Arm 1
Experimental
Continuous Glucose Monitoring Device
Eversense 524 CGM System and ROME CGM System.