Enhance Study: Evaluation of Accuracy and Safety of the Eversense CGM System With Enhanced Features
Study Details
Study Description
Brief Summary
A Prospective, Multicenter Evaluation of Accuracy and Safety of the Eversense CGM System with Enhanced Features. The purpose of this clinical investigation is to evaluate the accuracy of the Eversense 524 Continuous Glucose Monitoring System (Eversense 524 CGM System) with next generation feature enhancements compared to reference glucose measurements. The investigation will also evaluate safety of the Eversense 524 CGM System usage.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Continuous Glucose Monitoring Device Eversense 524 CGM System |
Device: Continuous Glucose Monitoring System
Eversense 524 CGM System
|
Outcome Measures
Primary Outcome Measures
- Effectiveness Objective: To determine accuracy of the Eversense 524 CGM System. [180 days]
The effectiveness measure will be mean absolute relative difference (MARD) for paired sensor and reference measurements through 180 days post-insertion for reference glucose values from 40-400 mg/dL. Effectiveness measures will be evaluated descriptively.
- Safety Objective: To demonstrate safety of the Eversense 524 CGM System [180days]
Incidence of device-related or sensor insertion/removal procedure-related serious adverse events
Eligibility Criteria
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
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Clinically confirmed diagnosis of diabetes mellitus for greater than or equal to 1 year.
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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:
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History of unexplained severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure
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History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
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Subjects with gastroparesis
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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
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A condition preventing or complicating the placement, operation or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition
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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.
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Hematocrit less than 38% or greater than 60% at screening
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History of hepatitis B, hepatitis C, or HIV
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Current treatment for a seizure disorder unless written clearance by neurologist to participate in study
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History of adrenal insufficiency
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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)
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Known topical or local anesthetic allergy
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Known allergy to glucocorticoids
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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
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Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during the study period
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The presence of any other active implanted device
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AMCR Institute Inc. | Escondido | California | United States | 92025 |
| 2 | Clinical Trials of Texas, LLC. (CTT) | San Antonio | Texas | United States | 78229 |
| 3 | Rainier Clinical Research Center | Renton | Washington | United States | 98057 |
Sponsors and Collaborators
- Senseonics, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CTP-0041