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A prospective, multicenter evaluation of performance and safety of the Eversense Gemini System with flash glucose measurement feature. The purpose of this clinical investigation is to evaluate the accuracy of the Gemini System with new technological flash glucose monitoring (FGM) feature enhancements compared to reference glucose measurements and the Eversense 365 CGM System. The investigation will also evaluate safety of the Gemini System usage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Glucose Monitoring Device | Experimental | Eversense 365 Continuous Glucose Monitoring System and Gemini Glucose Monitoring System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitoring System | Device | Eversense 365 Continuous Glucose Monitoring System and Gemini Glucose Monitoring System |
|
| Measure | Description | Time Frame |
|---|---|---|
| System agreement (15/15%, 20/20%, 30/30%, and 40/40%) for paired sensor FGM and reference measurements post-insertion for reference glucose values from 40-400 mg/dL. | Effectiveness Objective: To determine accuracy of the Eversense 365 Continuous Glucose Monitoring System and Gemini Glucose Monitoring System. The effectiveness measure will be system agreement (15/15%, 20/20%, 30/30%, and 40/40%) for paired sensor FGM and reference measurements post-insertion for reference glucose values from 40-400 mg/dL. Effectiveness measures will be evaluated descriptively and compared to the Eversense 365 CGM System. | 365 days |
| Number of device-related or sensor insertion/removal procedure-related serious adverse events | Safety Objective: To demonstrate safety of the Eversense 365 Continuous Glucose Monitoring System and Gemini Glucose Monitoring System. Incidence of device-related or sensor insertion/removal procedure-related serious adverse events in clinic and during home use from sensor insertion through removal and follow-up. | 365 days |
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Inclusion Criteria:
Subjects meeting all of the following inclusion criteria will be included in this study:
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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maggie Lewis | Contact | 667-218-3309 | maggie.lewis@senseonics.com | |
| Susan Huynh | Contact | 301-407-2923 | susan.huynh@senseonics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Headlands Research - AMCR Institute | Recruiting | Escondido | California | 92025 | United States |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
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