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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) and ROME CGM System with next generation feature enhancements compared to reference glucose measurements in adults 18 years of age and older with diabetes. The investigation will also evaluate safety of the Eversense 524 CGM System and ROME CGM System usage. Additionally, the safety and accuracy of the Eversense 524 CGM System will be evaluated in the pediatric population ages 14-17 with Type 1 Diabetes Mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Glucose Monitoring Device | Experimental | Eversense 524 CGM System and ROME CGM System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitoring System | Device | Eversense 524 CGM System and ROME CGM System. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness Objective: To determine accuracy of the Eversense 524 CGM System and ROME CGM System. | The effectiveness measure will be mean absolute relative difference (MARD) for paired sensor and reference measurements through 365 days post-insertion for reference glucose values from 40-400 mg/dL. Effectiveness measures will be evaluated descriptively. | 365 days |
| Safety Objective: To demonstrate safety of the Eversense 524 CGM System and ROME CGM System. | Incidence of device-related or sensor insertion/removal procedure-related serious adverse events | 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 | |
| Katherine Tweden | Contact | 240-624-2602 | katherine.tweden@senseonics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institute Inc. | Recruiting | Escondido | California | 92025 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39869118 | Derived | Bailey TS, Liljenquist DR, Denham DS, Brazg RL, Ioacara S, Masciotti J, Ghosh-Dastidar S, Tweden KS, Kaufman FR. Evaluation of Accuracy and Safety of the 365-Day Implantable Eversense Continuous Glucose Monitoring System: The ENHANCE Study. Diabetes Technol Ther. 2025 May;27(5):407-411. doi: 10.1089/dia.2024.0592. Epub 2025 Jan 27. |
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| Rocky Mountain Diabetes Center, LLC. (RMDC) | Recruiting | Idaho Falls | Idaho | 83404 | United States |
|
| Clinical Trials of Texas, LLC. (CTT) | Recruiting | San Antonio | Texas | 78229 | United States |
|
| Rainier Clinical Research Center | Recruiting | Renton | Washington | 98057 | United States |
|
| 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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