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The purpose of this clinical investigation is to evaluate the accuracy of the Eversense Continuous Glucose Monitoring System (Eversense System) measurements when compared with a Self-monitoring blood glucose (SMBG) meter. The investigation will assess device performance in two insertion locations (abdomen and upper arm), evaluate safety of the Eversense System usage, and assess the usability of the Eversense system in the hands of user at home setting. Changes in HbA1c from baseline will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eversense (Senseonics) CGM System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eversense (Senseonics) Continuous Glucose Monitoring System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Eversense CGM System for Arm and Abdomen Sensors compared to SMBG Meter as determined by Mean Absolute Relative Difference (MARD) calculations. | 180 Days | |
| Usability of the Eversense CGM System over 180 days will be evaluated through Study Questionnaires. | 180 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mona Landin-Olsson, M.D., Ph.D | Skane University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetic Center, Sahlgrenska University Hospital | Gothenburg | 41345 | Sweden | |||
| Skåne University Hospital |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine 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 |
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| Lund |
| 22185 |
| Sweden |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |