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To assess a 15-day wear period of the Cascade Continuous Glucose Monitoring (CGM) System
To assess a 15-day wear period for the Cascade CGM. The study wear period includes four in-clinic days in which frequent blood draws and Yellow Springs Instrument (YSI) glucose measurements will be performed. Participants will be blinded to CGM glucose values during the study. A retrospective performance assessment will be conducted following the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Continuous Monitoring | Experimental | Intervention: Device: Cascade Continuous Glucose Monitoring System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cascade Continuous Glucose Monitor | Device | Continuous Glucose Monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Use | Validate the feasibility of a 15-day wear period of the Cascade CGM. The primary endpoint is an 80% sensor survival rate over a 15-day wear period, which includes four in-clinic days and eleven at-home days. | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Performance | Accuracy performance compared to YSI readings. The secondary endpoints are: to achieve <15% Mean Average Relative Difference (MARD) and <20mg/dL Mean Average Difference (MAD) compared to YSI readings during the four in-clinic days and to assess Blood Glucose Meter (BGM) fingerstick calibration success. | 15 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mihailo V. Rebec, PhD | Contact | 503-855-5377 | mrebec@agamatrix.com | |
| Ellen M Anderson, MPH | Contact | 503-855-5377 | eanderson@agamatrix.com |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 12, 2022 | |
| Reset | May 25, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 12, 2022 | May 25, 2023 |
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