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This is a single center, single arm non-randomized study of 48-hour CGMIS wear duration incorporating two meal-challenge tests to explore the performance of a single insertion combined glucose-sensing insulin delivery cannula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | All subjects using the study device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGMIS (Continuous Glucose Monitoring Infusion Set) | Device | An integrated combination CGM/insulin infusion system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy | Sensor accuracy as determined by mean absolute difference (MAD) for reference YSI venous blood glucose values ≤75 mg/dL and mean absolute relative difference (MARD) for reference YSI venous blood glucose values >75 mg/dL | First 48 hours |
| Accuracy | • Sensor accuracy in the performance metrics described in the FDA iCGM Special Controls. | First 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects who discontinue delivery of insulin through the device due to unexplained hyperglycemia | this will be the number of subjects who experience unexplained glycemic excursions requiring a cannula change | First 48 hours |
| Results of tolerability questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bob Janowski | Contact | 818-395-6576 | bjanowski@pacificdt.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rainier Clinical Research Center | Recruiting | Renton | Washington | 98057 | United States |
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A tolerability questionnaire will assess level of discomfort (none to severe), and duration. |
| First 48 hours |
| Results of Draize scale | Draize scale will be used by study staff to evaluate the presence and severity of erythema and edema at the site of device use after removal. | Firts 48 hours |
| Visual Analog Scale (VAS) for site discomfort | Subject will place a mark along a 100mm line to denote visually their perceived intensity of discomfort. Results will range from no discomfort to worst possible discomfort. | First 48 hours |