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The device is no longer under development.
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The purpose of this study is to find out how well a new continuous glucose monitor works for people with diabetes. This study will test the performance of the study sensor(s) for 7-14 days of wear in patients who are 11-80 years old with type 1 or type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with diabetes wearing DS5 | Experimental | Subjects wearing DS5 over 7-14 days and participating in FSTs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitoring | Device | CGM and frequent sample testing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoints | Descriptive summary will be used to characterize: • Skin assessment of subject's glucose sensor insertion sites | The subject's participation from study enrollment to study exit is approximately 7 to 44 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| ProSciento |
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| Chula Vista |
| California |
| 91911 |
| United States |
| John Muir Health | Concord | California | 94520 | United States |
| Headlands Research California, LLC | Escondido | California | 92025 | United States |
| Sansum Diabetes Research Institute | Goleta | California | 93111 | United States |
| Rady Children's Hospital | San Diego | California | 92123 | United States |
| University of California San Francisco | San Francisco | California | 94158 | United States |
| Mills-Peninsula Medical Center: Diabetes Research Institute | San Mateo | California | 94401 | United States |
| Diablo Clinical Research | Walnut Creek | California | 94598 | United States |
| Barbara Davis Center for Childhood Diabetes | Aurora | Colorado | 80045 | United States |
| Barbara Davis Center for Diabetes | Aurora | Colorado | 80045 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Atlanta Diabetes | Atlanta | Georgia | 30318 | United States |
| Endocrine Research Solutions | Roswell | Georgia | 30076 | United States |
| Rocky Mountain Clinical Research | Idaho Falls | Idaho | 83404 | United States |
| Iowa Diabetes and Endocrinology Center | West Des Moines | Iowa | 50265 | United States |
| Barry J Reiner, MD, LLC | Baltimore | Maryland | 21229 | United States |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| Northwell Health | New Hyde Park | New York | 11042v | United States |
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27104 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| ClinRĂ© 001-007 | Bartlett | Tennessee | 38133 | United States |
| Texas Diabetes and Endocrinology | Austin | Texas | 78749 | United States |
| Tekton Research | McKinney | Texas | 75069 | United States |
| Texas Diabetes & Endocrinology | Round Rock | Texas | 78681 | United States |
| Diabetes & Glandular Disease Clinic | San Antonio | Texas | 78229 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22903 | United States |
| Rainier Clinical Research Center | Renton | Washington | 98057 | United States |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| 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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