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The purpose of this study is to evaluate the safety and effectiveness of the next-generation DexCom SEVEN Continuous Glucose Monitoring System (SEVEN.2 System) when worn for up to 7-days by subjects >18 years-old with diabetes mellitus requiring insulin therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Adult subjects (at least 18 years of age) with a diagnosis of type 1 diabetes (~80%) or insulin-treated type 2 diabetes (~20%); method of insulin delivery may be multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) |
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| Measure | Description | Time Frame |
|---|---|---|
| SEVEN.2 System accuracy as compared to Yellow Springs Instrument (YSI) venous blood glucose measurements | Days 1, 4, and 7 of Sensor wear |
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Inclusion Criteria:
Exclusion Criteria:
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Ambulatory (non-hospitalized) individuals with type 1 diabetes or insulin-treated type 2 diabetes selected from endocrinology clinics within the United States
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| Name | Affiliation | Role |
|---|---|---|
| Andrew K Balo, BS | DexCom, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Muir Physician Network Clinical Research Center | Concord | California | 94520 | United States | ||
| Advanced Metabolic Care + Research |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| 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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| Escondido |
| California |
| 92026 |
| United States |
| Sansum Diabetes Research Institute | Santa Barbara | California | 93105 | United States |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |