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The purpose of this study is to evaluate safety and accuracy of the IVBG System (the "System") when used to track blood glucose in insulin treated subjects with diabetes mellitus in an in-clinic setting for up to 72 hours (per subject). Reference blood glucose measurements will be collected across the entire reportable range of the System (e.g., 40 400 mg/dL) with adequate sampling at the upper and lower ends of this range. IVBG System accuracy will primarily be assessed relative to ISO 15197 criteria (i.e., within ±15 mg/dL at YSI glucose levels < 75 mg/dL, and within ±20% at YSI glucose levels >75 mg/dL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVBG | Device | Venous blood glucose measurement every 7.5 minutes for 72-hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| IVBG System accuracy will primarily be assessed relative to ISO 15197 criteria (i.e., within ±15 mg/dL at YSI glucose levels < 75 mg/dL, and within ±20% at YSI glucose levels >75 mg/dL). | 72-hours |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals with insulin-requiring diabetes mellitus
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institute for Clinical Research | Chula Vista | California | 91911 | United States | ||
| Advanced Metabolic Care + Research |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006943 | Hyperglycemia |
| 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 |
| Diabetes and Glandular Disease Research Associates, Inc. | San Antonio | Texas | 78229 | United States |