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To demonstrate point accuracy of the Abbott Sensor Based Glucose Monitoring System (System) interstitial glucose results against venous glucose reference and capillary fingerstick using the Consensus Error Grid over the wear duration. During the course of the wear duration, the subject is required to be testing fingerstick glucose measurement at least 8 times a day for capillary reference glucose measurements and three in-clinic visits of maximum 10 hours each for venous reference glucose measurements. With every reference measurement, the subject or study staff will perform a measurement on the System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No treatment | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System compared to venous and capillary glucose | To demonstrate point accuracy of the Abbott Sensor Based Glucose Monitoring (GM) System interstitial glucose results against venous glucose reference (YSI) using the Consensus Error Grid. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
Subject is pregnant, attempting to conceive or not willing and able to practice birth control during the study duration.
Subject has skin lesions, scarring, redness, infection or edema at the application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.
Subject currently is participating in another clinical trial.
Subject has donated blood within 112 days prior to the beginning of the study activities.
Subject has concomitant medical condition which, in the opinion of the Investigator, could interfere with the study or present a risk to the safety or welfare of the Subject or study staff. Such conditions include but are not limited to:
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Subjects with type 1 or type 2 diabetes requiring multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII). No more than 10 subjects (5 per site) will have HbA1c > 8.5%, and no more than 10 subjects (5 per site) will have HbA1c < 7% based on the subject screening.
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| Name | Affiliation | Role |
|---|---|---|
| Mark Christiansen, M.D. | Diablo Clinical Research | Principal Investigator |
| Leslie Klaff, M.D. | Rainier Clinical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diablo Clinical Research | Walnut Creek | California | 94598 | United States | ||
| Rainier Clinical Research Center |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Rainier |
| Washington |
| 98057 |
| United States |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |