Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| OptiScan Biomedical Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to demonstrate the accuracy of the OptiScanner glucose measurement. The accuracy of the test device will be determined using plasma samples collected directly from Type 1 and Type 2 Diabetics using the OptiScanner. Blood samples will simultaneously be collected and measured on YSI 2300 STAT PLUS (YSI) made by YSI Incorporated. These results will be compared to the OptiScanner's glucose measurement.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glucose and insulin IV to alter blood glucose | Other |
| Measure | Description | Time Frame |
|---|---|---|
| demonstrate the accuracy of the OptiScanner in measuring blood glucose levels in otherwise healthy diabetic subjects when compared to blood glucose levels simultaneously measured on the YSI |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary objective of the study is to demonstrate a blood glucose measurement range of 60 to 500 mg/dL at the hematocrit levels referenced as normal |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung | Neuss | 41460 | Germany |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided