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| Name | Class |
|---|---|
| Cnoga Medical Ltd. | INDUSTRY |
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Open label, prospective, comparative, multi-center study. All participants will get an introduction to the invasive component of the TENSORTIP COG by means of the instructions for use in English language only (incl. an illustrated short manual) and will be asked to perform a reading without further device training. Thereafter, a healthcare professional will perform an additional reading with the reference method (YSI 2300 STAT plus). In addition, blood will be drawn for determination of hematocrit. In the study, a minimum of 10 test strip vials that cover a minimum of 3 strip lots will be used. In addition multiple devices will be employed. After completion of the study the study participants will be given a questionnaire to fill out.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood glucose measurement | Other | After the patient has performed the manual reading, the investigator or staff member will obtain another capillary blood sample and a reference reading by means of the YSI 2300 Stat plus analyzer will be performed and recorded. If patients need more than one attempt to get a successful blood glucose reading, the number of attempts will be documented. A questionnaire needs to filled by the participant |
| Measure | Description | Time Frame |
|---|---|---|
| measurement performance | invasive CoG (study device) blood glucose measurement in comparison to blood glucose measurment of a comparator device (YSI 2300 STAT Plus). | up to 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rainier Clinical Research Center, Inc. | Renton | Washington | 98057 | United States |
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| ID | Term |
|---|---|
| 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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| ID | Term |
|---|---|
| D001786 | Blood Glucose |
| ID | Term |
|---|---|
| D005947 | Glucose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 |
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| Carbohydrates |