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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
In this clinical trial, accuracy evaluation of Bayer Contour XT blood glucose monitoring system and blood glucose monitoring systems from other companies across the overall tested glucose range will be performed.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4 blood glucose monitoring systems | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in accuracy between blood glucose monitoring systems across the overall tested glucose range by comparing the mean absolute value of relative (percent) difference (MARD) between the meter value and the reference value | For each subject, the experimental phase has an expected duration of up to 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm | Ulm | 89081 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25872967 | Result | Link M, Schmid C, Pleus S, Baumstark A, Rittmeyer D, Haug C, Freckmann G. System Accuracy Evaluation of Four Systems for Self-Monitoring of Blood Glucose Following ISO 15197 Using a Glucose Oxidase and a Hexokinase-Based Comparison Method. J Diabetes Sci Technol. 2015 Apr 14;9(5):1041-50. doi: 10.1177/1932296815580161. | |
| 26062008 | Result |
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| Freckmann G, Pleus S, Link M, Baumstark A, Schmid C, Hogel J, Haug C. Accuracy Evaluation of Four Blood Glucose Monitoring Systems in Unaltered Blood Samples in the Low Glycemic Range and Blood Samples in the Concentration Range Defined by ISO 15197. Diabetes Technol Ther. 2015 Sep;17(9):625-34. doi: 10.1089/dia.2015.0043. Epub 2015 May 19. |
| 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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