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| Name | Class |
|---|---|
| Ascensia Diabetes Care | INDUSTRY |
The user performance evaluation shows whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system. In this study, user performance evaluation will be performed for Contour® Next One (Ascensia Diabetes Care GmbH), Accu-Chek® Aviva Connect (Roche Diabetes Care GmbH), FreeStyle Freedom Lite (Abbott Diabetes Care Inc.), OneTouch® Verio (LifeScan Europe) and GlucoMen® areo A. Menarini Diagnostics S.r.l. (based on ISO 15197:2013; EN ISO 15197:2015, clause 8.
For each BGMS, measurement procedures for user performance evaluation will be performed with 1 test meter and 1 reagent system lot by the study subjects.
The same meter and an additional test meter will be used for double measurements performed by study personnel (with the same reagent system lot used by subjects).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood glucose measurement | Experimental | Every study subject shall test three out of the five devices. The testing order of the BGMS will be changed on each subject to minimize any order effects on measurement results. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood glucose monitoring system for self-testing Contour® Next One | Device | This is a user performance study, that is intended to show whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system (BGMS). The subjects' measurement technique (e.g. applying blood onto the system reagent, reading the result) will be observed and documented by study personnel. Immediately after the measurement by the subject, the study personnel will perform a measurement with the same test meter. Measurement results obtained by the subjects with the BGMS will be compared to measurement results obtained with the comparison method. Sample collection for the comparison measurement will be performed by study personnel within 5 min after the subject's measurement with the test meter. The samples will be collected from the subjects' skin puncture (if possible), an additional skin puncture (if required) will be documented. An additional skin puncture will be performed by study personnel with single-use lancing devices. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptance criteria defined by ISO 15197:2013 (E) will be applied | 95 % of the individual glucose measured values shall fall within ± 15 mg/dl (0.83 mmol/l) of the measured values of the comparison measurement procedure at glucose concentrations < 100 mg/dl (5.55 mmol/l) and within ± 15 % at glucose concentrations ≥ 100 mg/dl (5.55 mmol/l). | For each subject, the experimental phase has an expected duration of up to 3 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 | Baden-Wurttemberg | 89081 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29927663 | Derived | Jendrike N, Baumstark A, Pleus S, Liebing C, Kamecke U, Haug C, Freckmann G. Accuracy of five systems for self-monitoring of blood glucose in the hands of adult lay-users and professionals applying ISO 15197:2013 accuracy criteria and potential insulin dosing errors. Curr Med Res Opin. 2019 Feb;35(2):301-311. doi: 10.1080/03007995.2018.1491832. Epub 2018 Jul 19. |
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| Blood glucose monitoring system for self-testing Accu-Chek® Aviva Connect | Device |
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| Blood glucose monitoring system for self-testing FreeStyle Freedom Lite | Device |
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| Blood glucose monitoring system for self-testing OneTouch® Verio | Device |
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| Blood glucose monitoring system for self-testing GlucoMen® areo | Device |
|
| 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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