User Performance Evaluation of Contour® Next One, Accu-Chek® Aviva Connect, FreeStyle Freedom Lite, OneTouch® Verio and GlucoMen® Areo Blood Glucose Monitoring Systems Following ISO 15197:2013
NCT ID: NCT03033849
Last Updated: 2017-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
189 participants
INTERVENTIONAL
2017-01-31
2017-03-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Groups
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Blood glucose measurement
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.
Blood glucose monitoring system for self-testing Contour® Next One
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.
Blood glucose monitoring system for self-testing Accu-Chek® Aviva Connect
Blood glucose monitoring system for self-testing FreeStyle Freedom Lite
Blood glucose monitoring system for self-testing OneTouch® Verio
Blood glucose monitoring system for self-testing GlucoMen® areo
Interventions
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Blood glucose monitoring system for self-testing Contour® Next One
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.
Blood glucose monitoring system for self-testing Accu-Chek® Aviva Connect
Blood glucose monitoring system for self-testing FreeStyle Freedom Lite
Blood glucose monitoring system for self-testing OneTouch® Verio
Blood glucose monitoring system for self-testing GlucoMen® areo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed informed consent form
* Minimum age of 18 years
* Subjects are legally competent and capable to understand character, meaning and consequences of the study.
* If blood glucose values \< 80 mg/dl or \> 300 mg/dl shall be measured after short term alteration in insulin therapy:
* Male or female with type 1 diabetes and intensified insulin therapy or insulin pump therapy.
* Signature of subjects to document consent with these procedures on informed consent form.
Exclusion Criteria
* Severe acute disease (at the study physician's discretion)
* Severe chronic disease with potential risk during the test procedures (at the study physician's discretion)
* Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
* Being unable to give informed consent
* \< 18 years
* Legally incompetent
* Being committed to an institution (e.g. psychiatric clinic)
* Language barriers potentially compromising an adequate compliance with study procedures
* Dependent on investigator or sponsor
* If blood glucose values \< 80 mg/dl shall be measured after short term alteration in insulin therapy, subjects with type 1 diabetes, suffering from:
* Coronary heart disease
* Condition after myocardial infarction
* Condition after cerebral events
* Peripheral arterial occlusive disease
* Hypoglycemia unawareness
18 Years
ALL
Yes
Sponsors
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Ascensia Diabetes Care
INDUSTRY
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
OTHER
Responsible Party
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Locations
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Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, Baden-Wurttemberg, Germany
Countries
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References
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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.
Other Identifiers
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IDT-1608-AL
Identifier Type: -
Identifier Source: org_study_id
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