Blood Glucose Monitoring Systems: Discounter Versus Brand
NCT ID: NCT05031000
Last Updated: 2021-10-14
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
122 participants
INTERVENTIONAL
2021-09-03
2021-10-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Subject POCT glucometer measurement
Blood glucose measurement POCT glucometer
blood glucose measurement: POCT
measurement of blood glucose concentration using 5 different POCT glucometer
blood glucose measurement: reference
measurement of blood glucose concentration using 2 different laboratory analyzer
Interventions
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blood glucose measurement: POCT
measurement of blood glucose concentration using 5 different POCT glucometer
blood glucose measurement: reference
measurement of blood glucose concentration using 2 different laboratory analyzer
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.
Exclusion Criteria
* Severe acute disease (at the study physician's discretion)
* Severe chronic disease with inherent risk of aggravation by the procedure (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)
* A current constitution that does not allow participating in the study (e.g. hematocrit out of BGM specifications, medication known to influence blood glucose measurements; see Appendix A of ISO 15197)
* Being unable to give informed consent
* \< 18 years
* Legally incompetent
18 Years
ALL
Yes
Sponsors
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Institut fur Diabetes Karlsburg GmbH
OTHER
Responsible Party
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Principal Investigators
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Eckhard Salzsieder, PhD
Role: STUDY_DIRECTOR
Institut fur Diabetes Karlsburg GmbH
Locations
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Institut für Diabetes Karlsburg GmbH
Karlsburg, Mecklenburg-Vorpommern, Germany
Countries
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Related Links
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Blood sugar
ISO 15197
Other Identifiers
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IDK_ISO_2021_002
Identifier Type: -
Identifier Source: org_study_id