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
1 participants
INTERVENTIONAL
2022-02-22
2022-03-14
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 glucometer measurement
blood glucose measurement, blood glucose monitor for personal use
measurement of the blood glucose concentration using the blood glucose monitor for personal use (TJ100)
blood glucose measurement, laboratory reference device
measurement of the blood glucose concentration using a laboratory reference device (YSI 2300 Stat Plus)
Interventions
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blood glucose measurement, blood glucose monitor for personal use
measurement of the blood glucose concentration using the blood glucose monitor for personal use (TJ100)
blood glucose measurement, laboratory reference device
measurement of the blood glucose concentration using a laboratory reference device (YSI 2300 Stat Plus)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed form of consent
* 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 study physician's discretion)
* Acute or chronic diseases with inherent risk of aggravation by the procedure (at study physician's discretion)
* Current constitution that does not allow participating in the study (e.g. hematocrit out of
* the devices's specifications, medication known to influence blood glucose measurements; Appendix A of ISO 15197)
* Being unable to give informed consent
* Age younger than 18 years
* Legally incompetent
18 Years
ALL
Yes
Sponsors
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Tyson Bioresearch Inc., Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan
UNKNOWN
Institut fur Diabetes Karlsburg GmbH
OTHER
Responsible Party
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Matthes Kenning
Director, PhD
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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Other Identifiers
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IDK_ISO_2021_005
Identifier Type: -
Identifier Source: org_study_id
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