System Accuracy of the Blood Glucose Monitor for Personal Use BG-709b
NCT ID: NCT05091736
Last Updated: 2021-12-03
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
120 participants
INTERVENTIONAL
2021-10-18
2021-11-26
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 (BG-709b)
blood glucose measurement, laboratory reference device
measurement of the blood glucose concentration using a laboratory reference device
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 (BG-709b)
blood glucose measurement, laboratory reference device
measurement of the blood glucose concentration using a laboratory reference device
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
99 Years
ALL
Yes
Sponsors
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Hangzhou Sejoy Electronics & Instrument Co., ltd. Joytech Healthcare Co., ltd., PRC
UNKNOWN
Institut fur Diabetes Karlsburg GmbH
OTHER
Responsible Party
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Matthes Kenning
Dr. Eckhard Salzsieder, Director
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_003
Identifier Type: -
Identifier Source: org_study_id