System Accuracy of the Blood Glucose Monitor for Personal Use JT100
Study Details
Study Description
Brief Summary
This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
This study assesses the system accuracy the blood glucose monitoring systems for personal use TJ100 pursuant to ISO 15197:2015 guidelines
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Subject glucometer measurement Blood glucose measurement BGM for personal use |
Diagnostic Test: blood glucose measurement, blood glucose monitor for personal use
measurement of the blood glucose concentration using the blood glucose monitor for personal use (TJ100)
Other Names:
Diagnostic Test: blood glucose measurement, laboratory reference device
measurement of the blood glucose concentration using a laboratory reference device (YSI 2300 Stat Plus)
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Outcome Measures
Primary Outcome Measures
- Analysis of system accuracy based on DIN EN ISO 15197 [day 1]
Assessment of the analytical measurement performance of the blood glucose monitor based on procedures defined in DIN EN ISO 15197
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female patients with clinical indication for blood glucose testing
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Signed form of consent
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Minimum age of 18 years
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Subjects are legally competent and capable to understand character, meaning and consequences of the study
Exclusion Criteria:
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Pregnancy or lactation
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Severe acute disease (at study physician's discretion)
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Acute or chronic diseases with inherent risk of aggravation by the procedure (at study physician's discretion)
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Current constitution that does not allow participating in the study (e.g. hematocrit out of
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the devices's specifications, medication known to influence blood glucose measurements; Appendix A of ISO 15197)
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Being unable to give informed consent
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Age younger than 18 years
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Legally incompetent
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Institut für Diabetes Karlsburg GmbH | Karlsburg | Mecklenburg Vorpommern | Germany | 17495 |
Sponsors and Collaborators
- Institut fur Diabetes Karlsburg GmbH
- Tyson Bioresearch Inc., Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan
Investigators
- Study Director: Eckhard Salzsieder, PhD, Institut fur Diabetes Karlsburg GmbH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IDK_ISO_2021_004