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NCT05124834 Clinical Trial

System Accuracy of the Blood Glucose Monitor for Personal Use JT100

Diabetes Mellitus Clinical Trial

Official title:
Evaluierung Der Systemgenauigkeit Des JT100 Blood Glucose Monitoring Systems Der Firma Tyson Bioresearch Inc. gemäß DIN EN ISO 15197:2015

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05124834
Other study ID # IDK_ISO_2021_004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2022
Est. completion date February 4, 2022

Study information
Verified date February 2022
Source Institut fur Diabetes Karlsburg GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197

Description:

This study assesses the system accuracy the blood glucose monitoring systems for personal use TJ100 pursuant to ISO 15197:2015 guidelines

Recruitment information / eligibility
Status Completed
Enrollment 114
Est. completion date February 4, 2022
Est. primary completion date February 4, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female patients with clinical indication for blood glucose testing - 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: - Pregnancy or lactation - 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

Study Design

Related Conditions & MeSH terms

Intervention

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)
• blood glucose measurement, laboratory reference device
measurement of the blood glucose concentration using a laboratory reference device (YSI 2300 Stat Plus)

Locations
Country Name City State
Germany Institut für Diabetes Karlsburg GmbH Karlsburg Mecklenburg Vorpommern

Sponsors (2)
Lead Sponsor Collaborator
Institut fur Diabetes Karlsburg GmbH Tyson Bioresearch Inc., Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Analysis of system accuracy based on DIN EN ISO 15197 Assessment of the analytical measurement performance of the blood glucose monitor based on procedures defined in DIN EN ISO 15197 day 1
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