System Accuracy of the Blood Glucose Monitor for Personal Use JT100

Sponsor
Institut fur Diabetes Karlsburg GmbH (Other)
Overall Status
Completed
CT.gov ID
NCT05124834
Collaborator
Tyson Bioresearch Inc., Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan (Other)
114
1
1
20
173.5

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
  • Diagnostic Test: blood glucose measurement, blood glucose monitor for personal use
  • Diagnostic Test: blood glucose measurement, laboratory reference device
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

Study Type:
Interventional
Actual Enrollment :
114 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluierung Der Systemgenauigkeit Des JT100 Blood Glucose Monitoring Systems Der Firma Tyson Bioresearch Inc. gemäß DIN EN ISO 15197:2015
Actual Study Start Date :
Jan 15, 2022
Actual Primary Completion Date :
Feb 4, 2022
Actual Study Completion Date :
Feb 4, 2022

Arms and Interventions

Arm Intervention/Treatment
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:
  • measurement of the blood glucose concentration using the blood glucose monitor for personal use (TJ100)
  • Diagnostic Test: blood glucose measurement, laboratory reference device
    measurement of the blood glucose concentration using a laboratory reference device (YSI 2300 Stat Plus)

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    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.
    Responsible Party:
    Matthes Kenning, Dr. Eckhard Salzsieder, Director, Institut fur Diabetes Karlsburg GmbH
    ClinicalTrials.gov Identifier:
    NCT05124834
    Other Study ID Numbers:
    • IDK_ISO_2021_004
    First Posted:
    Nov 18, 2021
    Last Update Posted:
    Feb 9, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Feb 9, 2022