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Hematocrit Effect on a Blood Glucose Monitor

Sponsor
Institut fur Diabetes Karlsburg GmbH (Other)
Overall Status
Completed
CT.gov ID
NCT05158478
Collaborator
Tyson Bioresearch Inc., Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan (Other)
1
Enrollment
1
Location
1
Arm
20
Actual Duration (Days)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of the Hematocrit Effect on the Blood Glucose Monitor for Personal Use JT100
Actual Study Start Date :
Feb 22, 2022
Actual Primary Completion Date :
Feb 22, 2022
Actual Study Completion Date :
Mar 14, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Subject glucometer measurement

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. repeatability precision [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, Director, PhD, Institut fur Diabetes Karlsburg GmbH
    ClinicalTrials.gov Identifier:
    NCT05158478
    Other Study ID Numbers:
    • IDK_ISO_2021_005
    First Posted:
    Dec 15, 2021
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jul 1, 2022
    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 Jul 28, 2022