Hematocrit Effect on a Blood Glucose Monitor

Evaluation of the Hematocrit Effect on the Blood Glucose Monitor for Personal Use JT100

This study assesses the repeatability precision of a blood glucose monitoring system pursuant to ISO 15197

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Diagnostic test: blood glucose measurement, blood glucose monitor for personal use; Diagnostic test: blood glucose measurement, laboratory reference device

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Mecklenburg Vorpommern
    • Karlsburg, Mecklenburg Vorpommern, Germany, 17495
      • Institut für Diabetes Karlsburg GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
repeatability precision	Assessment of the analytical measurement performance of the blood glucose monitor based on procedures defined in DIN EN ISO 15197	day 1

Collaborators and Investigators

• Sponsor: Institut fur Diabetes Karlsburg GmbH
• Collaborators: Tyson Bioresearch Inc., Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2022
• Primary Completion (Actual): February 22, 2022
• Study Completion (Actual): March 14, 2022

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IDK_ISO_2021_005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No