Hematocrit Effect on a Blood Glucose Monitor

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Diagnostic Test: blood glucose measurement, blood glucose monitor for personal use; Diagnostic Test: blood glucose measurement, laboratory reference device

• Registration Number: NCT05158478
• Lead Sponsor: Institut fur Diabetes Karlsburg GmbH

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-02
• Study First Posted: 2021-12-15
• Study Start: 2022-02-22
• Primary Completion: 2022-02-22
• Study Completion: 2022-03-14
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subject glucometer measurement	blood glucose measurement, blood glucose monitor for personal use	-
Subject glucometer measurement	blood glucose measurement, laboratory reference device	-

Primary Outcome Measures

Name	Time	Method
repeatability precision	day 1	Assessment of the analytical measurement performance of the blood glucose monitor based on procedures defined in DIN EN ISO 15197

Trial Locations

Locations (1)

Institut für Diabetes Karlsburg GmbH; 🇩🇪 Karlsburg, Mecklenburg Vorpommern, Germany