System Accuracy of the Blood Glucose Monitor for Personal Use JT100

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: NCT05124834
• Lead Sponsor: Institut fur Diabetes Karlsburg GmbH

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-11-08
• Study First Posted: 2021-11-18
• Study Start: 2022-01-15
• Status Verified: 2022-02
• Primary Completion: 2022-02-04
• Study Completion: 2022-02-04
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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, laboratory reference device	Blood glucose measurement BGM for personal use
Subject glucometer measurement	blood glucose measurement, blood glucose monitor for personal use	Blood glucose measurement BGM for personal use

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

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