System Accuracy of the Blood Glucose Monitor for Personal Use Contour Care

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Diagnostic Test: blood glucose measuremen subject; Diagnostic Test: blood glucose measuremen reference

• Registration Number: NCT06037551
• Lead Sponsor: Institut fur Diabetes Karlsburg GmbH

Brief Summary

This study assesses the system accuracy of a blood glucose monitoring system in accordance with DIN EN ISO 15197:2015

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-07
• Study First Submitted QC: 2023-09-07
• Study First Posted: 2023-09-14
• Study Start: 2023-10-01
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subject glucometer measurement	blood glucose measuremen subject	Blood glucose measurement BGM for personal use
Subject glucometer measurement	blood glucose measuremen reference	Blood glucose measurement BGM for personal use

Primary Outcome Measures

Name	Time	Method
Analysis of system accuracy based on DIN EN ISO 15197	1 Day	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