System Accuracy of BGM GL22

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Diagnostic Test: Glucometer Test; Diagnostic Test: Refernce Measurement

• Registration Number: NCT06146933
• Lead Sponsor: Institut fur Diabetes Karlsburg GmbH

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-07
• Status Verified: 2023-11
• Study Start: 2023-11-01
• Primary Completion: 2023-11-22
• Study Completion: 2023-11-24
• Study First Submitted QC: 2023-11-24
• Last Update Submitted: 2023-11-24
• Study First Posted: 2023-11-27
• Last Update Posted: 2023-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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	Refernce Measurement	-
Subject glucometer measurement	Glucometer Test	-

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

Trial Locations

Locations (1)

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