User Evaluation of BGM VGM77

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Diagnostic Test: subject; Diagnostic Test: reference

• Registration Number: NCT06037512
• Lead Sponsor: Institut fur Diabetes Karlsburg GmbH

Brief Summary

Performance Evaluation by the User of the Blood Glucose Monitoring System VGM77Compliant with DIN EN ISO 15197:2015

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-13
• Primary Completion: 2023-06-06
• Study Completion: 2023-06-15
• Status Verified: 2023-09
• Study First Submitted: 2023-09-07
• Study First Submitted QC: 2023-09-07
• Last Update Submitted: 2023-09-07
• Study First Posted: 2023-09-14
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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	reference	Blood glucose measurement BGM for personal use
Subject glucometer measurement	subject	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

Trial Locations

Locations (1)

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