System Accuracy of BGM GL60

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Diagnostic Test: Glucometer Test

• Registration Number: NCT06037486
• 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 ofthe blood glucose monitoring systems for personal use GL60 as outlined in DIN EN ISO 15197:2015.

Study Timeline

• Study Start: 2022-10-17
• Primary Completion: 2022-11-03
• Study Completion: 2022-11-15
• Status Verified: 2023-09
• Study First Submitted: 2023-09-07
• Study First Submitted QC: 2023-09-13
• Last Update Submitted: 2023-09-13
• Study First Posted: 2023-09-14
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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	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