System Accuracy of 14 Blood Glucose Monitoring Systems

Not Applicable

Completed

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

• Registration Number: NCT06037499
• Lead Sponsor: Institut fur Diabetes Karlsburg GmbH

Brief Summary

The system accuracy of 14 blood glucose monitoring systems is to be evaluated randomly in accordance with DIN EN ISO 15197:2015 over thr courese of 24 months

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-03
• Study First Submitted: 2023-09-07
• Study First Submitted QC: 2023-09-07
• Study First Posted: 2023-09-14
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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
Blood glucose measurement using BGMS	Day 1

Trial Locations

Locations (1)

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