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NCT06037499 Clinical Trial

System Accuracy of 14 Blood Glucose Monitoring Systems

Diabetes Clinical Trial

Official title:
Leistungsbewertungsprüfung Der Systemgenauigkeit, Von 14 Blutglukose Monitoring Systemen in Anlehnung an ISO 15197:2015

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06037499
Other study ID # 2023_001
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date March 3, 2023
Est. completion date March 1, 2025

Study information
Verified date September 2023
Source Institut fur Diabetes Karlsburg GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 500
Est. completion date March 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Male or female patients with hypo-, eu- or hyperglycaemia - The written informed consent had to be signed - The volunteers must be older than 18 years - The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved Exclusion criteria: - Pregnancy or lactation - Acute or chronic diseases with the risk of aggravation by the measure - A current constitution that does not allow participating in the study - Participation in another study or activity with the blood glucose measuring system evaluated in the present study - Application of substances listed in Appendix A of DIN EN ISO 15197:2015

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Glucometer Test
measurement of blood glucose concentration using different BGM and Reference Method

Locations
Country Name City State
Germany Institut für Diabetes Karlsburg GmbH Karlsburg Mecklenburg Vorpommern

Sponsors (1)
Lead Sponsor Collaborator
Institut fur Diabetes Karlsburg GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood glucose measurement using BGMS Day 1
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