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NCT06037486 Clinical Trial

System Accuracy of BGM GL60

Diabetes Mellitus Clinical Trial

Official title:
Evaluierung Der Systemgenauigkeit Des Blutglucosemonitoring Systems GL60 gemäß DIN EN ISO 15197:2015

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06037486
Other study ID # 2022_002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 17, 2022
Est. completion date November 15, 2022

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

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

Description:

This study assesses the system accuracy ofthe blood glucose monitoring systems for personal use GL60 as outlined in DIN EN ISO 15197:2015.

Recruitment information / eligibility
Status Completed
Enrollment 101
Est. completion date November 15, 2022
Est. primary completion date November 3, 2022
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 the blood glucose concentration using the blood glucose monitor for personal use

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

Sponsors (2)
Lead Sponsor Collaborator
Institut fur Diabetes Karlsburg GmbH Beurer GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Analysis of system accuracy based on DIN EN ISO 15197 Assessment of the analytical measurement performance of the blood glucose monitor Day 1
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