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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06146933
Other study ID # 2023_004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date November 24, 2023

Study information

Verified date November 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 of a blood glucose monitoring system pursuant to ISO 15197


Recruitment information / eligibility

Status Completed
Enrollment 113
Est. completion date November 24, 2023
Est. primary completion date November 22, 2023
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
blood glucose measurement using finger tip capillary blood using BGM
Refernce Measurement
blood glucose measurement using finger tip capillary blood using 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 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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