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NCT06037538 Clinical Trial

User Evaluation of BGM JS200B

Diabetes Clinical Trial

Official title:
Evaluierung Des Blutglukose Monitoring Systems JS200B Der Firma TysonBio gemäß DIN EN ISO 15197:2015

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06037538
Other study ID # 2023_003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 19, 2023
Est. completion date May 23, 2023

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

Performance Evaluation by the User of the Blood Glucose Monitoring System JS200B in accordance with DIN EN ISO 15197:2015

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date May 23, 2023
Est. primary completion date May 10, 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:
• blood glucose measurement by subject
blood glucose measurement by subject using finger tip capillary blood
• blood glucose measurement with reference
blood glucose measurement with reference method using finger tip capillary blood

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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