System Accuracy of BGM GL22

Diabetes Clinical Trial

Official title:

Evaluierung Der Systemgenauigkeit Des Blutglucosemonitoring Systems GL22 gemäß DIN EN ISO 15197:2015.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06146933
• Other study ID #: 2023_004
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diabetes

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