System Accuracy of BGM GL22

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06146933

Enrollment

113

Registered

2023-11-27

Start date

2023-11-01

Completion date

2023-11-24

Last updated

2023-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Brief summary

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

Interventions

DIAGNOSTIC_TESTGlucometer Test

blood glucose measurement using finger tip capillary blood using BGM

DIAGNOSTIC_TESTRefernce Measurement

blood glucose measurement using finger tip capillary blood using reference method

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026