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Completed

NCT Number: NCT07353125

System Accuracy and Performance Evaluation by the User of BGM LS-9

This study assesses the system accuracy and performance evaluation by the user of a blood glucose monitoring system pursuant to ISO 15197

Completed

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut für Diabetes Karlsburg GmbH

Karlsburg, Mecklenburg-Vorpommern, 17495, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucometer Test

Diagnostic Test

blood glucose measurement using finger tip capillary blood using BGM and reference method

Primary outcomes

  1. Analysis of system accuracy based on DIN EN ISO 15197

    Time frame: Day 1

    Assessment of the analytical measurement performance of the blood glucose monitor in accordance with DIN EN ISO 15197, section 6.3

  2. Analysis of system accuracy based on DIN EN ISO 15197

    Time frame: Day 1

    Assessment of the analytical measurement performance of the blood glucose monitor in accordance with DIN EN ISO 15197, section 8

Sponsors and collaborators

Lead sponsor

Institut fur Diabetes Karlsburg GmbH

Other

Registry information

Official study title

Evaluation of the Blood Glucose Monitoring System LS-9 of Leison Biotech Co., Ltd. in Accordance With DIN EN ISO 15197:2015

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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