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

January 19, 2026 updated by: Matthes Kenning, Institut fur Diabetes Karlsburg GmbH

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

219

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Mecklenburg-Vorpommern
      • Karlsburg, Mecklenburg-Vorpommern, Germany, 17495
        • Institut für Diabetes Karlsburg GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subject glucometer measurement
Diagnostic test: Glucometer Test
blood glucose measurement using finger tip capillary blood using BGM and reference method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 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 8
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut fur Diabetes Karlsburg GmbH

Investigators

  • Study Director: Eckhard Salzsieder, PhD, Institut für Diabetes Karlsburg GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2025

Primary Completion (Actual)

September 16, 2025

Study Completion (Actual)

September 22, 2025

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025_004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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