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

NCT07353125 | Completed

• 1 other identifier: 2025_004
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes

Keywords

System Accuracy; Performance Evaluation by the User; DIN EN ISO 15197

Outcome Measures

Primary Outcomes (2)

• Analysis of system accuracy based on DIN EN ISO 15197

  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

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

  Day 1

Study Arms (1)

Subject glucometer measurement

EXPERIMENTAL

Diagnostic Test: Glucometer Test

Interventions

Glucometer Test DIAGNOSTIC_TEST

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

Subject glucometer measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut fur Diabetes Karlsburg GmbH: lead

Study Sites (1)

Institut für Diabetes Karlsburg GmbH

Karlsburg, Mecklenburg-Vorpommern, 17495, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Eckhard Salzsieder, PhD

  Institut fur Diabetes Karlsburg GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Eckhard Salzsieder, Principal Investigator

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 20, 2026
• Study Start: July 21, 2025
• Primary Completion: September 16, 2025
• Study Completion: September 22, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)