Performance Evaluation by the User of BGM Contour Care According to ISO 15197:2015

NCT06937736 | Completed

• 1 other identifier: 2024_002
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

Performance Evaluation by the User of the Blood Glucose Monitoring SystemContour Care in accordance with DIN EN ISO 15197:2015

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Analysis of system accuracy based on DIN EN ISO 15197

  Assessment of the analytical measurement performance of the blood glucose monitor

  Day 1

Study Arms (1)

Subject glucometer measurement

EXPERIMENTAL

Blood glucose measurement BGM for personal use

Diagnostic Test: blood glucose measurement by subject

Interventions

blood glucose measurement by subject DIAGNOSTIC_TEST

blood glucose measurement by subject using finger tip capillary blood

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 clinical indication for blood glucose measurements (i.e. Diabetes mellitus)
• Male or female patients with hypo-, eu- or hyperglycemia
• 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 that
• pose a risk of aggravation by the measure
• pose a health hazard to the personnel
• 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: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 22, 2025
• Study Start: June 20, 2024
• Primary Completion: July 16, 2024
• Study Completion: July 23, 2024
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)