System Accuracy of the Blood Glucose Monitor for Personal Use Contour Care

April 14, 2025 updated by: Institut fur Diabetes Karlsburg GmbH

Evaluierung Des Blutglukose Monitoring Systems Contour Care Der Firma Ascensia Diabetes Care Deutschland GmbH gemäß DIN EN ISO 15197:2015

This study assesses the system accuracy of a blood glucose monitoring system in accordance with DIN EN ISO 15197:2015

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

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: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subject glucometer measurement
Blood glucose measurement BGM for personal use
Diagnostic test: blood glucose measuremen subject
measurement of the blood glucose concentration of subject using BGM and capillary finger tip blood
Diagnostic test: blood glucose measuremen reference
measurement of the blood glucose concentration of subject using reference method and capillary finger tip blood
Experimental: glucometer measurement
evaluation of repeatability measurement precision
Diagnostic test: blood glucose measuremen reference
measurement of the blood glucose concentration of subject using reference method and capillary finger tip blood

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: 1 Day
Assessment of the analytical measurement performance of the blood glucose monitor based on procedures defined in DIN EN ISO 15197
1 Day

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: Kerstin Rebrin, 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)

October 1, 2023

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

September 7, 2023

First Submitted That Met QC Criteria

September 7, 2023

First Posted (Actual)

September 14, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2023_005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

optional: age, blood glucose levels and hematocrit of subjects

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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