Blood Glucose Monitoring Systems: Discounter Versus Brand

October 13, 2021 updated by: Institut fur Diabetes Karlsburg GmbH

Cheap Equals Bad? Comparative System Accuracy of POCT Blood Glucose Monitoring Systems Under the Aspect of Aspect of Pricing: Discounter Versus Brand

This study assesses the system accuracy of 5 blood glucose monitoring systems pursuant to ISO 15197 under the aspect of the system's prospected costs for the user.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, with clinical indication for blood glucose measurement
  • Signed informed consent form
  • Minimum age of 18 years
  • Subjects are legally competent and capable to understand character, meaning and consequences of the study.

Exclusion Criteria:

  • Pregnancy or lactation period
  • Severe acute disease (at the study physician's discretion)
  • Severe chronic disease with inherent risk of aggravation by the procedure (at the study physician's discretion)
  • Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
  • A current constitution that does not allow participating in the study (e.g. hematocrit out of BGM specifications, medication known to influence blood glucose measurements; see Appendix A of ISO 15197)
  • Being unable to give informed consent
  • < 18 years
  • Legally incompetent

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 POCT glucometer measurement
Blood glucose measurement POCT glucometer
Diagnostic test: blood glucose measurement: POCT
measurement of blood glucose concentration using 5 different POCT glucometer
Diagnostic test: blood glucose measurement: reference
measurement of blood glucose concentration using 2 different laboratory analyzer

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 5 blood glucose montoring systems based on procedures defined in DIN EN ISO 15197
day 1

Collaborators and Investigators

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

Sponsor

Institut fur Diabetes Karlsburg GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

September 3, 2021

Primary Completion (Actual)

October 6, 2021

Study Completion (Actual)

October 6, 2021

Study Registration Dates

First Submitted

August 19, 2021

First Submitted That Met QC Criteria

August 26, 2021

First Posted (Actual)

September 1, 2021

Study Record Updates

Last Update Posted (Actual)

October 14, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • IDK_ISO_2021_002

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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