Assessment of Blood Glucose Monitoring Systems - Evaluation of Oxygen Dependency (IDT-1326-IU)

January 13, 2015 updated by: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

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Systems for blood glucose monitoring with glucose oxidase enzyme reaction on test strips can be affected by the partial pressure of oxygen of the blood sample. In this study, we investigate the influence of different partial pressure of oxygen in blood samples on measurement results. Systems with labelled oxygen-dependency as well as systems without labelled oxygen-dependency are evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

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
      • Ulm, Germany, 89081
        • Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft an der Universität Ulm

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:

  • 18 years of age or older
  • male or female subjects with type 1 or type 2 diabetes or healthy subjects
  • signed informed consent form

Exclusion Criteria:

  • pregnancy or lactation period
  • severe acute illness that, in the opinion of the investigator, might pose additional risk to the subject
  • severe chronic illness that, in the opinion of the investigator, might pose additional risk to the subject

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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Influence of the blood sample's partial pressure on blood glucose measurement results
Time Frame: For each sample, preparation and measurment procedure have an expected duration of about 2 hours
For each sample, preparation and measurment procedure have an expected duration of about 2 hours

Collaborators and Investigators

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

Sponsor

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Collaborators

Roche Diagnostics

Investigators

  • Principal Investigator: Cornelia Haug, MD, Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft an der Universität Ulm

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.

General Publications

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

June 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

June 4, 2013

First Posted (Estimate)

June 7, 2013

Study Record Updates

Last Update Posted (Estimate)

January 14, 2015

Last Update Submitted That Met QC Criteria

January 13, 2015

Last Verified

October 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • IDT-1326-IU

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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