Assessment of Blood Glucose Monitoring Systems - Evaluation of Oxygen Dependency

NCT ID: NCT01871831

Last Updated: 2015-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes

Interventions

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6 blood glucose monitoring systems for self-testing

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Roche Diagnostics GmbH

INDUSTRY

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cornelia Haug, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Ulm, , Germany

Site Status

Countries

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Germany

References

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Baumstark A, Schmid C, Pleus S, Haug C, Freckmann G. Influence of partial pressure of oxygen in blood samples on measurement performance in glucose-oxidase-based systems for self-monitoring of blood glucose. J Diabetes Sci Technol. 2013 Nov 1;7(6):1513-21. doi: 10.1177/193229681300700611.

Reference Type RESULT
PMID: 24351177 (View on PubMed)

Related Links

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Other Identifiers

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IDT-1326-IU

Identifier Type: -

Identifier Source: org_study_id

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