Assessment of Blood Glucose Monitoring Systems - Evaluation of Oxygen Dependency

Diabetes Clinical Trial

— IDT-1326-IU  

Official title:

Prüfung Von Blutzuckermesssystemen - Bewertung Der Sauerstoffabhängigkeit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01871831
• Other study ID #: IDT-1326-IU
• Status: Completed
• Phase: N/A
• First received: May 29, 2013
• Last updated: January 13, 2015
• Start date: June 2013
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• 6 blood glucose monitoring systems for self-testing

Locations

Country	Name	City	State
Germany	Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft an der Universität Ulm	Ulm

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm	Roche Diagnostics GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influence of the blood sample`s partial pressure on blood glucose measurement results		For each sample, preparation and measurment procedure have an expected duration of about 2 hours

External Links

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