Assessment of Blood Glucose Monitoring Systems - Evaluation of Oxygen Dependency

Not Applicable

Completed

• Conditions: Diabetes

• Registration Number: NCT01871831
• Lead Sponsor: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-29
• Study Start: 2013-06
• Study First Submitted QC: 2013-06-04
• Study First Posted: 2013-06-07
• Status Verified: 2013-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2015-01-13
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft an der Universität Ulm; 🇩🇪 Ulm, Germany