Assessment of Blood Glucose Monitoring Systems - Evaluation of Oxygen Dependency

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Ulm, 89081, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

6 blood glucose monitoring systems for self-testing

Device

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

Roche Diagnostics GmbH

Registry information

Official study title

Prüfung Von Blutzuckermesssystemen - Bewertung Der Sauerstoffabhängigkeit

Acronym: IDT-1326-IU

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Jun 7, 2013
Registry last updated: Jan 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed