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

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

Status: Completed

Conditions: Diabetes

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01871831

IDT-1326-IU

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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