Assessment of Blood Glucose Monitoring Systems - Evaluation of Oxygen Dependency

Prüfung Von Blutzuckermesssystemen - Bewertung Der Sauerstoffabhängigkeit

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01871831

Acronym

IDT-1326-IU

Enrollment

Registered

2013-06-07

Start date

2013-06-30

Completion date

2013-10-31

Last updated

2015-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

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.

Interventions

DEVICE6 blood glucose monitoring systems for self-testing

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026