NCT01871831

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

January 14, 2015

Status Verified

October 1, 2013

Enrollment Period

4 months

First QC Date

May 29, 2013

Last Update Submit

January 13, 2015

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

6 blood glucose monitoring systems for self-testingDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • male or female subjects with type 1 or type 2 diabetes or healthy subjects
  • signed informed consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ulm, 89081, Germany

Location

Related 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. doi: 10.1177/193229681300700611.

    PMID: 24351177RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Self-Testing

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Self CareTherapeutics

Study Officials

  • Cornelia Haug, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 7, 2013

Study Start

June 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

January 14, 2015

Record last verified: 2013-10

Locations

DE(1)