DiabetesIDT-1326-IUNCT01871831
Assessment of Blood Glucose Monitoring Systems - Evaluation of Oxygen Dependency
A study testing 6 blood glucose monitoring systems for self-testing in people with Diabetes, run by Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- 6 blood glucose monitoring systems for self-testing
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2013to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- male or female subjects with type 1 or type 2 diabetes or healthy subjects
- signed informed consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft an der Universität Ulm
Ulm, 89081
About this study
Official title: Prüfung Von Blutzuckermesssystemen - Bewertung Der Sauerstoffabhängigkeit
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.
- Conditions
- Diabetes
- Being tested
- 6 blood glucose monitoring systems for self-testing
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 blood glucose monitoring systems for self-testingDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of the blood sample's partial pressure on blood glucose measurement results
Measured: For each sample, preparation and measurment procedure have an expected duration of about 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Sponsor
- Investigators
- Cornelia Haug, MD, Principal investigator, Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft an der Universität Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871831
- Sponsor's protocol ID
- IDT-1326-IU
- Acronym
- IDT-1326-IU
- Status last verified
- Oct 2013
- First submitted
- 29 May 2013
- Last updated
- 14 Jan 2015
- Results posted
- No
Publications
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.
PubMed 24351177
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prüfung Von Blutzuckermesssystemen - Bewertung Der Sauerstoffabhängigkeit
- ClinicalTrials.gov ID
- NCT01871831
- Acronym / sponsor ID
- IDT-1326-IU / IDT-1326-IU
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität UlmUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- Jun 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- male or female subjects with type 1 or type 2 diabetes or healthy subjects
- signed informed consent form
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6 blood glucose monitoring systems for self-testing | Device | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
- Results publication: PubMed 24351177Baumstark 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cornelia Haug, MD principal investigator
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft an der Universität Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 blood glucose monitoring systems for self-testing in people with Diabetes, run by Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01871831, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2015.