Blood GlucoseNCT00906490
Clinical Study of the Intravenous Blood Glucose System in Hospitalized Adult Elective or Non-Emergent Surgery and Medical/Surgical Intensive Care Unit Patients
An observational study of Blood Glucose, run by Edwards Lifesciences at 5 sites in United States.
Trial summary
The primary objective of this study is to evaluate the performance and safety of the intravenous blood glucose (IVBG) System relative to point of care (POC) meter performance when each method is compared to the Yellow Springs Instrument (YSI) under various conditions in the operating room (OR), ICU and general ward… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Glucose
- What is being tested?
- Intravenous Blood Glucose monitoring system
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2009to May 2010
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Acute care facility patient with a minimum of 24 hour ICU stay.
Who may be able to join
- ICU ≥ 24 hours
- sign ICF
Who cannot join
- transplant Pt
- brain injury/surgery
- DKA
- end stage disease
- restricted venous access
- hx of HITT
Show all 9Show fewer
- contraindication for anti-coagulation Tx
- positive pregnancy test
- in other drug, device, or biologic study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Maryland School of Medicine
Baltimore, Maryland, 21201
International Diabetes Center (IDC), Methodist Hospital
Minneapolis, Minnesota, 55416
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Providence Heart and Vascular Institute
Portland, Oregon, 97225
Washington Hospital Center (WHC)
Washington D.C., District of Columbia, 20010
About this study
Official title: Observational Clinical Study of the Intravenous Blood Glucose System in Hospitalized Adult Elective or Non-Emergent Surgery and Medical/Surgical Intensive Care Unit Patients
The primary objective of this study is to evaluate the performance and safety of the intravenous blood glucose (IVBG) System relative to point of care (POC) meter performance when each method is compared to the Yellow Springs Instrument (YSI) under various conditions in the operating room (OR), ICU and general ward (GW) in subjects undergoing elective or non-emergent surgery as well as subjects admitted to the medical/surgical ICU. POC meter systems are currently used in the hospital environment to measure blood glucose values. The YSI is an accepted reference standard for assessing POC meter accuracy.
The secondary objective of this study is to evaluate the performance of the IVBG System as compared with the YSI under various conditions in the operating room (OR), intensive care unit (ICU) and general ward (GW) in subjects undergoing elective or non-emergent surgery as well as subjects admitted to the medical/surgical ICU.
Read the detailed description
Subjects will have their glucose values collected from the IVBG System and compared with paired plasma glucose measurements obtained using theYSI with comparative blood samples collected from a CVC, an arterial line or a peripheral vein.
- Blood samples collected per time point: approximately 2ml for waste and1mL for glucose measurement. In the event that a closed blood drawing system is utilized, the waste would be reduced or eliminated.
- The comparative blood samples will be drawn manually at a maximum frequency of once every four hours.
- Sample draws not to exceed 23 per subject for the duration of the study. This includes 18 comparative blood samples and 5 calibration samples to be draw as needed (e.g. recalibration). Including the partial thromboplastin time (PTT) draws described in section 3.1.2, there would be approximately 100 mL or 6.8 tablespoons drawn per subject. In the case where a closed blood drawing system is used consistently, this would be approximately 50 mL or 3.4 tablespoons per subject.
POC meter blood glucose measurements will be performed at the same time as the blood sample draws described above.
- Conditions
- Blood Glucose
- Being tested
- Intravenous Blood Glucose monitoring system
- Keywords
- Glucose Monitoring, Accurate Blood Glucose Monitoring in critical care setting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Blood Glucose monitoring systemDevice
Insertion of blood glucose monitoring sensor into peripheral vascular IV line.
What is being measured
The primary outcome is the main question the study is designed to answer.
A non-inferior design to demonstrate that the IVBG System is equivalent (non-inferior) to a POC meter with respect to the proportion of glucose measurements that are deemed acceptable using a metric defined in ISO 15197.
Measured: During 72 hours of anticipated Sensor dwell time
Secondary outcomes (1)
Accuracy of Device against YSI (Blood Glucose Analyser)
Measured: During 72 hours of anticipated Sensor dwell time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood GlucoseStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DexCom, Inc., Medical Device Consultants, Inc.
- Responsible party
- Sponsor
- Investigators
- Grand Bochicchio, MD, Principal investigator, University of Maryland Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906490
- Sponsor's protocol ID
- 2008-11
- Status last verified
- Aug 2013
- First submitted
- 20 May 2009
- Last updated
- 20 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Clinical Study of the Intravenous Blood Glucose System in Hospitalized Adult Elective or Non-Emergent Surgery and Medical/Surgical Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT00906490
- Acronym / sponsor ID
- 2008-11
- Conditions
- Blood Glucose
- Keywords
- Glucose Monitoring, Accurate Blood Glucose Monitoring in critical care setting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Collaborators
- DexCom, Inc., Medical Device Consultants, Inc.
- Study start
- Jun 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 21 May 2009 (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.
The primary objective of this study is to evaluate the performance and safety of the intravenous blood glucose (IVBG) System relative to point of care (POC) meter performance when each method is compared to the Yellow Springs Instrument (YSI) under various conditions in the operating room (OR), ICU and general ward (GW) in subjects undergoing elective or non-emergent surgery as well as subjects admitted to the medical/surgical ICU. POC meter systems are currently used in the hospital environment to measure blood glucose values. The YSI is an accepted reference standard for assessing POC meter accuracy.
The secondary objective of this study is to evaluate the performance of the IVBG System as compared with the YSI under various conditions in the operating room (OR), intensive care unit (ICU) and general ward (GW) in subjects undergoing elective or non-emergent surgery as well as subjects admitted to the medical/surgical ICU.
Detailed description
Subjects will have their glucose values collected from the IVBG System and compared with paired plasma glucose measurements obtained using theYSI with comparative blood samples collected from a CVC, an arterial line or a peripheral vein.
- Blood samples collected per time point: approximately 2ml for waste and1mL for glucose measurement. In the event that a closed blood drawing system is utilized, the waste would be reduced or eliminated.
- The comparative blood samples will be drawn manually at a maximum frequency of once every four hours.
- Sample draws not to exceed 23 per subject for the duration of the study. This includes 18 comparative blood samples and 5 calibration samples to be draw as needed (e.g. recalibration). Including the partial thromboplastin time (PTT) draws described in section 3.1.2, there would be approximately 100 mL or 6.8 tablespoons drawn per subject. In the case where a closed blood drawing system is used consistently, this would be approximately 50 mL or 3.4 tablespoons per subject.
POC meter blood glucose measurements will be performed at the same time as the blood sample draws described above.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute care facility patient with a minimum of 24 hour ICU stay.
Key inclusion criteria (2 listed)
- ICU ≥ 24 hours
- sign ICF
Key exclusion criteria (9 listed)
- transplant Pt
- brain injury/surgery
- DKA
- end stage disease
- restricted venous access
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 |
|---|---|---|
| Intravenous Blood Glucose monitoring systemInsertion of blood glucose monitoring sensor into peripheral vascular IV line. | Device | – |
Primary outcome
A non-inferior design to demonstrate that the IVBG System is equivalent (non-inferior) to a POC meter with respect to the proportion of glucose measurements that are deemed acceptable using a metric defined in ISO 15197.
Time frame: During 72 hours of anticipated Sensor dwell time
1 secondary outcome
Accuracy of Device against YSI (Blood Glucose Analyser)
Time frame: During 72 hours of anticipated Sensor dwell time
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 20 Aug 2013.
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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.
Grand Bochicchio, MD principal investigator
University of Maryland Medical School
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Glucose, run by Edwards Lifesciences at 5 sites in United States.
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 2 inclusion and 9 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 20 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
A non-inferior design to demonstrate that the IVBG System is equivalent (non-inferior) to a POC meter with respect to the proportion of glucose measurements that are deemed acceptable using a metric defined in ISO 15197. (time frame: During 72 hours of anticipated Sensor dwell time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2013.