Clinical Study of the Intravenous Blood Glucose System in Hospitalized Adult Elective or Non-Emergent Surgery and Medical/Surgical Intensive Care Unit Patients

This study has been completed.
Sponsor:
Collaborators:
DexCom, Inc.
Medical Device Consultants, Inc.
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT00906490
First received: May 20, 2009
Last updated: August 16, 2013
Last verified: August 2013

May 20, 2009
August 16, 2013
June 2009
April 2010   (final data collection date for 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 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00906490 on ClinicalTrials.gov Archive Site
Accuracy of Device against YSI (Blood Glucose Analyser) [ Time Frame: During 72 hours of anticipated Sensor dwell time ] [ Designated as safety issue: No ]
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Clinical Study of the Intravenous Blood Glucose System in Hospitalized Adult Elective or Non-Emergent Surgery and Medical/Surgical Intensive Care Unit Patients
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Acute care facility patient with a minimum of 24 hour ICU stay.

Blood Glucose
Device: Intravenous Blood Glucose monitoring system
Insertion of blood glucose monitoring sensor into peripheral vascular IV line.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
May 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ICU ≥ 24 hours
  • sign ICF

Exclusion Criteria:

  • transplant Pt
  • brain injury/surgery
  • DKA
  • end stage disease
  • restricted venous access
  • hx of HITT
  • contraindication for anti-coagulation Tx
  • positive pregnancy test
  • in other drug, device, or biologic study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00906490
2008-11
No
Edwards Lifesciences
Edwards Lifesciences
  • DexCom, Inc.
  • Medical Device Consultants, Inc.
Principal Investigator: Grand Bochicchio, MD University of Maryland Medical School
Edwards Lifesciences
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP