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Glucose Control In Hematopoetic Stem Cell Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00582036
Recruitment Status : Terminated (study terminated due to lack of enrollment)
First Posted : December 28, 2007
Results First Posted : April 22, 2011
Last Update Posted : April 22, 2011
Sponsor:
Collaborator:
Oklahoma Center for the Advancement of Science and Technology
Information provided by:
University of Oklahoma

Tracking Information
First Submitted Date  ICMJE December 19, 2007
First Posted Date  ICMJE December 28, 2007
Results First Submitted Date  ICMJE January 6, 2011
Results First Posted Date  ICMJE April 22, 2011
Last Update Posted Date April 22, 2011
Study Start Date  ICMJE February 2007
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2011)
Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT) [ Time Frame: 100 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
Intensive glucose control [ Time Frame: About 100 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
  • Reduction of Infection [ Time Frame: About 100 days ]
  • Reduced Length of In-hospital Stay [ Time Frame: About 100 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glucose Control In Hematopoetic Stem Cell Transplant
Official Title  ICMJE Glucose Control In Hematopoetic Stem Cell Transplant
Brief Summary To determine whether intensive glucose control results in improved mortality and reduced hospital stay length by performing a randomized trial of intensive glucose management (blood glucose goal 110 mg/dl) using continuous IV insulin and glucose vs. non-intensive glucose management (goal 200 mg/dl)
Detailed Description TO determine whether there are fewer infections, days without a fever, days on antibiotics given for an infection and time to marrow engraftment are improved by intensive glucose management; and to determine whether there is evidence of a reduction in measures of inflammation in patients randomized to intensive glucose management and whether reduction of inflammation is associated with outcome.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hyperglycemia
  • Hematopoietic Stem Cell Transplantation
Intervention  ICMJE
  • Drug: Regular Insulin
    Use of sliding scale insulin as per Appendix 1
  • Device: Deployment of the MiniMed Paradigm monitoring device
    Automated insulin delivery system
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Regular Sliding Scale Insulin administration for hyperglycemia
    Intervention: Drug: Regular Insulin
  • Experimental: Arm 2
    MiniMed Paradigm monitoring device for hyperglycemia
    Intervention: Device: Deployment of the MiniMed Paradigm monitoring device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 18, 2010)
11
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2007)
140
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients older than 18
  • Must meet standard criteria for HSCT
  • If patient is known diabetic at admit the may be maintained on home sulfonylurea and insulin if randomized to the conventional arm

Exclusion Criteria:

  • If on intensive arm patient must stop all oral hyperglycemic meds
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00582036
Other Study ID Numbers  ICMJE Glucose Control
OCAST HR06-13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Goerge Selby, MD, University of Oklahoma Health Sciences Center
Study Sponsor  ICMJE University of Oklahoma
Collaborators  ICMJE Oklahoma Center for the Advancement of Science and Technology
Investigators  ICMJE
Principal Investigator: George Selby, MD University of Oklahoma
PRS Account University of Oklahoma
Verification Date March 2011

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