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Glucose Control In Hematopoetic Stem Cell Transplant

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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:
Information provided by:

Study Description
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)

Condition or disease Intervention/treatment
Hyperglycemia Hematopoietic Stem Cell Transplantation Drug: Regular Insulin Device: Deployment of the MiniMed Paradigm monitoring device

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Glucose Control In Hematopoetic Stem Cell Transplant
Study Start Date : February 2007
Primary Completion Date : May 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Arm 1
Regular Sliding Scale Insulin administration for hyperglycemia
Drug: Regular Insulin
Use of sliding scale insulin as per Appendix 1
Experimental: Arm 2
MiniMed Paradigm monitoring device for hyperglycemia
Device: Deployment of the MiniMed Paradigm monitoring device
Automated insulin delivery system


Outcome Measures

Primary Outcome Measures :
  1. Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT) [ Time Frame: 100 days ]

Secondary Outcome Measures :
  1. Reduction of Infection [ Time Frame: About 100 days ]
  2. Reduced Length of In-hospital Stay [ Time Frame: About 100 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00582036


Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Oklahoma Center for the Advancement of Science and Technology
Investigators
Principal Investigator: George Selby, MD University of Oklahoma
More Information

Responsible Party: Goerge Selby, MD, University of Oklahoma Health Sciences Center
ClinicalTrials.gov Identifier: NCT00582036     History of Changes
Other Study ID Numbers: Glucose Control
OCAST HR06-13
First Posted: December 28, 2007    Key Record Dates
Results First Posted: April 22, 2011
Last Update Posted: April 22, 2011
Last Verified: March 2011

Keywords provided by University of Oklahoma:
Hyperglycemia
Hematopoietic stem cell transplantation
Bone marrow transplant
High blood sugar

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs