Glucose Control In Hematopoetic Stem Cell Transplant

This study has been terminated.
(study terminated due to lack of enrollment)
Sponsor:
Collaborator:
Oklahoma Center for the Advancement of Science and Technology
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00582036
First received: December 19, 2007
Last updated: March 23, 2011
Last verified: March 2011
  Purpose

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 Intervention
Hyperglycemia
Hematopoietic Stem Cell Transplantation
Drug: Regular Insulin
Device: Deployment of the MiniMed Paradigm monitoring device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Glucose Control In Hematopoetic Stem Cell Transplant

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT) [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reduction of Infection [ Time Frame: About 100 days ] [ Designated as safety issue: No ]
  • Reduced Length of In-hospital Stay [ Time Frame: About 100 days ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: February 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 19, 2007
Results First Received: January 6, 2011
Last Updated: March 23, 2011
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014