Back to resultsGlucose Control In Hematopoetic Stem Cell Transplant
Primary Purpose
Hyperglycemia, Hematopoietic Stem Cell Transplantation
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Regular Insulin
Deployment of the MiniMed Paradigm monitoring device
Sponsored by
About this trial
This is an interventional treatment trial for Hyperglycemia focused on measuring Hyperglycemia, Hematopoietic stem cell transplantation, Bone marrow transplant, High blood sugar
Eligibility 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
Sites / Locations
- University of Oklahoma Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm 1
Arm 2
Arm Description
Regular Sliding Scale Insulin administration for hyperglycemia
MiniMed Paradigm monitoring device for hyperglycemia
Outcomes
Primary Outcome Measures
Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT)
Secondary Outcome Measures
Reduction of Infection
Reduced Length of In-hospital Stay
Full Information
NCT ID
NCT00582036
First Posted
December 19, 2007
Last Updated
March 23, 2011
Sponsor
University of Oklahoma
Collaborators
Oklahoma Center for the Advancement of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT00582036
Brief Title
Glucose Control In Hematopoetic Stem Cell Transplant
Official Title
Glucose Control In Hematopoetic Stem Cell Transplant
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Terminated
Why Stopped
study terminated due to lack of enrollment
Study Start Date
February 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Oklahoma
Collaborators
Oklahoma Center for the Advancement of Science and Technology
4. Oversight
Data Monitoring Committee
No
5. 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)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Hematopoietic Stem Cell Transplantation
Keywords
Hyperglycemia, Hematopoietic stem cell transplantation, Bone marrow transplant, High blood sugar
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
Regular Sliding Scale Insulin administration for hyperglycemia
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
MiniMed Paradigm monitoring device for hyperglycemia
Intervention Type
Drug
Intervention Name(s)
Regular Insulin
Intervention Description
Use of sliding scale insulin as per Appendix 1
Intervention Type
Device
Intervention Name(s)
Deployment of the MiniMed Paradigm monitoring device
Intervention Description
Automated insulin delivery system
Primary Outcome Measure Information:
Title
Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT)
Time Frame
100 days
Secondary Outcome Measure Information:
Title
Reduction of Infection
Time Frame
About 100 days
Title
Reduced Length of In-hospital Stay
Time Frame
About 100 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Selby, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Glucose Control In Hematopoetic Stem Cell Transplant
We'll reach out to this number within 24 hrs