Official Title

Glucose Control In Hematopoetic Stem Cell Transplant
  • Phase

    N/A
  • Study Type

    Interventional
  • Intervention/Treatment

    insulin human ...
  • Study Participants

    11
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)
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 Started
Feb 28
2007
Primary Completion
May 31
2009
Study Completion
May 31
2009
Results Posted
Apr 22
2011
Estimate
Last Update
Apr 22
2011
Estimate

Drug Regular Insulin

Use of sliding scale insulin as per Appendix 1

Device Deployment of the MiniMed Paradigm monitoring device

Automated insulin delivery system

Arm 1 Active Comparator

Regular Sliding Scale Insulin administration for hyperglycemia

Arm 2 Experimental

MiniMed Paradigm monitoring device for hyperglycemia

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

Summary

Arm 1

Arm 2

All Events

Event Type Organ System Event Term

Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT)

Arm 1

Arm 2

Reduction of Infection

Outcome Measure Data Not Reported

Reduced Length of In-hospital Stay

Outcome Measure Data Not Reported

Total

11
Participants

Age Continuous

59
years (Mean)
Standard Deviation: 2

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Arm 1

Arm 2

Drop/Withdrawal Reasons

Arm 2