Glucose Control In Hematopoetic Stem Cell Transplant

Not Applicable

Terminated

• Conditions: Hyperglycemia; Hematopoietic Stem Cell Transplantation
• Interventions: Drug: Regular Insulin; Device: Deployment of the MiniMed Paradigm monitoring device

• Registration Number: NCT00582036
• Lead Sponsor: University of Oklahoma

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 Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-28
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2011-01-06
• Results First Submitted QC: 2011-03-23
• Results First Posted: 2011-04-22
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Regular Insulin	Regular Sliding Scale Insulin administration for hyperglycemia
Arm 2	Deployment of the MiniMed Paradigm monitoring device	MiniMed Paradigm monitoring device for hyperglycemia

Primary Outcome Measures

Name	Time	Method
Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT)	100 days

Secondary Outcome Measures

Name	Time	Method
Reduction of Infection	About 100 days
Reduced Length of In-hospital Stay	About 100 days

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States