Glucose Control In Hematopoetic Stem Cell Transplant

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-05-31

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Hyperglycemia Hematopoietic Stem Cell Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Regular Sliding Scale Insulin administration for hyperglycemia

Group Type ACTIVE_COMPARATOR

Regular Insulin

Intervention Type DRUG

Use of sliding scale insulin as per Appendix 1

Arm 2

MiniMed Paradigm monitoring device for hyperglycemia

Group Type EXPERIMENTAL

Deployment of the MiniMed Paradigm monitoring device

Intervention Type DEVICE

Automated insulin delivery system

Interventions

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Regular Insulin

Use of sliding scale insulin as per Appendix 1

Intervention Type DRUG

Deployment of the MiniMed Paradigm monitoring device

Automated insulin delivery system

Intervention Type DEVICE

Eligibility Criteria

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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