Glucose Control In Hematopoetic Stem Cell Transplant

University of Oklahoma (OU)

Status: Terminated

Conditions: Hyperglycemia; Hematopoietic Stem Cell Transplantation

Treatments: Device: Deployment of the MiniMed Paradigm monitoring device; Drug: Regular Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT00582036

Glucose Control

OCAST HR06-13

Details and patient eligibility

About

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)

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Arm 1

Active Comparator group

Description:

Regular Sliding Scale Insulin administration for hyperglycemia

Treatment:

Drug: Regular Insulin

Arm 2

Experimental group

Description:

MiniMed Paradigm monitoring device for hyperglycemia

Treatment:

Device: Deployment of the MiniMed Paradigm monitoring device