Computer-Guided Glucose Management Systems in Treating Patients With Hyperglycemia Who Have Undergone Blood and Bone Marrow Transplant

NCT ID: NCT01236885

Last Updated: 2015-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Brief Summary

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This clinical trial studies computer-guided glucose management systems in treating patients with hyperglycemia who have undergone blood and bone marrow transplant. A computer-guided glucose management system may help manage glucose levels in patients who have undergone blood or bone marrow transplant.

Detailed Description

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PRIMARY OBJECTIVES:

I. To examine the ability of computer-guided glucose management system (CGGMS) algorithms to control glucose within or close to current University of Washington Medical Center (UWMC) intensive care unit (ICU) targets (100 to 140 mg/dl) in non-critically ill bone marrow transplant (BMT) adult (age \>= 18 years) patients.

OUTLINE:

Patients receive blood glucose management with intravenous (IV) insulin using Glucommander.

Conditions

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Hyperglycemia Malignant Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive care (Glucommander)

Patients receive blood glucose management with IV insulin using Glucommander.

Group Type EXPERIMENTAL

computer-assisted intervention

Intervention Type OTHER

Undergo blood glucose management using Glucommander

Interventions

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computer-assisted intervention

Undergo blood glucose management using Glucommander

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Post-transplant adult patients (age \>= 18 years) on the BMT Service at UWMC
* Requiring insulin secondary to:

* Known history of (h/o) type 2 diabetes mellitus
* Two blood sugar values \> 180 (point of care and/or am lab glycemia)
* One blood sugar value \> 250 (point of care or AM lab glycemia)

Exclusion Criteria

* Critically ill patients (intensive care unit \[ICU\] admissions)
* Terminally ill patients
* Eastern Cooperative Oncology Group (ECOG) performance status \> 3
* Previous type 1 diabetes mellitus
* Cognitively impaired patients, unable to consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Merav Bar

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Locations

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Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Site Status

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2010-01102

Identifier Type: REGISTRY

Identifier Source: secondary_id

2425.00

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2425.00

Identifier Type: -

Identifier Source: org_study_id

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