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

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ClinicalTrials.gov Identifier: NCT01236885
Recruitment Status : Completed
First Posted : November 9, 2010
Last Update Posted : April 23, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Hyperglycemia Malignant Neoplasm Other: computer-assisted intervention

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Use of a Computer-Guided Glucose Management System for Patients Undergoing Blood and Marrow Transplants (BMT)
Study Start Date : December 2012
Primary Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Supportive care (Glucommander)
Patients receive blood glucose management with IV insulin using Glucommander.
Other: computer-assisted intervention
Undergo blood glucose management using Glucommander


Outcome Measures

Primary Outcome Measures :
  1. Percentage of glucose values within target range (100-140) by using CGGMS [ Time Frame: Up to 2 years ]
    Standard statistical methods for rate and proportions will be used to assess binary outcomes, and standard methods for continuous data will be used for quantitative outcomes.


Secondary Outcome Measures :
  1. Percentage of patients who experience hypoglycemia (defined as at least one blood glucose value less than 70) [ Time Frame: Up to 2 years ]
    Standard statistical methods for rate and proportions will be used to assess binary outcomes, and standard methods for continuous data will be used for quantitative outcomes.

  2. Percentage of patients who experience severe hypoglycemia (defined as at least one blood glucose value less than 40) [ Time Frame: Up to 2 years ]
    Standard statistical methods for rate and proportions will be used to assess binary outcomes, and standard methods for continuous data will be used for quantitative outcomes.

  3. Mean time to target range (100-140) [ Time Frame: Up to 2 years ]
    Standard statistical methods for rate and proportions will be used to assess binary outcomes, and standard methods for continuous data will be used for quantitative outcomes.

  4. Percentage of patients who experience hyperglycemia (defined as at least one blood glucose value greater than 200) 24 hours after initiation of infusion [ Time Frame: 24 hours after initiation of infusion ]
    Standard statistical methods for rate and proportions will be used to assess binary outcomes, and standard methods for continuous data will be used for quantitative outcomes.

  5. Percentage of patients who experience severe hyperglycemia (defined as at least one blood glucose value greater than 300) 24 hours after initiation of infusion [ Time Frame: 24 hours after initiation of infusion ]
    Standard statistical methods for rate and proportions will be used to assess binary outcomes, and standard methods for continuous data will be used for quantitative outcomes.

  6. Number of values greater than 200 or less than 70 per patient per day of treatment [ Time Frame: Up to 2 years ]
    Standard statistical methods for rate and proportions will be used to assess binary outcomes, and standard methods for continuous data will be used for quantitative outcomes.

  7. Glucose variability (defined as standard deviation of individual blood glucose values) [ Time Frame: Up to 2 years ]
    Standard statistical methods for rate and proportions will be used to assess binary outcomes, and standard methods for continuous data will be used for quantitative outcomes.

  8. Nursing satisfaction evaluated by the Glucose Monitoring Tool Trial Evaluation Form [ Time Frame: Up to 2 years ]
    Standard statistical methods for rate and proportions will be used to assess binary outcomes, and standard methods for continuous data will be used for quantitative outcomes.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01236885


Locations
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Merav Bar Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
More Information

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01236885     History of Changes
Other Study ID Numbers: 2425.00
NCI-2010-01102 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2425.00 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: November 9, 2010    Key Record Dates
Last Update Posted: April 23, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Hyperglycemia
Neoplasms
Glucose Metabolism Disorders
Metabolic Diseases