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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Fred Hutchinson Cancer Research Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01236885
First received: November 4, 2010
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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 Intervention
Hyperglycemia
Malignant Neoplasm
Other: computer-assisted intervention

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Use of a Computer-Guided Glucose Management System for Patients Undergoing Blood and Marrow Transplants (BMT)

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Percentage of glucose values within target range (100-140) by using CGGMS [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    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:
  • Percentage of patients who experience hypoglycemia (defined as at least one blood glucose value less than 70) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    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.

  • Percentage of patients who experience severe hypoglycemia (defined as at least one blood glucose value less than 40) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    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.

  • Mean time to target range (100-140) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Number of values greater than 200 or less than 70 per patient per day of treatment [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    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.

  • Glucose variability (defined as standard deviation of individual blood glucose values) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    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.

  • Nursing satisfaction evaluated by the Glucose Monitoring Tool Trial Evaluation Form [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: December 2012
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supportive care (Glucommander)
Patients receive blood glucose management with IV insulin using Glucommander.
Other: computer-assisted intervention
Undergo blood glucose management using Glucommander

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • Women of childbearing potential not on 2 different forms of contraception
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01236885

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Paul V. O'Donnell    617-726-2000      
Principal Investigator: Paul V. O'Donnell         
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Merav Bar    206-667-4971      
Principal Investigator: Merav Bar         
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Merav Bar Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01236885     History of Changes
Other Study ID Numbers: 2425.00, NCI-2010-01102, 2425.00, P30CA015704
Study First Received: November 4, 2010
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 26, 2014