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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 October 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: October 1, 2014
Last verified: October 2014

November 4, 2010
October 1, 2014
December 2012
July 2015   (final data collection date for primary outcome measure)
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.
Percentage of glucose values within target range (101-150) with a given CGGMS [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01236885 on ClinicalTrials.gov Archive Site
  • 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.
  • Percentage of patients who experience hypoglycemia (defined as at least one blood glucose value < 70) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • Percentage of patients who experience severe hypoglycemia (defined as at least one blood glucose value < 40) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • Mean time to target range (101-150) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • Percentage of patients who experience hyperglycemia(defined as at least one blood glucose value > 200) 24 hours after initiation of infusion [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • Percentage of patients who experience severe hyperglycemia (defined as at least one blood glucose value > 300) 24 hours after initiation of infusion [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • Number of values > 200 or < 70 per patient per day of treatment. [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • Glucose variability (defined as standard deviation of individual blood glucose values) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • Nursing satisfaction evaluated by a survey [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Computer-Guided Glucose Management Systems in Treating Patients With Hyperglycemia Who Have Undergone Blood and Bone Marrow Transplant
Use of a Computer-Guided Glucose Management System for Patients Undergoing Blood and Marrow Transplants (BMT)

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Hyperglycemia
  • Malignant Neoplasm
Other: computer-assisted intervention
Undergo blood glucose management using Glucommander
Experimental: Supportive care (Glucommander)
Patients receive blood glucose management with IV insulin using Glucommander.
Intervention: Other: computer-assisted intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
July 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT01236885
2425.00, NCI-2010-01102, 2425.00, P30CA015704
Not Provided
Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Principal Investigator: Merav Bar Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Fred Hutchinson Cancer Research Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP