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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Malignant Neoplasm
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of glucose values within target range (100-140) by using CGGMS	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.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients who experience hypoglycemia (defined as at least one blood glucose value less than 70)	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.	Up to 2 years
Percentage of patients who experience severe hypoglycemia (defined as at least one blood glucose value less than 40)	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.	Up to 2 years
Mean time to target range (100-140)	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.	Up to 2 years
Percentage of patients who experience hyperglycemia (defined as at least one blood glucose value greater than 200) 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.	24 hours after initiation of infusion
Percentage of patients who experience severe hyperglycemia (defined as at least one blood glucose value greater than 300) 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.	24 hours after initiation of infusion
Number of values greater than 200 or less than 70 per patient per day of treatment	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.	Up to 2 years
Glucose variability (defined as standard deviation of individual blood glucose values)	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.	Up to 2 years
Nursing satisfaction evaluated by the Glucose Monitoring Tool Trial Evaluation Form	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.	Up to 2 years

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Merav Bar, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: November 4, 2010
• First Submitted That Met QC Criteria: November 5, 2010
• First Posted (Estimate): November 9, 2010

Study Record Updates

• Last Update Posted (Estimate): April 23, 2015
• Last Update Submitted That Met QC Criteria: April 21, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Neoplasms
• Other Study ID Numbers: 2425.00 (Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium); P30CA015704 (U.S. NIH Grant/Contract); NCI-2010-01102 (Registry Identifier: CTRP (Clinical Trial Reporting Program))