search
Back to results

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

Primary Purpose

Hyperglycemia, Malignant Neoplasm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
computer-assisted intervention
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hyperglycemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital Cancer Center
  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (Glucommander)

Arm Description

Patients receive blood glucose management with IV insulin using Glucommander.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 4, 2010
Last Updated
April 21, 2015
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT01236885
Brief Title
Computer-Guided Glucose Management Systems in Treating Patients With Hyperglycemia Who Have Undergone Blood and Bone Marrow Transplant
Official Title
Use of a Computer-Guided Glucose Management System for Patients Undergoing Blood and Marrow Transplants (BMT)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Malignant Neoplasm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (Glucommander)
Arm Type
Experimental
Arm Description
Patients receive blood glucose management with IV insulin using Glucommander.
Intervention Type
Other
Intervention Name(s)
computer-assisted intervention
Intervention Description
Undergo blood glucose management using Glucommander
Primary Outcome Measure Information:
Title
Percentage of glucose values within target range (100-140) by using CGGMS
Description
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.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Percentage of patients who experience hypoglycemia (defined as at least one blood glucose value less than 70)
Description
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.
Time Frame
Up to 2 years
Title
Percentage of patients who experience severe hypoglycemia (defined as at least one blood glucose value less than 40)
Description
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.
Time Frame
Up to 2 years
Title
Mean time to target range (100-140)
Description
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.
Time Frame
Up to 2 years
Title
Percentage of patients who experience hyperglycemia (defined as at least one blood glucose value greater than 200) 24 hours after initiation of infusion
Description
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.
Time Frame
24 hours after initiation of infusion
Title
Percentage of patients who experience severe hyperglycemia (defined as at least one blood glucose value greater than 300) 24 hours after initiation of infusion
Description
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.
Time Frame
24 hours after initiation of infusion
Title
Number of values greater than 200 or less than 70 per patient per day of treatment
Description
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.
Time Frame
Up to 2 years
Title
Glucose variability (defined as standard deviation of individual blood glucose values)
Description
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.
Time Frame
Up to 2 years
Title
Nursing satisfaction evaluated by the Glucose Monitoring Tool Trial Evaluation Form
Description
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.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merav Bar
Organizational Affiliation
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs