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

Hyperglycemia Clinical Trial

Official title:

Use of a Computer-Guided Glucose Management System for Patients Undergoing Blood and Marrow Transplants (BMT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236885
• Other study ID #: 2425.00
• Secondary ID: NCI-2010-0110224
• Status: Completed
• Phase: N/A
• First received: November 4, 2010
• Last updated: April 21, 2015
• Start date: December 2012

Study information

• Verified date: April 2015
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hyperglycemia
• Malignant Neoplasm
• Neoplasms

Intervention

Other:
• computer-assisted intervention
Undergo blood glucose management using Glucommander

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No