Clinical trial NCT01236885: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Malignant Neoplasm
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-11-09
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Percentage of glucose values within target range (100-140) by using CGGMS
timeFrame: Up to 2 years
Secondary outcomes:
measure: Percentage of patients who experience hypoglycemia (defined as at least one blood glucose value less than 70)
timeFrame: Up to 2 years
measure: Percentage of patients who experience severe hypoglycemia (defined as at least one blood glucose value less than 40)
timeFrame: Up to 2 years
measure: Mean time to target range (100-140)
timeFrame: Up to 2 years
measure: Percentage of patients who experience hyperglycemia (defined as at least one blood glucose value greater than 200) 24 hours after initiation of infusion
timeFrame: 24 hours after initiation of infusion
measure: Percentage of patients who experience severe hyperglycemia (defined as at least one blood glucose value greater than 300) 24 hours after initiation of infusion
timeFrame: 24 hours after initiation of infusion
measure: Number of values greater than 200 or less than 70 per patient per day of treatment
timeFrame: Up to 2 years
measure: Glucose variability (defined as standard deviation of individual blood glucose values)
timeFrame: Up to 2 years
measure: Nursing satisfaction evaluated by the Glucose Monitoring Tool Trial Evaluation Form
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
name: Merav Bar
role: PRINCIPAL_INVESTIGATOR
References: