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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hyperglycemia, Malignant Neoplasm

Intervention / Treatment
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* Other: computer-assisted intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (Glucommander)<br>Patients receive blood glucose management with IV insulin using Glucommander. | Other: computer-assisted intervention<br>* Undergo blood glucose management using Glucommander<br>|

What is the study measuring?
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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 |