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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-01102 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2425.00 | Other Identifier | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (Glucommander) | Experimental | Patients receive blood glucose management with IV insulin using Glucommander. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| computer-assisted intervention | Other | Undergo blood glucose management using Glucommander |
|
| 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 |
| 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) |
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Inclusion Criteria:
Post-transplant adult patients (age >= 18 years) on the BMT Service at UWMC
Requiring insulin secondary to:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merav Bar | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States | ||
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
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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 |
| Seattle |
| Washington |
| 98109 |
| United States |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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