Hyperglycemia, Malignant Neoplasm
Conditions
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.
Interventions
Undergo blood glucose management using Glucommander
Sponsors
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of glucose values within target range (100-140) by using CGGMS | Up to 2 years | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients who experience severe hypoglycemia (defined as at least one blood glucose value less than 40) | Up to 2 years | 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) | Up to 2 years | 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 | 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 hypoglycemia (defined as at least one blood glucose value less than 70) | Up to 2 years | 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 | Up to 2 years | 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) | Up to 2 years | 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 | Up to 2 years | 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 | 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. |
Countries
United States
Outcome results
None listed