| November 4, 2010 |
| December 12, 2012 |
| December 2012 |
| January 2014 (final data collection date for primary outcome measure) |
| Percentage of glucose values within target range (100-140) with a given CGGMS [ Time Frame: At 6 months ] [ Designated as safety issue: No ] 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 glucose values within target range (101-150) with a given CGGMS [ Time Frame: At 6 months ] [ Designated as safety issue: No ] |
| Complete list of historical versions of study NCT01236885 on ClinicalTrials.gov Archive Site |
- Percentage of patients who experience hypoglycemia (defined as at least one blood glucose value less than 70) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
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 hypoglycemia (defined as at least one blood glucose value less than 40) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
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) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
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 [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
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 [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
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 [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
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) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
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 [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
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 < 70) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
- Percentage of patients who experience severe hypoglycemia (defined as at least one blood glucose value < 40) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
- Mean time to target range (101-150) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
- Percentage of patients who experience hyperglycemia(defined as at least one blood glucose value > 200) 24 hours after initiation of infusion [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
- Percentage of patients who experience severe hyperglycemia (defined as at least one blood glucose value > 300) 24 hours after initiation of infusion [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
- Number of values > 200 or < 70 per patient per day of treatment. [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
- Glucose variability (defined as standard deviation of individual blood glucose values) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
- Nursing satisfaction evaluated by a survey [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
|
| Not Provided |
| Not Provided |
| |
| Computer-Guided Glucose Management Systems in Treating Patients With Hyperglycemia Who Have Undergone Blood and Bone Marrow Transplant |
| Use of Computer-Guided Glucose Management Systems for Patients Undergoing Blood and Marrow Transplants (BMT) |
This clinical trial is studying computer-guided glucose management systems in treating patients with hyperglycemia who have undergone blood and bone marrow transplant. A computer-guided glucose management system (CGGMS) may help manage glucose levels in patients who have undergone blood or bone marrow transplant |
PRIMARY OBJECTIVES:
I. To determine whether using CGGMS algorithms in non-critically ill blood and marrow transplant (BMT) adult (age >= 18 years) patients, can control glucose within or close to current University of Washington Medical Center (UWMC) intensive care unit (ICU) targets (100 to 140mg/dl).
SECONDARY OBJECTIVES:
I. Compare two different CGGMS tools to see which reaches glycemic targets and which receives better nursing satisfaction.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients receive blood glucose management with IV insulin using GlucoCare.
GROUP II: Patients receive blood glucose management with IV insulin using Glucommander. |
| Interventional |
| Not Provided |
Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
- Accelerated Phase Chronic Myelogenous Leukemia
- Adult Acute Lymphoblastic Leukemia in Remission
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Adult Acute Myeloid Leukemia With Del(5q)
- Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
- Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
- Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
- Blastic Phase Chronic Myelogenous Leukemia
- Chronic Eosinophilic Leukemia
- Chronic Myelomonocytic Leukemia
- Chronic Neutrophilic Leukemia
- Chronic Phase Chronic Myelogenous Leukemia
- de Novo Myelodysplastic Syndromes
- Disseminated Neuroblastoma
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- High Risk Metastatic Gestational Trophoblastic Tumor
- Juvenile Myelomonocytic Leukemia
- Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
- Nodal Marginal Zone B-cell Lymphoma
- Noncontiguous Stage II Adult Burkitt Lymphoma
- Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
- Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma
- Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
- Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma
- Noncontiguous Stage II Adult Lymphoblastic Lymphoma
- Noncontiguous Stage II Grade 1 Follicular Lymphoma
- Noncontiguous Stage II Grade 2 Follicular Lymphoma
- Noncontiguous Stage II Grade 3 Follicular Lymphoma
- Noncontiguous Stage II Mantle Cell Lymphoma
- Noncontiguous Stage II Marginal Zone Lymphoma
- Noncontiguous Stage II Small Lymphocytic Lymphoma
- Previously Treated Myelodysplastic Syndromes
- Recurrent Adult Acute Myeloid Leukemia
- Recurrent Adult Burkitt Lymphoma
- Recurrent Adult Diffuse Large Cell Lymphoma
- Recurrent Adult Diffuse Mixed Cell Lymphoma
- Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
- Recurrent Adult Hodgkin Lymphoma
- Recurrent Adult Immunoblastic Large Cell Lymphoma
- Recurrent Adult Lymphoblastic Lymphoma
- Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
- Recurrent Grade 1 Follicular Lymphoma
- Recurrent Grade 2 Follicular Lymphoma
- Recurrent Grade 3 Follicular Lymphoma
- Recurrent Malignant Testicular Germ Cell Tumor
- Recurrent Mantle Cell Lymphoma
- Recurrent Marginal Zone Lymphoma
- Recurrent Mycosis Fungoides/Sezary Syndrome
- Recurrent Small Lymphocytic Lymphoma
- Refractory Chronic Lymphocytic Leukemia
- Refractory Multiple Myeloma
- Relapsing Chronic Myelogenous Leukemia
- Secondary Acute Myeloid Leukemia
- Secondary Myelodysplastic Syndromes
- Splenic Marginal Zone Lymphoma
- Stage I Multiple Myeloma
- Stage II Multiple Myeloma
- Stage III Adult Burkitt Lymphoma
- Stage III Adult Diffuse Large Cell Lymphoma
- Stage III Adult Diffuse Mixed Cell Lymphoma
- Stage III Adult Diffuse Small Cleaved Cell Lymphoma
- Stage III Adult Hodgkin Lymphoma
- Stage III Adult Immunoblastic Large Cell Lymphoma
- Stage III Adult Lymphoblastic Lymphoma
- Stage III Chronic Lymphocytic Leukemia
- Stage III Grade 1 Follicular Lymphoma
- Stage III Grade 2 Follicular Lymphoma
- Stage III Grade 3 Follicular Lymphoma
- Stage III Mantle Cell Lymphoma
- Stage III Marginal Zone Lymphoma
- Stage III Multiple Myeloma
- Stage III Small Lymphocytic Lymphoma
- Stage IV Adult Burkitt Lymphoma
- Stage IV Adult Diffuse Large Cell Lymphoma
- Stage IV Adult Diffuse Mixed Cell Lymphoma
- Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
- Stage IV Adult Hodgkin Lymphoma
- Stage IV Adult Immunoblastic Large Cell Lymphoma
- Stage IV Adult Lymphoblastic Lymphoma
- Stage IV Chronic Lymphocytic Leukemia
- Stage IV Grade 1 Follicular Lymphoma
- Stage IV Grade 2 Follicular Lymphoma
- Stage IV Grade 3 Follicular Lymphoma
- Stage IV Mantle Cell Lymphoma
- Stage IV Marginal Zone Lymphoma
- Stage IV Small Lymphocytic Lymphoma
|
|
|
- Experimental: Group I (GlucoCare)
Patients receive blood glucose management with IV insulin using GlucoCare.
Intervention: Other: computer-assisted intervention
- Experimental: Group II (Glucommander)
Patients receive blood glucose management with IV insulin using Glucommander.
Intervention: Other: computer-assisted intervention
|
| Not Provided |
| |
| Recruiting |
| 100 |
| Not Provided
| January 2014 (final data collection date for primary outcome measure) |
Inclusion Criteria:
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
- Women of childbearing potential not on 2 different forms of contraception
|
| Both |
| 18 Years and older |
| No |
| Not Provided
| United States |
| |
| NCT01236885 |
| 2425.00, NCI-2010-01102, P30CA015704 |
| Not Provided
| Not Provided
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
| National Cancer Institute (NCI) |
| Principal Investigator: |
Eunpi Cho |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
|
|
| Fred Hutchinson Cancer Research Center |
| December 2012 |