Trial Information
Use of Computer-Guided Glucose Management Systems for Patients Undergoing Blood and Marrow Transplants (BMT)
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.
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
- Women of childbearing potential not on 2 different forms of contraception
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Percentage of glucose values within target range (100-140) with a given CGGMS
Outcome Description:
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.
Outcome Time Frame:
At 6 months
Safety Issue:
No
Principal Investigator
Eunpi Cho
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Authority:
United States: Food and Drug Administration
Study ID:
2425.00
NCT ID:
NCT01236885
Start Date:
December 2012
Completion Date:
Related Keywords:
- 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
- Congenital Abnormalities
- Blast Crisis
- Burkitt Lymphoma
- Neoplasms
- Hodgkin Disease
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
- Leukemia, Myeloid, Accelerated Phase
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Leukemia, Myeloid, Chronic-Phase
- Leukemia, Myelomonocytic, Chronic
- Leukemia, Neutrophilic, Chronic
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Mycoses
- Mycosis Fungoides
- Myelodysplastic Syndromes
- Preleukemia
- Leukemia, Myelomonocytic, Acute
- Myeloproliferative Disorders
- Neuroblastoma
- Sezary Syndrome
- Testicular Neoplasms
- Trophoblastic Neoplasms
- Lymphoma, B-Cell
- Lymphoma, Large-Cell, Immunoblastic
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous
- Neoplasms, Germ Cell and Embryonal
- Hypereosinophilic Syndrome
- Lymphoma, B-Cell, Marginal Zone
- Lymphoma, Mantle-Cell
- Leukemia, Myelomonocytic, Juvenile
- Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
- Gestational Trophoblastic Neoplasms
- Myelodysplastic-Myeloproliferative Diseases
Name | Location |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
Seattle, Washington 98109 |