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

This study is currently recruiting participants.
Verified March 2014 by Fred Hutchinson Cancer Research Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01236885
First received: November 4, 2010
Last updated: March 3, 2014
Last verified: March 2014

November 4, 2010
March 3, 2014
December 2012
July 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 intravenous (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
  • Other: computer-assisted intervention
    Undergo blood glucose management using GlucoCare
  • Other: computer-assisted intervention
    Undergo blood glucose management using Glucommander
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Post-transplant adult patients (age >= 18 years) on the bone marrow transplant (BMT) Service at University of Washington medical center (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
Both
18 Years and older
No
Not Provided
United States
 
NCT01236885
2425.00, NCI-2010-01102, 2425.00, P30CA015704
Not Provided
Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Principal Investigator: Eunpi Cho Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Fred Hutchinson Cancer Research Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP