HyperglycemiaNCT01236885
Computer-Guided Glucose Management Systems in Treating Patients With Hyperglycemia Who Have Undergone Blood and Bone Marrow Transplant
A study testing computer-assisted intervention in people with Hyperglycemia and Malignant Neoplasm, run by Fred Hutchinson Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia, Malignant Neoplasm
- What is being tested?
- computer-assisted intervention
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2012to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Use of a Computer-Guided Glucose Management System for Patients Undergoing Blood and Marrow Transplants (BMT)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Hyperglycemia, Malignant Neoplasm
- Being tested
- computer-assisted intervention
- Medical subject headings
- Hyperglycemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer-assisted interventionOther
Undergo blood glucose management using Glucommander
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (Glucommander) | Experimental | Patients receive blood glucose management with IV insulin using Glucommander. Receives: Other: computer-assisted intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Secondary outcomes (8)
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.
Measured: Up to 2 years
Percentage of patients who experience severe hypoglycemia (defined as at least one blood glucose value less than 40)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startDec 2012
- Primary completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Merav Bar, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236885
- Sponsor's protocol ID
- 2425.00
- Other IDs
- NCI-2010-01102, 2425.00, P30CA015704
- Status last verified
- Apr 2015
- First submitted
- 4 Nov 2010
- Last updated
- 23 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Computer-Guided Glucose Management System for Patients Undergoing Blood and Marrow Transplants (BMT)
- ClinicalTrials.gov ID
- NCT01236885
- Acronym / sponsor ID
- 2425.00
- Conditions
- Hyperglycemia, Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2012
- Primary completion
- Feb 2015 (actual)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (Glucommander) | Experimental | Other: computer-assisted interventionPatients receive blood glucose management with IV insulin using Glucommander. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Post-transplant adult patients (age >= 18 years) on the BMT Service at UWMC
- Requiring insulin secondary to:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computer-assisted interventionUndergo blood glucose management using Glucommander | Other | Supportive care (Glucommander) |
Primary outcome
Percentage of glucose values within target range (100-140) by using CGGMS
Time frame: 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.
8 secondary outcomes
Percentage of patients who experience hypoglycemia (defined as at least one blood glucose value less than 70)
Time frame: Up to 2 years
Percentage of patients who experience severe hypoglycemia (defined as at least one blood glucose value less than 40)
Time frame: Up to 2 years
Mean time to target range (100-140)
Time frame: 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
Time frame: 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
Time frame: 24 hours after initiation of infusion
Number of values greater than 200 or less than 70 per patient per day of treatment
Time frame: Up to 2 years
Glucose variability (defined as standard deviation of individual blood glucose values)
Time frame: Up to 2 years
Nursing satisfaction evaluated by the Glucose Monitoring Tool Trial Evaluation Form
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merav Bar principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computer-assisted intervention in people with Hyperglycemia and Malignant Neoplasm, run by Fred Hutchinson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of glucose values within target range (100-140) by using CGGMS (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2015.