Skip to main content
OpenTrials
Completed

NCT Number: NCT01236885

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hyperglycemia Glucose Metabolism Disorders Malignant Neoplasm Metabolic Diseases Neoplasms Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer-Assisted Intervention

Other

Undergo blood glucose management using Glucommander

Primary outcomes

  1. 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.

Secondary outcomes

  1. Percentage of patients who experience hypoglycemia (defined as at least one blood glucose value less than 70)

    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.

  2. Percentage of patients who experience severe hypoglycemia (defined as at least one blood glucose value less than 40)

    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.

  3. Mean time to target range (100-140)

    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.

  4. 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

    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.

  5. 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

    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.

  6. Number of values greater than 200 or less than 70 per patient per day of treatment

    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.

  7. Glucose variability (defined as standard deviation of individual blood glucose values)

    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. Nursing satisfaction evaluated by the Glucose Monitoring Tool Trial Evaluation Form

    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.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Use of a Computer-Guided Glucose Management System for Patients Undergoing Blood and Marrow Transplants (BMT)

Important dates

Study start
2012
Primary completion
2015
First posted
Nov 9, 2010
Registry last updated
Apr 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.