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

Not Applicable

Completed

• Conditions: Hyperglycemia; Malignant Neoplasm
• Interventions: Other: computer-assisted intervention

• Registration Number: NCT01236885
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2010-11-04
• Study First Submitted QC: 2010-11-05
• Study First Posted: 2010-11-09
• Study Start: 2012-12
• Primary Completion: 2015-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (Glucommander)	computer-assisted intervention	Patients receive blood glucose management with IV insulin using Glucommander.

Primary Outcome Measures

Name	Time	Method
Percentage of glucose values within target range (100-140) by using CGGMS	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 Outcome Measures

Name	Time	Method
Percentage of patients who experience hypoglycemia (defined as at least one blood glucose value less than 70)	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.
Percentage of patients who experience hyperglycemia (defined as at least one blood glucose value greater than 200) 24 hours after initiation of infusion	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.
Percentage of patients who experience severe hyperglycemia (defined as at least one blood glucose value greater than 300) 24 hours after initiation of infusion	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.
Number of values greater than 200 or less than 70 per patient per day of treatment	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.
Percentage of patients who experience severe hypoglycemia (defined as at least one blood glucose value less than 40)	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.
Mean time to target range (100-140)	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.
Glucose variability (defined as standard deviation of individual blood glucose values)	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.
Nursing satisfaction evaluated by the Glucose Monitoring Tool Trial Evaluation Form	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.

Trial Locations

Locations (2)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States