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

NCT01236885 | Completed

• 3 other identifiers: 2425.00NCI-2010-01102P30CA015704
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

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.

Conditions

Hyperglycemia; Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 2 years

Secondary Outcomes (8)

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

  Up to 2 years

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

  Up to 2 years

• Mean time to target range (100-140)

  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

  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

  24 hours after initiation of infusion

Study Arms (1)

Supportive care (Glucommander)

EXPERIMENTAL

Patients receive blood glucose management with IV insulin using Glucommander.

Other: computer-assisted intervention

Interventions

computer-assisted intervention OTHER

Undergo blood glucose management using Glucommander

Supportive care (Glucommander)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Hyperglycemia; Neoplasms

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Merav Bar

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2010
• First Posted: November 9, 2010
• Study Start: December 1, 2012
• Primary Completion: February 1, 2015
• Last Updated: April 23, 2015

Record last verified: 2015-04

Locations

US (2)