Glucose Control In Hematopoetic Stem Cell Transplant

NCT00582036 | Terminated Results

• 2 other identifiers: 13219TOCAST HR06-13
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

To determine whether intensive glucose control results in improved mortality and reduced hospital stay length by performing a randomized trial of intensive glucose management (blood glucose goal 110 mg/dl) using continuous IV insulin and glucose vs. non-intensive glucose management (goal 200 mg/dl)

Conditions

Hyperglycemia; Hematopoietic Stem Cell Transplantation

Keywords

Hyperglycemia; Hematopoietic stem cell transplantation; Bone marrow transplant; High blood sugar

Outcome Measures

Primary Outcomes (1)

• Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT)

  100 days

Secondary Outcomes (2)

• Reduction of Infection

  About 100 days

• Reduced Length of In-hospital Stay

  About 100 days

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Regular Sliding Scale Insulin administration for hyperglycemia

Drug: Regular Insulin

Arm 2

EXPERIMENTAL

MiniMed Paradigm monitoring device for hyperglycemia

Device: Deployment of the MiniMed Paradigm monitoring device

Interventions

Regular Insulin DRUG

Use of sliding scale insulin as per Appendix 1

Arm 1

Deployment of the MiniMed Paradigm monitoring device DEVICE

Automated insulin delivery system

Arm 2

Eligibility Criteria

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

You may qualify if:

• Patients older than 18
• Must meet standard criteria for HSCT
• If patient is known diabetic at admit the may be maintained on home sulfonylurea and insulin if randomized to the conventional arm

You may not qualify if:

• If on intensive arm patient must stop all oral hyperglycemic meds

Sponsors & Collaborators

• University of Oklahoma: lead
• Oklahoma Center for the Advancement of Science and Technology: collaborator

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Hyperglycemia

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

This study was terminated early due to lack of enrollment.

Results Point of Contact

• Title: George Selby, MD
• Organization: University of Oklahoma Health Sciences Center

george-selby@ouhsc.edu

405-271-4022

Study Officials

• George Selby, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 28, 2007
• Study Start: February 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: April 20, 2026
• Results First Posted: April 22, 2011

Record last verified: 2026-03

Locations

US (1)