Improving Glycemic Control on GMS: A Quality Improvement Study

This study is not yet open for participant recruitment.

Verified by Brigham and Women's Hospital, December 2005

First Received: December 30, 2005 No Changes Posted

Sponsor:	Brigham and Women's Hospital
Collaborator:	Novo Nordisk
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00271700

Purpose

This study will examine whether new processes and technologies for monitoring diabetic patients' insulin levels improves patient care at Brigham and Women's Hospital.

Condition	Intervention
Diabetes Mellitus	Behavioral: Order Set, Education, Feedback

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Improving Glycemic Control on GMS: A Quality Improvement Study

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

- Point-of-care testing glucose values (percent of routine glucose readings between 60 and 180 mg/dL)
- Lab glucose values (percent of routine glucose readings between 60 and 180 mg/dL)

Secondary Outcome Measures:

- Quality of insulin orders using explicit criteria

Estimated Enrollment:	1100
Study Start Date:	March 2006

Detailed Description:

This study will examine whether new processed and technologies for monitoring diabetic patients' insulin levels improves patient care. Patients at Brigham and Women's Hospital (BWH), staying on the General Medicine Service, who have Type 2 diabetes and who are not on IV insulin can participate in this study. Physicians and nurses will be taught new rules to care for diabetic patients, while in the hospital. Also, the BWH computer system will be updated to include these new rules for administering insulin. Patients who participate in the study will be randomly placed into one of two groups: one group that will be cared for by physicians and nurses who have learned these new rules for administering insulin; or the second group, who will receive diabetes care at BWH before the new rules were adopted. The study will last approximately 1 year.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects will include all type 2 diabetic patients on the General Medicine Service (GMS) of Brigham and Women’s Hospital (BWH) who do not have an indication for IV insulin.

Exclusion Criteria:

Type 2 diabetic patients on the General Medicine Service (GMS) of Brigham and Women’s Hospital (BWH) who have an indication for IV insulin.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271700

Contacts

Contact: Jeffrey L. Schnipper, MD, MPH

617-732-6201

jschnipper@partners.org

Locations

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120

Sponsors and Collaborators

Brigham and Women's Hospital

Novo Nordisk

Investigators

Principal Investigator:

Jeffrey L Schnipper, MD, MPH

Brigham and Women's Hospital

More Information

No publications provided

Study ID Numbers:	2005-P-001880/1, 2005-P-001880/1
Study First Received:	December 30, 2005
Last Updated:	December 30, 2005
ClinicalTrials.gov Identifier:	NCT00271700 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:

Diabetes Mellitus
Outcome Assessment (Healthcare)
Inpatients
Hospital Information Systems
Education

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 09, 2010