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Improving Glycemic Control on GMS: A Quality Improvement Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Brigham and Women's Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00271700
First Posted: January 4, 2006
Last Update Posted: May 5, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novo Nordisk A/S
Information provided by:
Brigham and Women's Hospital
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Improving Glycemic Control on GMS: A Quality Improvement Study

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: May 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00271700


Contacts
Contact: Jeffrey L. Schnipper, MD, MPH 617-732-6201 jschnipper@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02120
Sponsors and Collaborators
Brigham and Women's Hospital
Novo Nordisk A/S
Investigators
Principal Investigator: Jeffrey L Schnipper, MD, MPH Brigham and Women's Hospital
  More Information

Responsible Party: Jeffrey L. Schnipper, MD, MPH, Brigham & Women's Hospital
ClinicalTrials.gov Identifier: NCT00271700     History of Changes
Other Study ID Numbers: 2005-P-001880/1
First Submitted: December 30, 2005
First Posted: January 4, 2006
Last Update Posted: May 5, 2010
Last Verified: May 2010

Keywords provided by Brigham and Women's Hospital:
Diabetes Mellitus
Outcome Assessment (Healthcare)
Inpatients
Hospital Information Systems
Education

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases